An interventional study of Nutritional bar and Healthy Habits Intervention in Overweight or Obesity, sponsored by CES University. Completed at 1 site in Colombia. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by CES University · Not applicable, Interventional, and Treatment
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.
Primary objective and outcome: Difference in body fat percentage and summation of the absolute value of 7 body folds
Secondary objectives and outcomes:
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
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
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
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.
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).
Time frame: 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
Difference in body weight
The subjects will be weighed by means of a balance SECA 813
Time frame: 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.
The level of appetite after consumption of the food will be evaluated using an analogue visual scale (AVE). The AVE for appetite ranges from "0" (least appetite) to 10 (maximum appetite or hunger) and will be printed on sheets that will be delivered to the participants on the day of their nutritional evaluation and also by email, in case the lose Participants will be asked to either consume the product for group A or the isocaloric food recommended by the nutritionist for group B for two moments in the day (mid-morning or second feeding of the day and during the mid-afternoon or the fourth meal of the day), the subjects will be asked to write in the format the time of food intake, then the subjects must complete the EVA appetite scale every half hour for 2 hours. write by text message to the researchers the time of food consumption, so that they remind participants to fill out the form every 30 minutes.
Time frame: 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
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, the 7 body folds will be (triceps, biceps, subscapular, abdominal, supraspinal, anterior thigh and middle leg), and then will be made the summation of the absolute value of these 7 body folds
Time frame: 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
Plan to share: Undecided — IPD will not be shared because the privacy of the participants will be guaranteed by not divulging their names in the scientific study process, or publication.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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CES University