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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05581862
Other study ID # 2016/21-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date October 2015

Study information

Verified date October 2022
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Cyprus Eastern Mediterranean University Famagusta

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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