Effect of Kefir on Appetite

Appetitive Behavior Clinical Trial

Official title:

Effect of Kefir on Appetite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636217
• Other study ID #: not defined
• Status: Completed
• Phase: N/A
• Start date: November 15, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: October 2020
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 31, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior

Intervention

Other:
• LGI-Milk Breakfast
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 Breakfast
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 Breakfast
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.

Locations

Country	Name	City	State
Turkey	Erciyes University Faculty of Health Sciences	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three hours postprandial period
Primary	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.	Three hours postprandial period
Primary	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.	Three hours postprandial period
Primary	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.	Three hours postprandial period
Primary	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.	Three hours postprandial period
Primary	Subsequent energy consumption	Energy intake at ad libitum lunch was calculated.	Three hours after the test breakfast
Secondary	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.	Three hours postprandial period
Secondary	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.	Three hours postprandial period
Secondary	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.	Three hours postprandial period
Secondary	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.	Three hours postprandial period
Secondary	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.	Immediately after consuming test meal (at 15 min)
Secondary	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.	Immediately after consuming test meal (at 15 min)
Secondary	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.	Immediately after consuming test meal (at 15 min)
Secondary	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.	Immediately after consuming test meal (at 15 min)
Secondary	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.	Immediately after consuming test meal (at 15 min)