NCT03636217

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

August 16, 2018

Last Update Submit

October 31, 2020

Conditions

Keywords

AppetiteProbioticGlycemic index

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Subsequent energy consumption

    Energy intake at ad libitum lunch was calculated.

    Three hours after the test breakfast

Secondary Outcomes (9)

  • Desiring for sweet

    Three hours postprandial period

  • Desiring for salty

    Three hours postprandial period

  • Desiring for savoury

    Three hours postprandial period

  • Desiring for fatty

    Three hours postprandial period

  • Visual appeal of test meal

    Immediately after consuming test meal (at 15 min)

  • +4 more secondary outcomes

Study Arms (3)

LGI-Milk Breakfast

EXPERIMENTAL

Low glycemic index and milk content (LGI-Milk) breakfast as a test meal

Other: LGI-Milk Breakfast

LGI-Kefir Breakfast

EXPERIMENTAL

Low glycemic index and kefir content (LGI-Kefir) breakfast as a test meal

Other: LGI-Kefir Breakfast

HGI-Kefir Breakfast

EXPERIMENTAL

High glycemic index and kefir content (HGI-Kefir) breakfast as a test meal

Other: HGI-Kefir Breakfast

Interventions

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-Milk Breakfast

In crossover design, this test meal with low glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast.

LGI-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.

HGI-Kefir Breakfast

Eligibility Criteria

Age21 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Normal-weight (BMI 18.5-25 kg/m2)
  • Female
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Health Sciences

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 17, 2018

Study Start

November 15, 2016

Primary Completion

March 15, 2017

Study Completion

May 31, 2017

Last Updated

November 3, 2020

Record last verified: 2020-10

Locations