Weight Regain After Consumption of Food Supplement and Interventional Diet Program

Phase 3

Completed

• Conditions: Weight Loss; Weight Change, Body; Obesity; Body Weight Changes; Overweight
• Interventions: Dietary Supplement: Fat-binder damm; Dietary Supplement: Placebo

• Registration Number: NCT03554525
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-13
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental product : FAT-BINDER DAMM	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.
Control product : PLACEBO	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.

Primary Outcome Measures

Name	Time	Method
Weight Regain	12 months	Change from baseline in kilograms

Secondary Outcome Measures

Name	Time	Method
24 hours Dietary Recall	12 months	24 hours Food habits of overweight and obesity people
Fiber	12 months	Change from baseline
International Physical Activity Questionnaire	12 months	People physical activity habits
High density lipoprotein cholesterol	12 months	Change from baseline
Low density lipoprotein cholesterol	12 months	Change from baseline
Lean mass percentage	12 months	Change from baseline in percentage
Fat mass percentage	12 months	Change from baseline in percentage
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
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.
Body Mass Index (weight/height^2)	12 months	Change from baseline in kg/m\^2
Body water percentage	12 months	Change from baseline in percentage
Triglycerides	12 months	Change from baseline

Trial Locations

Locations (1)

Institute for Health Research IdiPAZ; 🇪🇸 Madrid, Spain