Weight Regain After Consumption of Food Supplement and Interventional Diet Program

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.

Official Title
-----------------
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

Conditions
-----------------
Obesity, Overweight, Weight Loss, Body Weight Changes, Weight Change, Body

Intervention / Treatment
-----------------
* Dietary Supplement: Fat-binder damm
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental product : FAT-BINDER DAMM<br>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. | Dietary Supplement: Fat-binder damm<br>* 3 sticks every day during 12 months<br>|
| Placebo Comparator: Control product : PLACEBO<br>3 sticks of the dietary supplement (1.4grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. | Dietary Supplement: Placebo<br>* 3 sticks every day during 12 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Regain | Change from baseline in kilograms | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (weight/height^2) | Change from baseline in kg/m^2 | 12 months | 
| Fat mass percentage | Change from baseline in percentage | 12 months | 
| Body water percentage | Change from baseline in percentage | 12 months | 
| Lean mass percentage | Change from baseline in percentage | 12 months | 
| Triglycerides | Change from baseline | 12 months | 
| Low density lipoprotein cholesterol | Change from baseline | 12 months | 
| High density lipoprotein cholesterol | Change from baseline | 12 months | 
| Fiber | Change from baseline | 12 months | 
| Satiety evaluation | Visual Analog Scale to evaluate motivation-satiety when eating | [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. | 
| 24 hours Dietary Recall | 24 hours Food habits of overweight and obesity people | 12 months | 
| Sensory perception | Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness. | Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products. | 
| International Physical Activity Questionnaire | People physical activity habits | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Weight Loss, Body weight maintenance, Weight Change, Body, Saccharomyces Cerevisiae, Beta-glucans, Overweight