ObesityPhase 3fat-binderNCT03554525
Weight Regain After Consumption of Food Supplement and Interventional Diet Program
A Phase 3 study testing Fat-binder damm in people with Obesity and Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Effect of the dietary supplement (FAT-BINDER DAMM) on weight regain after 9 months of control weight program Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Fat-binder damm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2017to 1 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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…).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Obesity, Overweight, Weight Loss, Body Weight Changes, Weight Change, Body
- Being tested
- Fat-binder damm, Placebo
- Keywords
- Obesity, Overweight, Weight Loss, Body weight maintenance, Weight Change, Body, Saccharomyces Cerevisiae, Beta-glucans
- Medical subject headings
- Obesity, Overweight, Weight Loss, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat-binder dammDietary supplement
3 sticks every day during 12 months
PlaceboDietary supplement
3 sticks every day during 12 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Regain
Change from baseline in kilograms
Measured: 12 months
Secondary outcomes (12)
Body Mass Index (weight/height^2)
Change from baseline in kg/m^2
Measured: 12 months
Fat mass percentage
Change from baseline in percentage
Measured: 12 months
Body water percentage
Change from baseline in percentage
Measured: 12 months
Lean mass percentage
Change from baseline in percentage
Measured: 12 months
Triglycerides
Change from baseline
Measured: 12 months
Low density lipoprotein cholesterol
Change from baseline
Measured: 12 months
High density lipoprotein cholesterol
Change from baseline
Measured: 12 months
Fiber
Change from baseline
Measured: 12 months
Satiety evaluation
Visual Analog Scale to evaluate motivation-satiety when eating
Measured: [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.
24 hours Dietary Recall
24 hours Food habits of overweight and obesity people
Measured: 12 months
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.
Measured: Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.
International Physical Activity Questionnaire
People physical activity habits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Apr 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, PhD, MS, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554525
- Sponsor's protocol ID
- 4801
- Acronym
- fat-binder
- Status last verified
- Apr 2018
- First submitted
- 6 Apr 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03554525
- Acronym / sponsor ID
- fat-binder / 4801
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental product : FAT-BINDER DAMM | Experimental | Dietary Supplement: Fat-binder damm3 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 comparator | Dietary Supplement: Placebo3 sticks of the dietary supplement (1.4grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat-binder damm3 sticks every day during 12 months | Dietary supplement | Experimental product : FAT-BINDER DAMM |
| Placebo3 sticks every day during 12 months | Dietary supplement | Control product : PLACEBO |
Primary outcome
Weight Regain
Time frame: 12 months
Change from baseline in kilograms
12 secondary outcomes
Body Mass Index (weight/height^2)
Time frame: 12 months
Fat mass percentage
Time frame: 12 months
Body water percentage
Time frame: 12 months
Lean mass percentage
Time frame: 12 months
Triglycerides
Time frame: 12 months
Low density lipoprotein cholesterol
Time frame: 12 months
High density lipoprotein cholesterol
Time frame: 12 months
Fiber
Time frame: 12 months
Satiety evaluation
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.
24 hours Dietary Recall
Time frame: 12 months
Sensory perception
Time frame: Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.
International Physical Activity Questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, PhD, MS principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fat-binder damm in people with Obesity and Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Regain (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.