Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite
Condition: Overweight or Obesity
MeSH terms: Obesity; Overweight; Body Weight
Study type: Interventional

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.
    

Intervention name(s): Nutritional bar; Healthy Habits Intervention
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Protein-based nutritional bar, providing 155 calories per bar; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The proposed study is a randomized, single-blind, single center, parallel study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: protein; weight control; appetite; overweight and obesity