Overweight or Obesity Clinical Trial
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
NCT number | NCT05104151 |
Other study ID # | 668 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 20, 2017 |
Est. completion date | July 27, 2021 |
Verified date | October 2021 |
Source | CES University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 27, 2021 |
Est. primary completion date | June 13, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Colombia | CES University | Medellín | Antioquia |
Lead Sponsor | Collaborator |
---|---|
CES University |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Difference in body weight | The subjects will be weighed by means of a balance SECA 813 | 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 | |
Secondary | 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. | These levels will be measured over two days over the course of week one of the study for both groups | |
Secondary | 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 | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06013163 -
A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03843424 -
Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers
|
N/A | |
Not yet recruiting |
NCT06360536 -
Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women
|
N/A | |
Not yet recruiting |
NCT05997576 -
A Study of TG103 Injection in Non-diabetic Overweight or Obesity
|
Phase 3 | |
Recruiting |
NCT04763291 -
Cardiovascular and InflammAging Study
|
N/A | |
Active, not recruiting |
NCT04399460 -
The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
|
N/A | |
Completed |
NCT04451824 -
Examination of Circumferential Reduction
|
N/A | |
Completed |
NCT04110717 -
Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body Weight
|
N/A | |
Completed |
NCT05561855 -
T2DM Intensity Lifestyle Intervention
|
N/A | |
Active, not recruiting |
NCT04100200 -
Berries, Inflammation, and Gut Microbiome
|
N/A | |
Recruiting |
NCT06125964 -
eMOTION Formative Study
|
N/A | |
Recruiting |
NCT06087822 -
Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®
|
N/A | |
Active, not recruiting |
NCT04328233 -
Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome
|
N/A | |
Completed |
NCT06091761 -
Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity
|
N/A | |
Completed |
NCT04894344 -
Education to Decrease in Sodium Intake Evaluated With 24 Hour Urinary Sodium Excretion (RCT)
|
N/A | |
Completed |
NCT05713461 -
Physical Exercise in Obesity for Health and Quality of Life.
|
N/A | |
Not yet recruiting |
NCT06054698 -
Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects
|
Phase 2 | |
Not yet recruiting |
NCT02823912 -
Capsaicin Effect on Cytokines Profile in Dyslipidemia
|
Phase 2/Phase 3 | |
Completed |
NCT04786925 -
Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations
|
N/A | |
Enrolling by invitation |
NCT06092632 -
Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults
|
N/A |