Weight Regain After Consumption of Food Supplement and Interventional Diet Program

Last updated: April 16, 2019
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Overall Status: Completed

Phase

3

Condition

Body Composition

Obesity

Weight Loss

Treatment

N/A

Clinical Study ID

NCT03554525
4801
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 performregular physical adapted activity.

  • Adequate cultural level and understanding of the clinical trial.

  • Signed informed consent.

Exclusion

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 trialto lose weight.

  • Individuals receiving at least the preceding 2 months a pharmacological treatment thatmodifies the lipid profile (for example, statins, fibrates, diuretics,corticosteroids, ADOs).

  • Pregnant or breastfeeding women.

Study Design

Total Participants: 120
Study Start date:
April 01, 2017
Estimated Completion Date:
December 01, 2018

Study 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.

Connect with a study center

  • Institute for Health Research IdiPAZ

    Madrid, 28046
    Spain

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.