- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05069506
Effects of Goat Milk Yogurt on Postprandial Glycemic Responses, Arterial Blood Pressure and Energy Intake
September 24, 2021 updated by: Aimilia Papakonstantinou, Agricultural University of Athens
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
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Athens, Greece, 11855
- Agricultural University of Athens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glucose as reference food
Twelve 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.
|
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.
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.
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.
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.
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.
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.
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.
|
|
Experimental: Goat milk as test food
Twelve 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.
|
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.
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.
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.
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.
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.
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.
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.
|
|
Experimental: Goat milk and currants as test food
Twelve 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.
|
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.
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.
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.
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.
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.
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.
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.
|
|
Experimental: Currants as test food
Twelve 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.
|
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.
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.
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.
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.
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.
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.
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.
|
|
Experimental: Sultanina raisins as test food
Twelve 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.
|
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.
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.
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.
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.
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.
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.
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.
|
|
Experimental: Goat milk as preload
Forty-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).
|
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.
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.
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.
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.
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.
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.
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.
|
|
Experimental: Milk with lactic acid as preload
Forty-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).
|
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.
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.
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.
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capillary blood glucose
Time Frame: 7 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite ratings
Time Frame: 7 hours
|
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
|
|
Energy intake after preload
Time Frame: 6 hours
|
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
|
|
Arterial blood pressure
Time Frame: 7 hours
|
Clinically useful change in systolic and diastolic blood pressure (mmHg) before and after consumption of test foods
|
7 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2019
Primary Completion (Actual)
July 9, 2019
Study Completion (Actual)
July 9, 2019
Study Registration Dates
First Submitted
July 9, 2019
First Submitted That Met QC Criteria
September 24, 2021
First Posted (Actual)
October 6, 2021
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
September 24, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRBD 24 Session 04/04/2019 NHA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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