Weight Regain After Consumption of Food Supplement and Interventional Diet Program

Instituto de Investigación Hospital Universitario La Paz120 enrolled

Overview

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

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Obesity Overweight Weight Loss Body Weight Changes Weight Change, Body

Interventions

Fat-binder dammDIETARY_SUPPLEMENT

3 sticks every day during 12 months

PlaceboDIETARY_SUPPLEMENT

3 sticks every day during 12 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Institute for Health Research IdiPAZ

Madrid, Spain

Outcomes

Primary Outcomes

Weight Regain

Change from baseline in kilograms

Time frame: 12 months

Secondary Outcomes

Body Mass Index (weight/height^2)

Change from baseline in kg/m\^2

Time frame: 12 months

Fat mass percentage

Change from baseline in percentage

Time frame: 12 months

Body water percentage

Change from baseline in percentage

Time frame: 12 months

Lean mass percentage

Change from baseline in percentage

Time frame: 12 months

Triglycerides

Change from baseline

Time frame: 12 months

Low density lipoprotein cholesterol

Change from baseline

Time frame: 12 months

High density lipoprotein cholesterol

Change from baseline

Time frame: 12 months

Fiber

Change from baseline

Time frame: 12 months

Satiety evaluation

Visual Analog Scale to evaluate motivation-satiety when eating

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.