NCT03554525

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

April 6, 2018

Last Update Submit

April 16, 2019

Conditions

ObesityOverweightWeight LossBody Weight ChangesWeight Change, Body

Keywords

ObesityOverweightWeight LossBody weight maintenanceWeight Change, BodySaccharomyces CerevisiaeBeta-glucans

Outcome Measures

Primary Outcomes (1)

  • Weight Regain

    Change from baseline in kilograms

    12 months

Secondary Outcomes (12)

  • Body Mass Index (weight/height^2)

    12 months

  • Fat mass percentage

    12 months

  • Body water percentage

    12 months

  • Lean mass percentage

    12 months

  • Triglycerides

    12 months

  • +7 more secondary outcomes

Study Arms (2)

Experimental product : FAT-BINDER DAMM

EXPERIMENTAL

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

Control product : PLACEBO

PLACEBO COMPARATOR

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

Interventions

Fat-binder dammDIETARY_SUPPLEMENT

3 sticks every day during 12 months

Experimental product : FAT-BINDER DAMM
PlaceboDIETARY_SUPPLEMENT

3 sticks every day during 12 months

Control product : PLACEBO

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

ObesityOverweightWeight LossBody Weight Changes

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carmen Gómez Candela, PhD, MS

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

June 13, 2018

Study Start

April 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 17, 2019

Record last verified: 2018-04

Locations

ES(1)