search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
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
Goat milk yogurt as preload
Milk with lactic acid as preload
Sponsored by
Agricultural University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Potential Abnormality of Glucose Tolerance

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Agricultural University of Athens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Goat milk as preload

Milk with lactic acid as preload

Arm Description

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 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 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 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 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.

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2019
Last Updated
September 24, 2021
Sponsor
Agricultural University of Athens
search

1. Study Identification

Unique Protocol Identification Number
NCT05069506
Brief Title
Effects of Goat Milk Yogurt on Postprandial Glycemic Responses, Arterial Blood Pressure and Energy Intake
Official Title
Short-term Effects of Goat Milk Yogurt on Postprandial Glycemic Responses, Arterial Blood Pressure, Energy Intake and Satiety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2019 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agricultural University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potential Abnormality of Glucose Tolerance, Appetite; Lack or Loss, Nonorganic Origin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Investigator
Masking Description
Single (Investigator)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose as reference food
Arm Type
Experimental
Arm Description
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.
Arm Title
Goat milk as test food
Arm Type
Experimental
Arm Description
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.
Arm Title
Goat milk and currants as test food
Arm Type
Experimental
Arm Description
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.
Arm Title
Currants as test food
Arm Type
Experimental
Arm Description
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.
Arm Title
Sultanina raisins as test food
Arm Type
Experimental
Arm Description
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.
Arm Title
Goat milk as preload
Arm Type
Experimental
Arm Description
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).
Arm Title
Milk with lactic acid as preload
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Glucose as reference food
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Goat milk as test food
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Goat milk and currants as test food
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Currants as test food
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sultanina raisins as test food
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Goat milk yogurt as preload
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Milk with lactic acid as preload
Intervention Description
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.
Primary Outcome Measure Information:
Title
Capillary blood glucose
Description
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
Time Frame
7 hours
Secondary Outcome Measure Information:
Title
Subjective appetite ratings
Description
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
Time Frame
7 hours
Title
Energy intake after preload
Description
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
Time Frame
6 hours
Title
Arterial blood pressure
Description
Clinically useful change in systolic and diastolic blood pressure (mmHg) before and after consumption of test foods
Time Frame
7 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Agricultural University of Athens
City
Athens
ZIP/Postal Code
11855
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs