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

Sponsor

Instituto de Investigación Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT03554525

Collaborator

(none)

120

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Weight Loss Body Weight Changes Weight Change, Body	Dietary Supplement: Fat-binder damm Dietary Supplement: Placebo	Phase 3

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

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Fat-binder damm 3 sticks every day during 12 months
Placebo Comparator: 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.	Dietary Supplement: Placebo 3 sticks every day during 12 months

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: Fat-binder damm

3 sticks every day during 12 months

Placebo Comparator: 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.

Dietary Supplement: Placebo

3 sticks every day during 12 months

Outcome Measures

Primary Outcome Measures

Weight Regain [12 months]
Change from baseline in kilograms

Secondary Outcome Measures

Body Mass Index (weight/height^2) [12 months]
Change from baseline in kg/m^2
Fat mass percentage [12 months]
Change from baseline in percentage
Body water percentage [12 months]
Change from baseline in percentage
Lean mass percentage [12 months]
Change from baseline in percentage
Triglycerides [12 months]
Change from baseline
Low density lipoprotein cholesterol [12 months]
Change from baseline
High density lipoprotein cholesterol [12 months]
Change from baseline
Fiber [12 months]
Change from baseline
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.]
Visual Analog Scale to evaluate motivation-satiety when eating
24 hours Dietary Recall [12 months]
24 hours Food habits of overweight and obesity people
Sensory perception [Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.]
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.
International Physical Activity Questionnaire [12 months]
People physical activity habits

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.