- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636217
Effect of Kefir on Appetite
October 31, 2020 updated by: Zeynep Caferoglu, PhD, TC Erciyes University
This study aimed to determine the effect of kefir on appetite in healthy subjects.
A randomized, single-blind, and 3-intervention crossover trial included 22 healthy and normal-weight (BMI 18.5-25 kg/m2) females aged 21-24 years.
Participants were recruited to three test meals: an LGI-Milk, an LGI-Kefir, and an HGI-Kefir, with a one-week washout period.
Appetite ratings were measured at 0, 15, 30, 60, 90, 120, 150, and 180 minutes.
At the end of three hours, participants were served an ad libitum lunch meal.
Then, the foods eaten at lunch were recorded and their energy and nutrient analysis was calculated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
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Kayseri, Turkey, 38039
- Erciyes University Faculty of Health Sciences
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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
21 years to 24 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy
- Normal-weight (BMI 18.5-25 kg/m2)
- Female
- 21-24 years
Exclusion Criteria:
- During the last three months, change more than 5 kg in body weight or following an energy-restricted diet
- Being a vegan
- Having any chronic diseases such as diabetes, hypertension, etc.
- Physician-diagnosed medications or conditions that influence metabolism
- Smoking
- Practicing endurance sports
- Having difficulties with swallowing/eating
- Lack of appetite
- Hypersensitivity for the foods understudy
- Pregnant or lactating
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: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LGI-Milk Breakfast
Low glycemic index and milk content (LGI-Milk) breakfast as a test meal
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This test meal with low glycemic index and milk were served as a breakfast after 12-hours fasting and participants were asked to consume the meal in full, within 15 min.
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Experimental: LGI-Kefir Breakfast
Low glycemic index and kefir content (LGI-Kefir) breakfast as a test meal
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In crossover design, this test meal with low glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast.
|
|
Experimental: HGI-Kefir Breakfast
High glycemic index and kefir content (HGI-Kefir) breakfast as a test meal
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In crossover design, this test meal with high glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast and the LGI-Kefir Breakfast.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hunger rating
Time Frame: Three hours postprandial period
|
Subjective assessment of appetite sensations was performed by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How hungry do you feel? (not at all hungry - as hungry as I ever felt)" at time points 0, 15, 30, 60, 90, 120, 150 and 180 minutes, and hunger rating was quantified as AUC (mm x min), which was calculated according to the trapezoidal rule by using those VAS scores.
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Three hours postprandial period
|
|
Fullness rating
Time Frame: Three hours postprandial period
|
Subjective assessment of appetite sensations was performed by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How full do you feel? (not at all full - totally full)" at time points 0, 15, 30, 60, 90, 120, 150 and 180 minutes, and fullness rating was quantified as AUC (mm x min), which was calculated according to the trapezoidal rule by using those VAS scores.
Total scale score changes in a range of 0-100.
Higher values represent a better outcome.
|
Three hours postprandial period
|
|
Desiring to eat
Time Frame: Three hours postprandial period
|
Subjective assessment of appetite sensations was performed by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How strong is your desire to eat? (very weak - very strong)" at time points 0, 15, 30, 60, 90, 120, 150 and 180 minutes, and desiring to eat was quantified as AUC (mm x min), which was calculated according to the trapezoidal rule by using those VAS scores.
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Three hours postprandial period
|
|
Prospective food consumption
Time Frame: Three hours postprandial period
|
Subjective assessment of appetite sensations was performed by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How much do you think you can eat?
(no food at all - a large amount of food)" at time points 0, 15, 30, 60, 90, 120, 150 and 180 minutes, and prospective food consumption was quantified as AUC (mm x min), which was calculated according to the trapezoidal rule by using those VAS scores.
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Three hours postprandial period
|
|
Composite appetite score
Time Frame: Three hours postprandial period
|
The separate visual analog scale factors like hunger, fullness, desiring for eat, and prospective food consumption were combined to produce an additional measure termed 'composite appetite score'.
This average appetite score was computed for 0, 15, 30, 60, 90, 120, 150 and 180 minutes using the following equation: [(hunger + desire to eat + prospective food consumption + (100 - fullness)]/4 Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Three hours postprandial period
|
|
Subsequent energy consumption
Time Frame: Three hours after the test breakfast
|
Energy intake at ad libitum lunch was calculated.
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Three hours after the test breakfast
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Desiring for sweet
Time Frame: Three hours postprandial period
|
Subjective assessment of desire for specific food types was performed by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "Would you like to eat something sweet?
(No, not at all - Yes, very much)" at time points 0, 15, 30, 60, 90, 120, 150 and 180 minutes, and desiring for sweet was quantified as AUC (mm x min), which was calculated according to the trapezoidal rule by using those VAS scores.
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Three hours postprandial period
|
|
Desiring for salty
Time Frame: Three hours postprandial period
|
Subjective assessment of desire for specific food types was performed by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "Would you like to eat something salty?
(No, not at all - Yes, very much)" at time points 0, 15, 30, 60, 90, 120, 150 and 180 minutes, and desiring for salty was quantified as AUC (mm x min), which was calculated according to the trapezoidal rule by using those VAS scores.
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Three hours postprandial period
|
|
Desiring for savoury
Time Frame: Three hours postprandial period
|
Subjective assessment of desire for specific food types was performed by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "Would you like to eat something savoury?
(No, not at all - Yes, very much)" at time points 0, 15, 30, 60, 90, 120, 150 and 180 minutes, and desiring for savoury was quantified as AUC (mm x min), which was calculated according to the trapezoidal rule by using those VAS scores.
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Three hours postprandial period
|
|
Desiring for fatty
Time Frame: Three hours postprandial period
|
Subjective assessment of desire for specific food types was performed by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "Would you like to eat something fatty?
(No, not at all - Yes, very much)" at time points 0, 15, 30, 60, 90, 120, 150 and 180 minutes, and desiring for fatty was quantified as AUC (mm x min), which was calculated according to the trapezoidal rule by using those VAS scores.
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Three hours postprandial period
|
|
Visual appeal of test meal
Time Frame: Immediately after consuming test meal (at 15 min)
|
Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How is the visual appeal of test meal?
(Good - Bad)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Immediately after consuming test meal (at 15 min)
|
|
Smell of test meal
Time Frame: Immediately after consuming test meal (at 15 min)
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Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How is the smell of test meal?
(Good - Bad)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
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Immediately after consuming test meal (at 15 min)
|
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Taste of test meal
Time Frame: Immediately after consuming test meal (at 15 min)
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Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How is the taste of test meal?
(Good - Bad)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Immediately after consuming test meal (at 15 min)
|
|
Aftertaste of test meal
Time Frame: Immediately after consuming test meal (at 15 min)
|
Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "Is there any perceived taste in your mouth after test meal?
(Much - None)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a better outcome.
|
Immediately after consuming test meal (at 15 min)
|
|
Palatability of test meal
Time Frame: Immediately after consuming test meal (at 15 min)
|
Palatability of test meals was measured by using a visual analog scale (VAS) composed of lines (of 100 mm in length) with words anchored at each end, expressing the most positive and the most negative rating.
VAS ratings were measured by using a question "How is the palatability of test meal?
(Good - Bad)" at time points 15 minutes (immediately after consuming test meal).
Total scale score changes in a range of 0-100.
Higher values represent a worse outcome.
|
Immediately after consuming test meal (at 15 min)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 15, 2016
Primary Completion (Actual)
March 15, 2017
Study Completion (Actual)
May 31, 2017
Study Registration Dates
First Submitted
August 16, 2018
First Submitted That Met QC Criteria
August 16, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
October 31, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- not defined
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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