Appetitive BehaviorNCT03636217
Effect of Kefir on Appetite
A study testing LGI-Milk Breakfast, LGI-Kefir Breakfast and HGI-Kefir Breakfast in people with Appetitive Behavior, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- LGI-Milk Breakfast, LGI-Kefir Breakfast and HGI-Kefir Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2016to 31 May 2017
- 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 21 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Normal-weight (BMI 18.5-25 kg/m2)
- Female
- 21-24 years
Who cannot join
- 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
Show all 10Show fewer
- Having difficulties with swallowing/eating
- Lack of appetite
- Hypersensitivity for the foods understudy
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Health Sciences
Kayseri, 38039
About this study
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.
- Conditions
- Appetitive Behavior
- Being tested
- LGI-Milk Breakfast, LGI-Kefir Breakfast, HGI-Kefir Breakfast
- Keywords
- Appetite, Probiotic, Glycemic index
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGI-Milk BreakfastOther
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.
LGI-Kefir BreakfastOther
In crossover design, this test meal with low glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast.
HGI-Kefir BreakfastOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LGI-Milk Breakfast | Experimental | Low glycemic index and milk content (LGI-Milk) breakfast as a test meal Receives: Other: LGI-Milk Breakfast |
| LGI-Kefir Breakfast | Experimental | Low glycemic index and kefir content (LGI-Kefir) breakfast as a test meal Receives: Other: LGI-Kefir Breakfast |
| HGI-Kefir Breakfast | Experimental | High glycemic index and kefir content (HGI-Kefir) breakfast as a test meal Receives: Other: HGI-Kefir Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger rating
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.
Measured: Three hours postprandial period
Fullness rating
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.
Measured: Three hours postprandial period
Desiring to eat
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.
Measured: Three hours postprandial period
Prospective food consumption
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.
Measured: Three hours postprandial period
Composite appetite score
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.
Measured: Three hours postprandial period
Subsequent energy consumption
Energy intake at ad libitum lunch was calculated.
Measured: Three hours after the test breakfast
Secondary outcomes (9)
Desiring for sweet
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.
Measured: Three hours postprandial period
Desiring for salty
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.
Measured: Three hours postprandial period
Desiring for savoury
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.
Measured: Three hours postprandial period
Desiring for fatty
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.
Measured: Three hours postprandial period
Visual appeal of test meal
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.
Measured: Immediately after consuming test meal (at 15 min)
Smell of test meal
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.
Measured: Immediately after consuming test meal (at 15 min)
Taste of test meal
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.
Measured: Immediately after consuming test meal (at 15 min)
Aftertaste of test meal
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.
Measured: Immediately after consuming test meal (at 15 min)
Palatability of test meal
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.
Measured: Immediately after consuming test meal (at 15 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Nov 2016
- Primary completion15 Mar 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Caferoglu, PhD, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636217
- Sponsor's protocol ID
- not defined
- Status last verified
- Oct 2020
- First submitted
- 16 Aug 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kefir on Appetite
- ClinicalTrials.gov ID
- NCT03636217
- Acronym / sponsor ID
- not defined
- Conditions
- Appetitive Behavior
- Keywords
- Appetite, Probiotic, Glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LGI-Milk Breakfast | Experimental | Other: LGI-Milk BreakfastLow glycemic index and milk content (LGI-Milk) breakfast as a test meal |
| LGI-Kefir Breakfast | Experimental | Other: LGI-Kefir BreakfastLow glycemic index and kefir content (LGI-Kefir) breakfast as a test meal |
| HGI-Kefir Breakfast | Experimental | Other: HGI-Kefir BreakfastHigh glycemic index and kefir content (HGI-Kefir) breakfast as a test meal |
Who may qualify
- Ages
- 21 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Normal-weight (BMI 18.5-25 kg/m2)
- Female
- 21-24 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LGI-Milk BreakfastThis 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. | Other | LGI-Milk Breakfast |
| LGI-Kefir BreakfastIn crossover design, this test meal with low glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast. | Other | LGI-Kefir Breakfast |
| HGI-Kefir BreakfastIn 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. | Other | HGI-Kefir Breakfast |
Primary outcome
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.
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.
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.
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.
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.
Subsequent energy consumption
Time frame: Three hours after the test breakfast
Energy intake at ad libitum lunch was calculated.
9 secondary outcomes
Desiring for sweet
Time frame: Three hours postprandial period
Desiring for salty
Time frame: Three hours postprandial period
Desiring for savoury
Time frame: Three hours postprandial period
Desiring for fatty
Time frame: Three hours postprandial period
Visual appeal of test meal
Time frame: Immediately after consuming test meal (at 15 min)
Smell of test meal
Time frame: Immediately after consuming test meal (at 15 min)
Taste of test meal
Time frame: 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 meal
Time frame: Immediately after consuming test meal (at 15 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LGI-Milk Breakfast, LGI-Kefir Breakfast and HGI-Kefir Breakfast in people with Appetitive Behavior, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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 3 Nov 2020. 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 Turkey (Türkiye). 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?
Hunger rating (time frame: Three hours postprandial period). The study lists 6 primary outcomes in all. 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 3 Nov 2020.