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Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
3 meals+3 snacks
3 meals
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Meal Frequency, body composition, BMI, waist circumference

Eligibility Criteria

19 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 19-64 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

Exclusion Criteria:

  • Failure to meet the criteria for inclusion

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3 Meals+3 Snacks

3 Meals

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in BMI (kg/m2)
Both of the groups had a significant change in BMI, but there was no difference among the groups
Change in Waist circumference (cm)
Both of the groups had a significant change in waist circumference, but there was no difference among the groups
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
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
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

Secondary Outcome Measures

Full Information

First Posted
October 5, 2022
Last Updated
October 13, 2022
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT05581862
Brief Title
Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women
Official Title
Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women Having Medical Nutrition Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study was conducted with 40 female volunteers between the ages of 19-64 years, with a Body Mass Index (BMI) ≥27. Energy restricted individualized weight loss programs were applied with different meal frequencies (3 meals+3 snacks/day vs 3 meals/day) in a 3 month follow up period. 20 participants were randomized in 3 meals+3 snacks and 20 participants were randomized in 3 meals group. Food consumption was questioned, and anthropometric measurements and body composition were measured before the study and repeated each week till the end of the study. Three day food records (2 week days and 1 weekend day) taken before the intervention were evaluated and five hundred calorie was subtracted from the average energy calculated form the food records to determine the energy of the weight loss plans . Breakfast, lunch and dinner are planned as main meals and the beverages and/or food eaten between main meals were planned as snacks (50-200 kcal). For both of the groups dietary weight loss program was planned by the same dietitian. Macronutrient composition of the weight loss plan was designed according to the recommendations of the Turkish Dietary Guidelines as 45-60 % carbohydrate, 10-20 % protein and 20-35 % fat for both of the groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Meal Frequency, body composition, BMI, waist circumference

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 Meals+3 Snacks
Arm Type
Experimental
Arm Description
This group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals and 3 snacks
Arm Title
3 Meals
Arm Type
Experimental
Arm Description
This group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals
Intervention Type
Behavioral
Intervention Name(s)
3 meals+3 snacks
Intervention Description
All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals and 3 snacks for 3 months
Intervention Type
Behavioral
Intervention Name(s)
3 meals
Intervention Description
All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals for 3 months
Primary Outcome Measure Information:
Title
Change in BMI (kg/m2)
Description
Both of the groups had a significant change in BMI, but there was no difference among the groups
Time Frame
3 months
Title
Change in Waist circumference (cm)
Description
Both of the groups had a significant change in waist circumference, but there was no difference among the groups
Time Frame
3 months
Title
Change in total body fat (kg)
Description
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
Time Frame
3 months
Title
Change in body fat percentage (%)
Description
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
Time Frame
3 months
Title
Change in fat free mass percentage (%)
Description
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
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 19-64 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 Exclusion Criteria: Failure to meet the criteria for inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Müjgan Öztürk, PhD
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Study Director
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
ZIP/Postal Code
99450
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women

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