NCT05104151

Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite

Evaluation of the Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite, in Patients With Overweight or Obesity in the City of medellín, 2017

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CES University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of the trial is to measure the efficacy of a nutritive bar, in the reduction of weight, body fat and the control of appetite, in patients with overweight and obesity. It will be a randomized single-blind design conducted in 40 subjects.

Detailed description

Primary objective and outcome: Difference in body fat percentage and summation of the absolute value of 7 body folds Secondary objectives and outcomes: * Characterize demographically and clinically the population participating in the research study. * Determine the differences in body weight between the study groups. * Determine the median of minutes of appetite onset in each of the groups. Design: The proposed study is a randomized, single-blind, paralell, single center study. Number of subjects: The number of subjects will be 40. At the start of the study, subjects will be randomly assigned to 2 different groups. All participants will have a evaluation with a nutritionist for an anthropometric assessment that includes the measurement of percentage of fat, sum of body folds, weight, height and Body Mass Index. All participants will receive a nutritional intervention providing a caloric deficit of 500 calories, depending on their daily requirements,and they will be prescribed moderate physical activity from 60 to 90 minutes daily. Participants will then be randomly assigned to gruop A: the nutritional bar group or group B: Control. Participants in group A will be instructed to consume the nutritional bar as an integral part of the previously established caloric regimen so as not to increase the number of prescribed calories and will be instructed to consume the product twice a day during the whole study, approximately 2 to 4 hours after breakfast and 2 to 4 hours after lunch, without additions of other foods or beverages, during consumption, may only be accompanied with water. Participants in group B will be instructed to consume a nutritious snack corresponding to the amount of calories provided by the bar, 2 to 4 hours after breakfast and 2 to 4 hours after lunch. The nutritional intervention will be carried out for 8 weeks for both groups, during the forth week and during the eight week of the intervention, a new nutritional assessment will be carried out with the same protocol of the first evaluation, by a nutritionist to all participants.

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional bar	Protein-based nutritional bar, providing 155 calories per bar
BEHAVIORAL	Healthy Habits Intervention	The participants included, will receive a nutritional intervention providing a caloric deficit of 500 calories, depending on their daily requirements, these daily requirements calculated according to the formula BMR (Basic Metabolic Rate). Also prescription of moderate physical activity from 60 to 90 minutes daily will be made.

Timeline

• Start date: 2017-10-20
• Primary completion: 2021-06-13
• Completion: 2021-07-27
• First posted: 2021-11-02
• Last updated: 2021-11-02

Locations

1 site across 1 country: Colombia