- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05581862
Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women
October 13, 2022 updated by: Eastern Mediterranean University
Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women Having Medical Nutrition Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Famagusta, Cyprus, 99450
- Eastern Mediterranean University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3 Meals+3 Snacks
This group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals and 3 snacks
|
All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals and 3 snacks for 3 months
|
Experimental: 3 Meals
This group was followed up for 3 months with an energy restricted weight loss plan composed of 3 main meals
|
All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in BMI (kg/m2)
Time Frame: 3 months
|
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)
Time Frame: 3 months
|
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)
Time Frame: 3 months
|
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 (%)
Time Frame: 3 months
|
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 (%)
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Müjgan Öztürk, PhD, Eastern Mediterranean University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
October 5, 2022
First Submitted That Met QC Criteria
October 13, 2022
First Posted (Actual)
October 17, 2022
Study Record Updates
Last Update Posted (Actual)
October 17, 2022
Last Update Submitted That Met QC Criteria
October 13, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/21-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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