NCT03554525CompletedPhase 3
Clinical Trial to Evaluate the Usefulness of the Regular Consumption of a Food Supplement(FAT-BINDER DAMM) on Weight Regain After an Interventional Diet Program on Overweight/Obese People
Instituto de Investigación Hospital Universitario La Paz1 site in 1 country120 target enrollmentStarted: April 1, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Weight Regain
Study Overview
Brief Summary
Effect of the dietary supplement (FAT-BINDER DAMM) on weight regain after 9 months of control weight program
Detailed Description
- 60 participants will consume experimental product every day 3 sticks of the dietary supplement (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the 12 first weeks, each volunteer will be included on a low weight program (PPP) with an individual hypocaloric diet planning and regular physical adapted activity (PPP period). When PPP period is over, volunteers will continue consuming the product for 9 months more (Post-PPP period).
- 60 participants will consume everyday 3 placebo sticks (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the first 12 weeks, each volunteer will be included on a low weight program (PPP) with an individual hypocaloric diet planning and regular physical adapted activity (PPP period ). When PPP period is over, volunteers will continue consuming the product for 9 months more.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women ranging from 18 to 65 years old.
- •BMI ≥27 and <40 kg/m
- •Overweight type II, obesity type I and II
- •Social or familiar environment that prevents from accomplishing the dietary treatment.
- •Willingness to follow a balanced hypocaloric diet in order to lose weight and perform regular physical adapted activity.
- •Adequate cultural level and understanding of the clinical trial.
- •Signed informed consent.
Exclusion Criteria
- •Individuals diagnosed with Diabetes Mellitus type I.
- •Individuals diagnosed with Diabetes Mellitus type II on pharmacological treatment.
- •Individuals with dyslipidemia on pharmacological treatment.
- •Individuals with hypertension on pharmacological treatment uncontrolled.
- •Individuals allergic to yeast.
- •Individuals with chronic diseases (hepatic, kidney…).
- •Individuals who have participated in the last 6 months in a program or clinical trial to lose weight.
- •Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ADOs).
- •Pregnant or breastfeeding women.
Arms & Interventions
Experimental product : FAT-BINDER DAMM
Experimental
3 sticks of the dietary supplement (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.
Intervention: Fat-binder damm (Dietary Supplement)
Control product : PLACEBO
Placebo Comparator
3 sticks of the dietary supplement (1.4grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Weight Regain
Time Frame: 12 months
Change from baseline in kilograms
Secondary Outcomes
- Sensory perception(Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.)
- Lean mass percentage(12 months)
- Fat mass percentage(12 months)
- High density lipoprotein cholesterol(12 months)
- Satiety evaluation([Just before eating the product; Just after eating; After 60 minutes; After 90 minutes] Fasting for at least 4 hours. Must do it with a snack accompanied and 500 ml water.)
- Low density lipoprotein cholesterol(12 months)
- 24 hours Dietary Recall(12 months)
- Body Mass Index (weight/height^2)(12 months)
- Body water percentage(12 months)
- Triglycerides(12 months)
- Fiber(12 months)
- International Physical Activity Questionnaire(12 months)
Investigators
Study Sites (1)
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