Weight Regain After Consumption of Food Supplement and Interventional Diet Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-12-01

Brief Summary

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

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Detailed Description

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* 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.

Conditions

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Obesity Overweight Weight Loss Body Weight Changes Weight Change, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental product : FAT-BINDER DAMM

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.

Group Type EXPERIMENTAL

Fat-binder damm

Intervention Type DIETARY_SUPPLEMENT

3 sticks every day during 12 months

Control product : PLACEBO

3 sticks of the dietary supplement (1.4grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

3 sticks every day during 12 months

Interventions

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Fat-binder damm

3 sticks every day during 12 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

3 sticks every day during 12 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes