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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05069506
Other study ID # HRBD 24 Session 04/04/2019 NHA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 6, 2019
Est. completion date July 9, 2019

Study information

Verified date September 2021
Source Agricultural University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date July 9, 2019
Est. primary completion date July 9, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Healthy, non-smoking, non-diabetic men and women individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms

  • Anorexia
  • Appetite; Lack or Loss, Nonorganic Origin
  • Potential Abnormality of Glucose Tolerance

Intervention

Other:
Glucose as reference food
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 food
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 food
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 food
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 food
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 preload
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 preload
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.

Locations

Country Name City State
Greece Agricultural University of Athens Athens

Sponsors (1)

Lead Sponsor Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 7 hours
Secondary 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 7 hours
Secondary 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 6 hours
Secondary Arterial blood pressure Clinically useful change in systolic and diastolic blood pressure (mmHg) before and after consumption of test foods 7 hours
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