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CompletedNCT03554525fat-binderUpdated Apr 17, 2019

Weight Regain After Consumption of Food Supplement and Interventional Diet Program

A Phase 3 interventional study of Fat-binder damm and Placebo in Obesity, Overweight and Weight Loss, sponsored by Instituto de Investigación Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Instituto de Investigación Hospital Universitario La Paz · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Apr 2017, registered Apr 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

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

Keywords

  • Obesity
  • Overweight
  • Weight Loss
  • Body weight maintenance
  • Weight Change, Body
  • Saccharomyces Cerevisiae
  • Beta-glucans
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 120 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 100 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementFat-binder damm

    3 sticks every day during 12 months

  • Dietary supplementPlacebo

    3 sticks every day during 12 months

06

What researchers measure

Primary outcomes

  1. Weight Regain

    Change from baseline in kilograms

    Time frame: 12 months

Secondary outcomes

  1. Body Mass Index (weight/height^2)

    Change from baseline in kg/m\^2

    Time frame: 12 months

  2. Fat mass percentage

    Change from baseline in percentage

    Time frame: 12 months

  3. Body water percentage

    Change from baseline in percentage

    Time frame: 12 months

  4. Lean mass percentage

    Change from baseline in percentage

    Time frame: 12 months

  5. Triglycerides

    Change from baseline

    Time frame: 12 months

  6. Low density lipoprotein cholesterol

    Change from baseline

    Time frame: 12 months

  7. High density lipoprotein cholesterol

    Change from baseline

    Time frame: 12 months

  8. Fiber

    Change from baseline

    Time frame: 12 months

  9. Satiety evaluation

    Visual Analog Scale to evaluate motivation-satiety when eating

    Time frame: [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.

  10. 24 hours Dietary Recall

    24 hours Food habits of overweight and obesity people

    Time frame: 12 months

  11. Sensory perception

    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.

    Time frame: Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.

  12. International Physical Activity Questionnaire

    People physical activity habits

    Time frame: 12 months

07

Study locations

1 site
  • Institute for Health Research IdiPAZ
    Madrid, 28046, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03554525
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Responsible party
Sponsor
First posted
Jun 13, 2018
Start date
Apr 1, 2017
Primary completion
Dec 1, 2018
Completion
Dec 1, 2018
Last update
Apr 17, 2019

Study contacts

Carmen Gómez Candela, PhD, MS
principal investigator · Hospital Universitario La Paz

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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