Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03602001 - Attentive Eating for Weight Loss N/A
Recruiting NCT06269159 - The Power of 24-hour: Co-designing Intervention Components
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Completed NCT04647149 - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity N/A
Terminated NCT03914066 - A Group-based Treatment of Overweight and Obesity in Primary Care N/A
Completed NCT03685656 - Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers N/A
Completed NCT05051579 - A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities Phase 2
Completed NCT04611477 - Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals N/A
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Completed NCT03599115 - Effects of Inhibitory Control Training in Eating Behaviors N/A
Recruiting NCT05938894 - Train Your Brain - Executive Function N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Recruiting NCT05987306 - A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss N/A
Completed NCT03792685 - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention N/A
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Completed NCT04520256 - Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy Phase 2/Phase 3
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A