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

NCT05104151 | Completed

• 1 other identifier: 668
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight or Obesity

Keywords

protein; weight control; appetite; overweight and obesity

Outcome Measures

Primary Outcomes (1)

• Difference in body fat percentage

  The difference in changes of corporal body fat will be measured by calculating the percentage of body fat and the summation of the absolute value of 7 body folds. The percentage of body fat will be determined by using the Siri equation (% Fat = 4.95 / Dc) - 4.50 x 100), the calculation of the body density by the Jackson and Pollock anthropometric equation Dc = 1.10938 - 0.0008267 (sum of three folds) + 0.0000016 (sum of three folds) 2 - 0.0002574 years), the body folds for this outcome will be performed according to the International Society for the Advancement of Cineanthropometry (ISAK) protocol, with the body adipometer Harpenden (In women: Triceps, supraspinal and anterior thigh) (in men: pectoral, abdomen and thigh).

  These measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant

Secondary Outcomes (3)

• Difference in body weight

  This measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant

• Determine the median of minutes of appetite onset in each of the groups.

  These levels will be measured over two days over the course of week one of the study for both groups

• Difference in summation of the absolute value of 7 body folds

  This measuremen will be made on: day one of study start for each particinat, during the fourth week of each participant of the study and during the eighth (last week) of the study for each participant

Study Arms (2)

Group with nutritional bar

EXPERIMENTAL

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.

Dietary Supplement: Nutritional bar; Behavioral: Healthy Habits Intervention

Group without nutritional bar

ACTIVE COMPARATOR

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.

Behavioral: Healthy Habits Intervention

Interventions

Nutritional bar DIETARY_SUPPLEMENT

Protein-based nutritional bar, providing 155 calories per bar

Group with nutritional bar

Healthy Habits Intervention 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 with nutritional bar; Group without nutritional bar

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CES University: lead

Study Sites (1)

CES University

Medellín, Antioquia, 050001, Colombia

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uriel Palacios, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The proposed study is a randomized, single-blind, single center, parallel study.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: October 20, 2017
• Primary Completion: June 13, 2021
• Study Completion: July 27, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

CO (1)