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

NCT ID: NCT05104151

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2021-07-27

Brief 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

Keywords

protein; weight control; appetite; overweight and obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group with nutritional bar

Participants will recieve two nutritional bars per day during eight weeks, and will receive a healthy habits intervention wich includes: nutritional intervention providing a caloric deficit of 500 calories, and a prescription of moderate physical activity from 60 to 90 minutes daily.

Group Type: EXPERIMENTAL

Nutritional bar

Intervention Type: DIETARY_SUPPLEMENT

Protein-based nutritional bar, providing 155 calories per bar

Healthy Habits Intervention

Intervention Type: BEHAVIORAL

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.

Group without nutritional bar

Participants will receive a healthy habits intervention wich includes nutritional intervention providing a caloric deficit of 500 calories, and a prescription of moderate physical activity from 60 to 90 minutes daily during eight weeks.

Group Type: ACTIVE_COMPARATOR

Healthy Habits Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Nutritional bar

Protein-based nutritional bar, providing 155 calories per bar

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Overweight or obesity (BMI range between 25.0 and 35 kg per m2 and
• Percentage of fat ≥28 for women and ≥20 for men

Exclusion Criteria

• Pregnant
• People with gastrointestinal, thyroid, renal, hepatic or cardiovascular diseases.
• Diabetics or hypertensive.
• People with eating disorders.
• Use of anti-obesity drugs in the last 4 weeks.
• Use of nutritional or medicinal anti-obesity supplements in the last 4 weeks.
• Celiac Disease.
• Allergies to peanuts, nines, eggs, milk or products derived from milk.
• Vegans.
• Physical or mental disability.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CES University

OTHER

Sponsor Role: lead

Responsible Party

Uriel Palacios

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uriel Palacios, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

CES University

Medellín, Antioquia, Colombia

Countries

Colombia

Other Identifiers

668

Identifier Type: -

Identifier Source: org_study_id