NCT05581862

Brief Summary

Studies showing the relationship between meal frequency, weight loss and anthropometric measurements are contradictory. This study is planned and conducted to observe the effects of meal frequency (3 meals+3 snacks vs 3 meals) on weight loss, anthropometric measurements and body composition with 3-month energy restricted Medical Nutrition Therapy program in 19-64 years old women with a BMI ≥ 27 kg/m2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

October 5, 2022

Last Update Submit

October 13, 2022

Conditions

Overweight and Obesity

Keywords

Meal Frequencybody compositionBMIwaist circumference

Outcome Measures

Primary Outcomes (5)

  • Change in BMI (kg/m2)

    Both of the groups had a significant change in BMI, but there was no difference among the groups

    3 months

  • Change in Waist circumference (cm)

    Both of the groups had a significant change in waist circumference, but there was no difference among the groups

    3 months

  • Change in total body fat (kg)

    Both of the groups had a significant change in total body fat however the rate of change in total body fat was significantly higher in 3 meals+3snacks group

    3 months

  • Change in body fat percentage (%)

    Both of the groups had a significant change in body fat percentage however the rate of change in body fat percentage was significantly higher in 3 meals+3snacks group

    3 months

  • Change in fat free mass percentage (%)

    Both of the groups had a significant change in fat free mass percentage, however the rate of change was significantly higher in 3 meals+3 snacks group

    3 months

Study Arms (2)

3 Meals+3 Snacks

EXPERIMENTAL

This group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals and 3 snacks

Behavioral: 3 meals+3 snacks

3 Meals

EXPERIMENTAL

This group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals

Behavioral: 3 meals

Interventions

3 meals+3 snacksBEHAVIORAL

All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals and 3 snacks for 3 months

3 Meals+3 Snacks
3 mealsBEHAVIORAL

All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals for 3 months

3 Meals

Eligibility Criteria

Age19 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old Women,
  • Healthy subjects with no chronic diseases,
  • Subjects who were not taking any drug or dietary supplements,
  • Subjects who have not made any changes in their physical activity or eating habits for weight loss in the last 6 months,
  • Subjects with a BMI ≥ 27 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

Location

Related Publications (1)

  • Otuken Koroglu Y, Ozturk M. Meal Frequency Does Not Affect Weight Loss in Overweight/Obese Women but Affects the Body Composition: A Randomized Controlled Trial. J Am Nutr Assoc. 2024 Aug;43(6):489-497. doi: 10.1080/27697061.2024.2316636. Epub 2024 Feb 13.

    PMID: 38349951DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Müjgan Öztürk, PhD

    Eastern Mediterranean University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 17, 2022

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 17, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CY(1)