Clinical trial NCT05104151: Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obesity
Keywords: protein
weight control
appetite
overweight and obesity
Lead sponsor: CES University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study is a randomized, single-blind, single center, parallel study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difference in body fat percentage
timeFrame: 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:
measure: Difference in body weight
timeFrame: 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
measure: Determine the median of minutes of appetite onset in each of the groups.
timeFrame: These levels will be measured over two days over the course of week one of the study for both groups
measure: Difference in summation of the absolute value of 7 body folds
timeFrame: 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
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: CES University
state: Antioquia
Study officials:
affiliation: Professor
name: Uriel Palacios, MD
role: PRINCIPAL_INVESTIGATOR
References: