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Potential Abnormality of Glucose ToleranceNCT05069506

Effects of Goat Milk Yogurt on Postprandial Glycemic Responses, Arterial Blood Pressure and Energy Intake

A study testing Glucose as reference food, Goat milk as test food and Goat milk and currants as test food in people with Potential Abnormality of Glucose Tolerance and Appetite; Lack or Loss, Nonorganic Origin, run by Agricultural University of Athens at 1 site in Greece.

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

This study investigated any potential associations between two preloads offered as snacks and postprandial glycemic response, subjective appetite and energy intake in healthy, normal weight adults Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Glucose as reference food, Goat milk as test food and Goat milk and currants as test food
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteGreece
Study dates
6 Apr 2019to 9 Jul 2019
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy, non-smoking, non-diabetic men and women individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2)

Who cannot join

  • Severe chronic disease (e.g. tumors, manifest coronary heart disease, diabetes mellitus, severe kidney or liver conditions, endocrine and immunological conditions)
  • Gastrointestinal disorders (e.g. chronic inflammatory bowel disease)
  • Lactose intolerance
  • Pregnancy
  • Competitive sports
  • Lactation
  • Alcohol
  • Drug dependency

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Agricultural University of Athens

    Athens, 11855

Other trials in Greece

About this study

Official title: Short-term Effects of Goat Milk Yogurt on Postprandial Glycemic Responses, Arterial Blood Pressure, Energy Intake and Satiety

This study investigated any potential associations between two preloads offered as snacks and postprandial glycemic response, subjective appetite and energy intake in healthy, normal weight adults

Read the detailed description

This study aimed at 1. firstly determine the glycemic index (GI) of a) goat milk yogurt b) goat milk yogurt with currants, c) currants and d) sultanina raisins, all containing 25 gr available carbohydrates and 2. test the hypothesis that a goat milk yogurt consumed as a snack before a meal, compared to milk with lactic acid would: a) have greater short-term effect on satiety measured by subsequent ad libitum meal intake, b) induce greater satiety as assessed by visual analogue scales (VAS) and c) reduce postprandial glycemic response.

Being tested
Glucose as reference food, Goat milk as test food, Goat milk and currants as test food, Currants as test food, Sultanina raisins as test food

What participants receive

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

  • Glucose as reference foodOther

    Twelve subjects (male: 4 female: 8) consumed 25g glucose diluted in 150ml water, two times, in different weeks, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

  • Goat milk as test foodOther

    Twelve subjects (male: 4 female: 8) consumed 617 g goat milk yogurt, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

  • Goat milk and currants as test foodOther

    Twelve subjects (male: 4 female: 8) consumed 308 g goat milk yogurt and 19 g currants, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

  • Currants as test foodOther

    Twelve subjects (male: 4 female: 8) consumed 37.8 g currants, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

  • Sultanina raisins as test foodOther

    Twelve subjects (male: 4 female: 8) consumed 37.5 g sultanina raisins, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

  • Goat milk yogurt as preloadOther

    Forty-five healthy subjects (male: 12, female: 33) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (200g goat milk yogurt). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate vanilla cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.

  • Milk with lactic acid as preloadOther

    Forty-five healthy subjects (male: 12, female: 33) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (200g milk with lactic acid). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate vanilla cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.

Study groups in NCT05069506
Study groupRoleWhat they receive
Glucose as reference foodExperimentalTwelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Receives: Other: Glucose as reference food; Other: Goat milk as test food; Other: Goat milk and currants as test food; Other: Currants as test food; Other: Sultanina raisins as test food; Other: Goat milk yogurt as preload; Other: Milk with lactic acid as preload
Goat milk as test foodExperimentalTwelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Receives: Other: Glucose as reference food; Other: Goat milk as test food; Other: Goat milk and currants as test food; Other: Currants as test food; Other: Sultanina raisins as test food; Other: Goat milk yogurt as preload; Other: Milk with lactic acid as preload
Goat milk and currants as test foodExperimentalTwelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Receives: Other: Glucose as reference food; Other: Goat milk as test food; Other: Goat milk and currants as test food; Other: Currants as test food; Other: Sultanina raisins as test food; Other: Goat milk yogurt as preload; Other: Milk with lactic acid as preload
Currants as test foodExperimentalTwelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Receives: Other: Glucose as reference food; Other: Goat milk as test food; Other: Goat milk and currants as test food; Other: Currants as test food; Other: Sultanina raisins as test food; Other: Goat milk yogurt as preload; Other: Milk with lactic acid as preload
Sultanina raisins as test foodExperimentalTwelve healthy, normal-weight subjects (male: 4, female: 8) after 10-14 hr fast, consumed 25g available carbohydrate from glucose, three times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from a) goat milk yogurt, b) goat milk yogurt and currants, c) currants, d) sultanina raisins, one time each, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Receives: Other: Glucose as reference food; Other: Goat milk as test food; Other: Goat milk and currants as test food; Other: Currants as test food; Other: Sultanina raisins as test food; Other: Goat milk yogurt as preload; Other: Milk with lactic acid as preload
Goat milk as preloadExperimentalForty-five healthy subjects (male: 12, female: 33) were offered a standardized breakfast and 2h after consumed one of the two preloads (goat milk yogurt and milk with lactic acid) served as snack in random order. Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). Foods were weighed at the time of serving and any leftovers were weighed again after meal to determine the amount of food consumed. Fingertip capillary blood glucose samples were collected before and after foods. Subjective appetite ratings were collected using 100mm visual analogue scales (VAS).
Receives: Other: Glucose as reference food; Other: Goat milk as test food; Other: Goat milk and currants as test food; Other: Currants as test food; Other: Sultanina raisins as test food; Other: Goat milk yogurt as preload; Other: Milk with lactic acid as preload
Milk with lactic acid as preloadExperimentalForty-five healthy subjects (male: 12, female: 33) were offered a standardized breakfast and 2h after consumed one of the two preloads (goat milk yogurt and milk with lactic acid) served as snack in random order. Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). Foods were weighed at the time of serving and any leftovers were weighed again after meal to determine the amount of food consumed. Fingertip capillary blood glucose samples were collected before and after foods. Subjective appetite ratings were collected using 100mm visual analogue scales (VAS).
Receives: Other: Glucose as reference food; Other: Goat milk as test food; Other: Goat milk and currants as test food; Other: Currants as test food; Other: Sultanina raisins as test food; Other: Goat milk yogurt as preload; Other: Milk with lactic acid as preload

What is being measured

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

  1. Capillary blood glucose

    Clinically useful change in serum glucose (mg/dL), defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test and for a total of 5 hours

    Measured: 7 hours

Secondary outcomes (3)
  1. Subjective appetite ratings

    Useful change in subjective appetite (hunger, desire to eat, motivation to eat, preoccupation with thoughts of food, thirst) scores 0 up to 10 from 100mm Visual Analogue Scales

    Measured: 7 hours

  2. Energy intake after preload

    Useful change in energy intake (kcal) the day of the intervention (actual weighing of foods in grams consumed and leftovers using a Kern \& Sohn (Germany) food weight scale (Max 3500 g, d=0.01g) and analysis from 24hr recalls using Diet Analysis Software

    Measured: 6 hours

  3. Arterial blood pressure

    Clinically useful change in systolic and diastolic blood pressure (mmHg) before and after consumption of test foods

    Measured: 7 hours

Timeline

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

  1. First posted6 Oct 2021
  2. Study start6 Apr 2019
  3. Primary completion9 Jul 2019
  4. Study completion9 Jul 2019

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Other: Glucose as reference food Other: goat milk yogurt as test food Other: goat milk yogurt with currants as test food Other: currants as test food Other: sultanina raisins as test food Other: goat milk preload Other: milk with lactic acid preload
Masking
Single blind
Who is masked
Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05069506
Sponsor's protocol ID
HRBD 24 Session 04/04/2019 NHA
Status last verified
Sep 2021
First submitted
9 Jul 2019
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
Yes
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 Glucose as reference food, Goat milk as test food and Goat milk and currants as test food in people with Potential Abnormality of Glucose Tolerance and Appetite; Lack or Loss, Nonorganic Origin, run by Agricultural University of Athens at 1 site in Greece.

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 1 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 6 Oct 2021. 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 Greece. 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?

Capillary blood glucose (time frame: 7 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Oct 2021.

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