NCT03554525

Weight Regain After Consumption of Food Supplement and Interventional Diet Program

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Overweight
• Weight Loss
• Body Weight Changes
• Weight Change, Body

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fat-binder damm	3 sticks every day during 12 months
DIETARY_SUPPLEMENT	Placebo	3 sticks every day during 12 months

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2018-06-13
• Last updated: 2019-04-17

Locations

1 site across 1 country: Spain