AzTrials
AzTrials

HealthyFruiseniorNCT04482530

Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly (Fruisenior)

A study testing fruit paste matrice in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating. Read more about this study

Who is it for?
Ages 65 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
fruit paste matrice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteFrance
Study dates
31 May 2021to 19 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • Men only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Male subject
  • Subject over 65 years (included)
  • Subject over 61 kg (included)
  • Able to consume the 80g of fruit pastes in 10 minutes
  • Subject with a dentition consistent with the fruit paste consumption in 10 minutes
  • Subject with a Body Mass Index (BMI) between 21 and 30 kg/m2
  • Subject agreeing to provide written consent

Who cannot join

  • Subject with acute pathology (unstable or terminal pathology, severe dementia)
  • Subject with renal failure (clearance < 60 ml/min)
  • Subject with metabolic syndrome (3 of the following 5 criteria: waist greater than 94 cm, blood triglyceride greater than 1.7 mmol/l, blood pressure greater than or equal to 130 mm Hg/85 mm Hg, cholesterol (HDL) less than 1.0 mmol/l in men, blood glucose greater than or equal to 5.6 mmol/l)
  • Person with diabetes
  • Subject on food restriction
  • Subject undergoing chemotherapy
  • Subject with gastrointestinal pathology
  • Subject in a diet incompatible with the nutritional protocol (gluten, lactose or milk intolerance, vegan)

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

Other trials in France

About this study

Official title: Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept

To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.

Read the detailed description

This is an interventional randomized, single blinded, cross over and controlled study.

The main objective is the study of the kinetic modification of blood glucose with the "fruit" matrices enriched in maltodextrins, fructose and isomaltulose compared to the original recipe consisting only of simple sugars.

The secondary objective is:

-the assessment of the acceptability of all the fruit pastes tested (organoleptic, satiety and gastrointestinal comfort aspects).The study is composed of 7 visits Visit 1 - Selection Visit (Day -7)

  • Informed consent form
  • Clinical examination
  • Medical history
  • Anthropometric characteristics
  • Blood biochemical and hematological assessment
  • Compliance test with the original matrix will be carried out

Visit 2 (D0) / Visit 3 (D7) / Visit 4 (D14) / Visit 5 (D21) / Visit 6 (D28): study period If all the biological criteria are respected, the subjects will have to come back to the clinical center for each of the 5 study periods.

Volunteers will arrive fasted, without smoking in the morning. A catheter will be placed for blood sampling. After a first blood sampling for basal values, volunteers will ingest the equivalent of two bars of fruit pastes (about 80g in 10 minutes maximum) and blood will be withdrawn 15, 30, 45, 60, 90, 120 and 180 minutes after ingestion. The different matrices (5 in total) will be tested on the same volunteer. Plasma samples will be used to determine plasma glucose and fructose concentrations (aliquots stored in center for later assays) to evaluate the postprandial profiles of these two nutrients. At the end of the kinetic, the volunteers will be offered a complete meal. A satiety questionnaire will be performed before then 60 and 180 min after the ingestion of each fruit matrix. A questionnaire of satisfaction and acceptability will also be realized during the consumption of the matrix.

After the 5 fruit matrix will be tested, the subject will be invited to participate in an individual interview of about 30-45min with a member of the project team. The purpose of this interview will be a qualitative approach to search for a food development that can could improve the sensory quality of the fruit pastes tested and intended for the elderly (see below).

Visit 7 (D35 to D40): Participation in a discussion group (about 2 hours). During the participation in this group all 10 participants will be invited to taste the 5 products (original recipe, maltodextrin recipe, fructose recipe, isomaltulose recipe and mixed recipe comprising fructose and isomaltulose). Participants will be asked to indicate for each product their degree of appreciation for these products, their possible defects and qualities and to suggest ideas for improving their taste / texture / appearance. These interviews will alternate individual reflection phases and discussion phases according to the focus group method.

Visit 7 will be the last visit of the study.

Conditions
Healthy
Being tested
fruit paste matrice
Keywords
Fruit pastes matrices, Elderly healthy volunteer, Dietary intake

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fruit paste matriceOther

    Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.

Study groups in NCT04482530
Study groupRoleWhat they receive
Original recipeExperimentalNormal fruit paste
Receives: Other: fruit paste matrice
maltodextrin recipeExperimentalfruit pastes in which some of the simple sugars in the recipe will be replaced by maltodextrin with a low glycemic index (DE12).
Receives: Other: fruit paste matrice
fructose recipeExperimentalfruit pastes in which some of the simple sugars in the recipe (25% min) will be replaced by fructose
Receives: Other: fruit paste matrice
isomaltulose recipeExperimentalfruit pastes with some of the sugars will be replaced (25% min) by isomaltulose
Receives: Other: fruit paste matrice
mixed recipeExperimentalfruit pastes with some of the sugars will be replaced (25% min) by fructose / isomaltulose
Receives: Other: fruit paste matrice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Curve (AUC) of glycemia

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  2. Maximum Plasma Concentration (Cmax) of glycemia

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  3. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  4. Area Under the Curve (AUC) of glycemia

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 7

  5. Maximum Plasma Concentration (Cmax) of glycemia

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 7

  6. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 7

  7. Area Under the Curve (AUC) of glycemia

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  8. Maximum Plasma Concentration (Cmax) of glycemia

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  9. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  10. Area Under the Curve (AUC) of glycemia

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  11. Maximum Plasma Concentration (Cmax) of glycemia

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  12. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  13. Area Under the Curve (AUC) of glycemia

    Area Under the Curve (AUC) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  14. Maximum Plasma Concentration (Cmax) of glycemia

    Maximum Plasma Concentration (Cmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  15. Time of Maximum Plasma Concentration (Tmax) of glycemia

    Time of Maximum Plasma Concentration (Tmax) of glycemia (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

Secondary outcomes (157)

  1. Area Under the Curve (AUC) of fructose

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  2. Maximum Plasma Concentration (Cmax) of fructose

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  3. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  4. Area Under the Curve (AUC) of fructose

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 7

  5. Maximum Plasma Concentration (Cmax) of fructose

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 7

  6. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 7

  7. Area Under the Curve (AUC) of fructose

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 14

  8. Maximum Plasma Concentration (Cmax) of fructose

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 14

  9. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 14

  10. Area Under the Curve (AUC) of fructose

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 21

  11. Maximum Plasma Concentration (Cmax) of fructose

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 21

  12. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 21

  13. Area Under the Curve (AUC) of fructose

    Area Under the Curve (AUC) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 28

  14. Maximum Plasma Concentration (Cmax) of fructose

    Maximum Plasma Concentration (Cmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 28

  15. Time of Maximum Plasma Concentration (Tmax) of fructose

    Time of Maximum Plasma Concentration (Tmax) of fructose (defined in g/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 28

  16. Area Under the Curve (AUC) of glucagon

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  17. Maximum Plasma Concentration (Cmax) of glucagon

    : Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  18. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  19. Area Under the Curve (AUC) of glucagon

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  20. Maximum Plasma Concentration (Cmax) of glucagon

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  21. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 7

  22. Area Under the Curve (AUC) of glucagon

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 14

  23. Maximum Plasma Concentration (Cmax) of glucagon

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 14

  24. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 14

  25. Area Under the Curve (AUC) of glucagon

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 21

  26. Maximum Plasma Concentration (Cmax) of glucagon

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 21

  27. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 21

  28. Area Under the Curve (AUC) of glucagon

    Area Under the Curve (AUC) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 28

  29. Maximum Plasma Concentration (Cmax) of glucagon

    Maximum Plasma Concentration (Cmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 28

  30. Time of Maximum Plasma Concentration (Tmax) of glucagon

    Time of Maximum Plasma Concentration (Tmax) of glucagon (defined in np/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 28

  31. Area Under the Curve (AUC) of CCK

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  32. Maximum Plasma Concentration (Cmax) of CCK

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 0

  33. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  34. Area Under the Curve (AUC) of CCK

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 7

  35. Maximum Plasma Concentration (Cmax) of CCK

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 7

  36. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 7

  37. Area Under the Curve (AUC) of CCK

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 14

  38. Maximum Plasma Concentration (Cmax) of CCK

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 14

  39. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 14

  40. Area Under the Curve (AUC) of CCK

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 21

  41. Maximum Plasma Concentration (Cmax) of CCK

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: Day 21

  42. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 21

  43. Area Under the Curve (AUC) of CCK

    Area Under the Curve (AUC) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 28

  44. Maximum Plasma Concentration (Cmax) of CCK

    Maximum Plasma Concentration (Cmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 28

  45. Time of Maximum Plasma Concentration (Tmax) of CCK

    Time of Maximum Plasma Concentration (Tmax) of CCK (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 28

  46. Area Under the Curve (AUC) of Grehlin

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  47. Maximum Plasma Concentration (Cmax) of Grehlin

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: Day 0

  48. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  49. Area Under the Curve (AUC) of Grehlin

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  50. Maximum Plasma Concentration (Cmax) of Grehlin

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 7

  51. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  52. Area Under the Curve (AUC) of Grehlin

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  53. Maximum Plasma Concentration (Cmax) of Grehlin

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  54. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  55. Area Under the Curve (AUC) of Grehlin

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  56. Maximum Plasma Concentration (Cmax) of Grehlin

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  57. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  58. Area Under the Curve (AUC) of Grehlin

    Area Under the Curve (AUC) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  59. Maximum Plasma Concentration (Cmax) of Grehlin

    Maximum Plasma Concentration (Cmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  60. Time of Maximum Plasma Concentration (Tmax) of Grehlin

    Time of Maximum Plasma Concentration (Tmax) of Grehlin (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  61. Area Under the Curve (AUC) of leptin

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 0

  62. Maximum Plasma Concentration (Cmax) of leptin

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  63. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  64. Area Under the Curve (AUC) of leptin

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  65. Maximum Plasma Concentration (Cmax) of leptin

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 7

  66. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  67. Area Under the Curve (AUC) of leptin

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  68. Maximum Plasma Concentration (Cmax) of leptin

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  69. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  70. Area Under the Curve (AUC) of leptin

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  71. Maximum Plasma Concentration (Cmax) of leptin

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  72. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  73. Area Under the Curve (AUC) of leptin

    Area Under the Curve (AUC) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  74. Maximum Plasma Concentration (Cmax) of leptin

    Maximum Plasma Concentration (Cmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  75. Time of Maximum Plasma Concentration (Tmax) of leptin

    Time of Maximum Plasma Concentration (Tmax) of leptin (defined in ng/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  76. Area Under the Curve (AUC) of GLP1

    Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 0

  77. Maximum Plasma Concentration (Cmax) of GLP1

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 0

  78. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  79. Area Under the Curve (AUC) of GLP1

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 7

  80. Maximum Plasma Concentration (Cmax) of GLP1

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 7

  81. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  82. Area Under the Curve (AUC) of GLP1

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  83. Maximum Plasma Concentration (Cmax) of GLP1

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  84. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  85. Area Under the Curve (AUC) of GLP1

    Area Under the Curve (AUC) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  86. Maximum Plasma Concentration (Cmax) of GLP1

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  87. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  88. Area Under the Curve (AUC) of GLP1

    Area Under the Curve (AUC) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  89. Maximum Plasma Concentration (Cmax) of GLP1

    Maximum Plasma Concentration (Cmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  90. Time of Maximum Plasma Concentration (Tmax) of GLP1

    Time of Maximum Plasma Concentration (Tmax) of GLP1 (defined in pmol /L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  91. Area Under the Curve (AUC) of incretines

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 0

  92. Maximum Plasma Concentration (Cmax) of incretines

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  93. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  94. Area Under the Curve (AUC) of incretines

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  95. Maximum Plasma Concentration (Cmax) of incretines

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  96. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 7

  97. Area Under the Curve (AUC) of incretines

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  98. Maximum Plasma Concentration (Cmax) of incretines

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  99. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  100. Area Under the Curve (AUC) of incretines

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  101. Maximum Plasma Concentration (Cmax) of incretines

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  102. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  103. Area Under the Curve (AUC) of incretines

    Area Under the Curve (AUC) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  104. Maximum Plasma Concentration (Cmax) of incretines

    Maximum Plasma Concentration (Cmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  105. Time of Maximum Plasma Concentration (Tmax) of incretines

    Time of Maximum Plasma Concentration (Tmax) of incretines (defined in pg/mL) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  106. Area Under the Curve (AUC) of insulin

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 0

  107. Maximum Plasma Concentration (Cmax) of insulin

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 0

  108. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  109. Area Under the Curve (AUC) of insulin

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  110. Maximum Plasma Concentration (Cmax) of insulin

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  111. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 7

  112. Area Under the Curve (AUC) of insulin

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  113. Maximum Plasma Concentration (Cmax) of insulin

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  114. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  115. Area Under the Curve (AUC) of insulin

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  116. Maximum Plasma Concentration (Cmax) of insulin

    Maximum Plasma Concentration (Cmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  117. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  118. Area Under the Curve (AUC) of insulin

    Area Under the Curve (AUC) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  119. Maximum Plasma Concentration (Cmax) of urea

    Maximum Plasma Concentration (Cmax) of urea (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  120. Time of Maximum Plasma Concentration (Tmax) of insulin

    Time of Maximum Plasma Concentration (Tmax) of insulin (defined in µg/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  121. Area Under the Curve (AUC) of urea

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 0

  122. Maximum Plasma Concentration (Cmax) of urea

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 0

  123. Time of Maximum Plasma Concentration (Tmax) of urea

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 0

  124. Area Under the Curve (AUC) of urea

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  125. Maximum Plasma Concentration (Cmax) of urea

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 7

  126. Time of Maximum Plasma Concentration (Tmax) of urea

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 7

  127. Area Under the Curve (AUC) of urea

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  128. Maximum Plasma Concentration (Cmax) of urea

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 14

  129. Time of Maximum Plasma Concentration (Tmax) of urea

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 14

  130. Area Under the Curve (AUC) of urea

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  131. Maximum Plasma Concentration (Cmax) of urea

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 21

  132. Time of Maximum Plasma Concentration (Tmax) of urea

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 21

  133. Area Under the Curve (AUC) of urea

    Area Under the Curve (AUC) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  134. Maximum Plasma Concentration (Cmax) of urea

    Maximum Plasma Concentration (Cmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste.

    Measured: day 28

  135. Time of Maximum Plasma Concentration (Tmax) of urea

    Time of Maximum Plasma Concentration (Tmax) of urea (defined in mmol/L) between T0 and T120 minutes following ingestion of fruit paste

    Measured: day 28

  136. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 0 after ingestion in Day 0

  137. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

    Measured: at time 60 after ingestion in Day 0

  138. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 180 after ingestion in Day 0

  139. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

    Measured: at time 0 after ingestion in Day 7

  140. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

    Measured: at time 60 after ingestion in Day 7

  141. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 180 after ingestion in Day 7

  142. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 0 after ingestion in Day 14

  143. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

    Measured: at time 60 after ingestion in Day 14

  144. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry

    Measured: at time 180 after ingestion in Day 14

  145. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 0 after ingestion in Day 21

  146. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 60 after ingestion in Day 21

  147. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 180 after ingestion in Day 21

  148. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 0 after ingestion in Day 28

  149. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 60 after ingestion in Day 28

  150. Questionnaire of satiety

    Questionnaire was composed of 4 questions where satiety was assessed by a 0-10 Numerical Satiety Rating Scale where "0" means to be free from hunger and "10" to be very hungry.

    Measured: at time 180 after ingestion in Day 28

  151. Questionnaire of acceptability

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

    Measured: day 0

  152. Questionnaire of acceptability

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

    Measured: day 7

  153. Questionnaire of acceptability

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

    Measured: day 14

  154. Questionnaire of acceptability

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

    Measured: day 21

  155. Questionnaire of acceptability

    Acceptability was assessed by a 7-point time scale where "1" means a very poor acceptability and "7" means a very good acceptability

    Measured: day 28

  156. Facilited individual interview

    Facilitated interview to assess organoleptic, satiety and gastrointestinal comfort

    Measured: day 40

  157. Focus group

    Focus group interview to assess organoleptic, satiety and gastrointestinal comfort

    Measured: day 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2020
  2. Study start31 May 2021
  3. Primary completion15 Jul 2021
  4. Study completion19 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04482530
Sponsor's protocol ID
RBHP 2019 PICKERING
Other IDs
2019-A00995-52
Acronym
Fruisenior
Status last verified
Sep 2022
First submitted
16 Jun 2020
Last updated
27 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing fruit paste matrice in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve (AUC) of glycemia (time frame: Day 0). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04482530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.

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