Weight Regain After Consumption of Food Supplement and Interventional Diet Program (fat-binder)

Instituto de Investigación Hospital Universitario La Paz

Status and phase

Completed

Phase 3

Conditions

Weight Loss

Overweight

Obesity

Body Weight Changes

Weight Change, Body

Treatments

Dietary Supplement: Fat-binder damm

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

4801

Details and patient eligibility

About

Effect of the dietary supplement (FAT-BINDER DAMM) on weight regain after 9 months of control weight program

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men and women ranging from 18 to 65 years old.
BMI ≥27 and <40 kg/m2. 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.