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AzTrials

Insulin ResistanceGLYMICARENCT07408479

Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance

A study testing Balanced diet high in Slowly Digestible Starch and Resistant Starch and Balanced diet low in Slowly Digestible Starch and Resistant Starch in people with Insulin Resistance, run by Mondelēz International, Inc. at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To study the potential impact of a diet rich in both Slowly Digestible Starch (SDS) and Resistant Starch (RS), we propose a 2-month nutritional intervention study in which we will study the evolution of carbohydrate variability and metabolism and health-related parameters in 40 volunteers with insulin resistance. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Resistance
What is being tested?
Balanced diet high in Slowly Digestible Starch and Resistant Starch and Balanced diet low in Slowly Digestible Starch and Resistant Starch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteFrance
Study dates
15 Nov 2025to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • General criteria:
  • Age between 18 and 75 years (bounds included)
  • HOMA-IR ≥ 2.5
  • Body Mass Index (BMI) between 25 and 40 kg/m² (bounds included)
  • Stable weight over the past 3 months (+/- 5% of body weight)
  • Waist circumference > 80 cm for women, > 94 cm for men
Show all 17Show fewer
  • Sedentary subject or subject practising regular and stable physical activity for the duration of the study (maximum 4 hours per week)
  • Able to understand the provided information and having signed the informed consent forms
  • Able to read and write in French
  • Having a freezer and comfortable with storing stool samples at home
  • Having undergone a prior medical examination during the screening visit
  • Food-related criteria:
  • Willing to modify their diet for 2 months
  • No food intolerances or allergies
  • Regular consumption of the study products
  • Fiber intake ≤ 25 g/day
  • Willing to consume three main meals with no more than one snack per day and to take meals or snacks at least two hours apart

Who cannot join

  • General criteria:
  • Adult under legal protection (guardianship or curatorship)
  • Person with unstable medical or psychological conditions that, according to the investigator, could lead to non-compliance or non-cooperation during the study or compromise safety or participation (as per Articles L.1121-6, L.1121-8, L.1121-9, and L.1122-1-2 of the French Public Health Code)
  • Presence of a condition identified during clinical examination or medical interview that could interfere with study evaluations, as judged by the investigator
  • Person deprived of liberty by judicial or administrative decision
  • Failure to comply with the exclusion period of another study as indicated in the "national volunteer database"
Show all 45Show fewer
  • Person exceeding the annual compensation limit for participation in research protocols
  • Tobacco (or vaping equivalent) consumption > 5 cigarettes per day and inability to abstain from smoking or vaping from the evening prior to exploration days specified in the protocol
  • Alcoholism or alcohol abuse (> 30 g/day). Consuming more than three alcoholic drinks per day is considered abusive. One alcoholic drink corresponds to 30 mL of spirits, 120 mL of wine, or 330 mL of beer or abuse or dependency on another drug
  • Person not affiliated with a social security system or benefiting from a similar scheme
  • Absence of valid, approved health certificates in the event of government measures during an exceptional epidemic situation
  • Biological criteria:
  • Fasting blood glucose ≥ 7 mmol/L or ≥ 1.26 g/L
  • Triglycerides > 4 g/L
  • LDL-cholesterol > 1.90 g/L
  • eGRF (estimated glomerular filtration rate) < 60 ml/min
  • Other biological abnormality with significant clinical relevance according to the investigator
  • Population-related criteria :
  • Person with a specific dietary regimen (vegetarian, lacto-vegetarian, vegan, high-protein, low-carbohydrates, weight-loss diet, etc.)
  • Person consuming dietary supplements (prebiotics, probiotics, or minerals such as divalent cations like magnesium and calcium) regularly in the month before the selection visit and during the study
  • Blood donation within 2 months prior to the selection visit
  • Claustrophobia preventing indirect calorimetry measurement
  • Limited venous access making blood sampling and catheter placement difficult
  • Therapeutic and medical criteria:
  • Type 1 or Type 2 diabetes
  • Systolic blood pressure ≥ 140 mmHg
  • Diastolic blood pressure ≥ 90 mmHg
  • Hypertension treatment
  • Known endocrine pathology interfering with carbohydrate metabolism (uncontrolled thyroid dysfunction, acromegaly, hypercortisolism, etc.)
  • Gastrointestinal diseases with an inflammatory component or associated with malabsorption or considered likely to interfere with the results of the study;
  • History of bloody diarrhea
  • Exocrine pancreatic insufficiency
  • History of bariatric surgery
  • History of digestive surgery, except appendectomy and simple hernia repair
  • Severe eating disorders (e.g., anorexia, bulimia, binge-eating disorder, night-eating syndrome) as judged by the investigator;
  • Hepatocellular insufficiency
  • Immunosuppressed individuals (e.g., those with AIDS, lymphoma, long-term corticosteroid therapy, chemotherapy, or allogeneic transplant)
  • Central venous catheter carriers and post-surgical patients
  • Any other clinically significant unstable or untreated abnormality in the immunological, neoplastic, endocrine, hematological, gastrointestinal, hepatic, neurological, or psychiatric domains, as judged by the investigator
  • Obesity medication use within the past 3 months or during the study
  • Antibiotic use in the month prior to explorations (for common beta-lactam antibiotics) or within 3 months before explorations (for other antibiotics), as judged by the investigator
  • Daily laxative use within the 3 months prior to explorations or other medications significantly interfering with gut microbiota composition;
  • Use of treatments that could interfere with study measurements, as judged by the study's co-investigating physicians
  • Pregnant, planning to become pregnant (verified by a blood pregnancy test), or breastfeeding woman
  • Person with known allergy to adhesive materials

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julie-Anne Nazare, PhD contact

+33 4 78 86 29 81

julie-anne.nazare@univ-lyon1.fr

Alexandra Meynier, PhD contact

+33 1 83 11 45 68

alexandra.meynier@mdlz.com

France1 site, 1 recruiting

  • Centre de Recherche en Nutrition Humaine Rhone-Alpes

    Lyon, 69310

    Anne-Laure Castell, MD, +33 4 78 86 19 72, anne-laure.castell@chu-lyon.fr

    Maeliss Chisbert, MSc, ext-maeliss.chisbert@chu-lyon.fr

    Recruiting

Other trials in France

About this study

To study the potential impact of a diet rich in both Slowly Digestible Starch (SDS) and Resistant Starch (RS), we propose a 2-month nutritional intervention study in which we will study the evolution of carbohydrate variability and metabolism and health-related parameters in 40 volunteers with insulin resistance. Regular sampling of blood, urine and faeces as well as continuous measurement of blood glucose levels will be performed to assess changes in blood glucose levels, insulin resistance, lipid metabolism, inflammation and the composition of the microbiota following the introduction of starch products rich in SDS and RS into the diet.

Being tested
Balanced diet high in Slowly Digestible Starch and Resistant Starch, Balanced diet low in Slowly Digestible Starch and Resistant Starch
Keywords
Slowly Digestible Starch, SDS, Resistant Starch, Insulin resistant subjets, Glycemic control, Continuous Glucose Monitoring System, CGMS, Diet, Mean Amplitude of Glucose Excursion, microbiota
Medical subject headings
Insulin Resistance

What participants receive

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

  • Balanced diet high in Slowly Digestible Starch and Resistant StarchOther

    Also called Diet A, H-SDS-RS

    Diet where all the starchy foods were selected based on their SDS and RS content. This diet needs to be easy to apply by subjects. It will be consumed during 2 months

  • Balanced diet low in Slowly Digestible Starch and Resistant StarchOther

    Also called Diet B, L-SDS-RS

    Diet where all the starchy foods were selected based on their SDS and RS content. This diet needs to be easy to apply by subjects. It will be consumed during 2 months

Study groups in NCT07408479
Study groupRoleWhat they receive
High SDS-RS dietActive comparatorBalanced diet containing high levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)
Receives: Other: Balanced diet high in Slowly Digestible Starch and Resistant Starch
Low SDS-RS dietPlacebo comparatorBalanced diet containing low levels of Slowly digestible Starch (SDS) and Resistant Starch (RS)
Receives: Other: Balanced diet low in Slowly Digestible Starch and Resistant Starch

What is being measured

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

  1. Change in MAGE measured on 3 occasions between diets High or Low in SDS and RS

    Mean Amplitude of Glucose Excursions (MAGE) from CGMS record

    Measured: Evaluations done before, after 1 week and after 2 months on a diet

Secondary outcomes (57)

  1. Glycemia iAUC after a standard challenge test (FlexMeal) during the first metabolic day

    iAUC of postprandial glycemia

    Measured: 5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

  2. Insulin iAUC after a standard challenge test (FlexMeal) during the first metabolic day

    iAUC of postprandial insulinemia

    Measured: 5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

  3. GLP-1 iAUC after a standard challenge test (FlexMeal) during the first metabolic day

    GLP-1 iAUC

    Measured: 5 hours post standard challenge test during visit 2 (before starting nutritional intervention)

  4. Inflammatory status comparison during the first metabolic day : CRP concentration

    C-Reactive Protein (CRP)

    Measured: At baseline during V2 (before starting nutritional intervention)

  5. Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : TNFa iAUC

    iAUC of TNFa

    Measured: 5 hours post challenge test during visit 2 (before starting nutritional intervention)

  6. Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : IL6 iAUC

    iAUC of Interleukin 6 (IL-6)

    Measured: 5 hours post challenge test during visit 2(before starting nutritional intervention)

  7. Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day (V2) : IL1Ra iAUC

    iAUC of Interleukin-1 Receptor a (IL1Ra)

    Measured: 5 hours post challenge test during visit 2 (before starting nutritional intervention)

  8. Inflammatory impacts after a standard challenge test (FlexMeal) during the first metabolic day : IL18 iAUC

    iAUC of Interleukin-18 (IL-18)

    Measured: 5 hours post challenge test during visit 2 (before starting nutritional intervention)

  9. Glycemic impacts comparison following the intake of a diet either high or low in SDS and RS

    Glycemia concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  10. Insulinemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study

    Insulin concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  11. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : CRPus concentration

    CRPus

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  12. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : TNFa concentration

    TNFa concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  13. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL6 concentration

    IL6 concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  14. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL1Ra concentration

    IL1Ra concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  15. Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL18 concentration

    IL18 concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  16. Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : MDA concentration

    Malondialdehyde (MDA) concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  17. Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : Urinary isoprostanes concentration

    Urinary isoprostanes

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  18. Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sICAM concentration

    sICAM concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  19. Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sVCAM concentration

    sVCAM concentration

    Measured: In fasting state during visits V2, V4 and V6 (before and after 4 and 8 weeks of nutritional intervention)

  20. Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day

    Glycamia iAUC

    Measured: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  21. Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day

    Insulin iAUC

    Measured: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  22. GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day

    GLP1 iAUC

    Measured: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  23. Inflammatory impacts comparison following 2 months of intake of a diet either high or low in SDS : CRPus concentration

    CRPus concentration

    Measured: In fasting state during visit 6 (after 8 weeks of nutritional intervention)

  24. Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : TNFa iAUC

    TNFa iAUC

    Measured: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  25. Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL6 iAUC

    IL6 iAUC

    Measured: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  26. Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL1Ra iAUC

    IL1Ra iAUC

    Measured: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  27. Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL18 iAUC

    IL18 iAUC

    Measured: 5 hours post standard challenge test during visit 6 (after 8 weeks of nutritional intervention)

  28. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MAGE

    Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at Visit 1, Visit 3 and Visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  29. Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : TIR

    Time In Range (TIR) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, Visit 3 or visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  30. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CV

    Coefficient of Variation (CV) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  31. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : SD

    Standard Deviation (SD) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  32. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MIME

    Mean Indices of Meal Excursions (MIME) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  33. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MODD

    Mean Of Daily Differences (MODD) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  34. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CONGA

    Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  35. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : ADRR

    Average Daily Risk Range (ADRR) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  36. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : LGBI

    Low Blood Glucose Index (LGBI) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  37. Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : HGBI

    High Blood Glucose Index (HGBI) from CGMS glycaemia

    Measured: minimum 3 days to a maximum of 6 days of CGMS record starting at visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  38. Mean daylong incremental Area Under the Curve (iAUC) of glycemia, measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study

    The iAUC of glycemia will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored.

    Measured: from 0 minutes to 360 minutes postprandial during the CGMS record periods starting on visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  39. Mean daylong total Area Under the Curve (tAUC) of glycemia, measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study

    The tAUC will be calculated using the trapezoid rule

    Measured: from 0 minutes to 360 minutes postprandial during the CGMS record periods starting on visit 1, visit 3 and visit 5 (before, after 3 and 7 weeks of nutritional intervention)

  40. Diabetes follow-up markers : HbA1c

    HbA1c concentration

    Measured: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  41. Diabetes follow-up markers : Fructosamine concentration

    Fructosamine concentration

    Measured: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  42. Diabetes follow-up markers : Glycated Albumin concentration

    Glycated albumin concentration

    Measured: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  43. Anthropometry parameters

    Height

    Measured: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  44. Antropometry parameters : body weight

    body weight

    Measured: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  45. Anthropometric parameters : waist circumference

    waist circumference

    Measured: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  46. Athropometric parameters : hip circumference

    hip circumference

    Measured: In fasting state, during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  47. Body composition parameters characterisation : total body water

    Total body water measured by bioimpedancemetry

    Measured: In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  48. Body composition parameters characterisation : body fat

    Body fat measured by bioimpedancemetry

    Measured: In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  49. Body composition parameters characterisation : lean mass

    Lean mass measured by bioimpedancemetry

    Measured: In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  50. Resting energy metabolism profile : Resting Metabolism Rate

    Resting Metabolism Rate (RMR) measured by indirect calorimetry

    Measured: In fasting state, during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  51. Exhaled gases - Dihydrogen

    Dihydrogen measured during breath test

    Measured: Measured at time 0, 60, 120, 180, 240 minutes of breath test during visit 1 and visit 5 ((before and after 7 weeks of nutritional intervention)

  52. Exhaled gases - Methane

    Methane measured during breath test

    Measured: Measured at time 0, 60, 120, 180, 240 minutes of breath test during visit 1 and visit 5 (before and after 7 weeks of nutritional intervention)

  53. Exhaled gases : Volatile Organic Compounds

    Volatile Organic Compounds

    Measured: Measured at time T-30 minutes of breath test during visit 2 and visit 6 (before and after 8 weeks of nutritional intervention)

  54. Gut microbiota composition

    Whole genome shotgun sequencing

    Measured: Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  55. Microbiota activity : short chain fatty acids

    Short chain fatty acids measured in fecal samples

    Measured: Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  56. Microbiota functionlity

    Bacterial enzymes measured in feces

    Measured: Measured on samples collected at visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

  57. Level of physical activity characterisation following the intake of a diet either high or low in SDS during the time course of the study : IPAQ

    International Physical Activity Questionnaire (IPAQ)

    Measured: Evaluated at the arrival in the laboratory during visit 2, visit 4 and visit 6 (before and after 4 and 8 weeks of nutritional intervention)

Timeline

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

  1. First posted13 Feb 2026
  2. Study start15 Nov 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionJul 2028 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a single blind, randomized, controlled 2 months intervention study with parallel design
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408479
Sponsor's protocol ID
KBE072 / Glymicare
Acronym
GLYMICARE
Status last verified
Feb 2026
First submitted
19 Jan 2026
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Balanced diet high in Slowly Digestible Starch and Resistant Starch and Balanced diet low in Slowly Digestible Starch and Resistant Starch in people with Insulin Resistance, run by Mondelēz International, Inc. 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 17 inclusion and 45 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Julie-Anne Nazare, PhD (+33 4 78 86 29 81, julie-anne.nazare@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in MAGE measured on 3 occasions between diets High or Low in SDS and RS (time frame: Evaluations done before, after 1 week and after 2 months on a diet). 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 NCT07408479.

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 13 Feb 2026.

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