Weight Regain After Consumption of Food Supplement and Interventional Diet Program (fat-binder)
Primary Purpose
Obesity, Overweight, Weight Loss
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Fat-binder damm
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Weight Loss, Body weight maintenance, Weight Change, Body, Saccharomyces Cerevisiae, Beta-glucans
Eligibility Criteria
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:
- 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.
Sites / Locations
- Institute for Health Research IdiPAZ
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental product : FAT-BINDER DAMM
Control product : PLACEBO
Arm Description
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.
3 sticks of the dietary supplement (1.4grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.
Outcomes
Primary Outcome Measures
Weight Regain
Change from baseline in kilograms
Secondary Outcome Measures
Body Mass Index (weight/height^2)
Change from baseline in kg/m^2
Fat mass percentage
Change from baseline in percentage
Body water percentage
Change from baseline in percentage
Lean mass percentage
Change from baseline in percentage
Triglycerides
Change from baseline
Low density lipoprotein cholesterol
Change from baseline
High density lipoprotein cholesterol
Change from baseline
Fiber
Change from baseline
Satiety evaluation
Visual Analog Scale to evaluate motivation-satiety when eating
24 hours Dietary Recall
24 hours Food habits of overweight and obesity people
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.
International Physical Activity Questionnaire
People physical activity habits
Full Information
NCT ID
NCT03554525
First Posted
April 6, 2018
Last Updated
April 16, 2019
Sponsor
Instituto de Investigación Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT03554525
Brief Title
Weight Regain After Consumption of Food Supplement and Interventional Diet Program
Acronym
fat-binder
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental product : FAT-BINDER DAMM
Arm Type
Experimental
Arm Description
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.
Arm Title
Control product : PLACEBO
Arm Type
Placebo Comparator
Arm Description
3 sticks of the dietary supplement (1.4grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fat-binder damm
Intervention Description
3 sticks every day during 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
3 sticks every day during 12 months
Primary Outcome Measure Information:
Title
Weight Regain
Description
Change from baseline in kilograms
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Body Mass Index (weight/height^2)
Description
Change from baseline in kg/m^2
Time Frame
12 months
Title
Fat mass percentage
Description
Change from baseline in percentage
Time Frame
12 months
Title
Body water percentage
Description
Change from baseline in percentage
Time Frame
12 months
Title
Lean mass percentage
Description
Change from baseline in percentage
Time Frame
12 months
Title
Triglycerides
Description
Change from baseline
Time Frame
12 months
Title
Low density lipoprotein cholesterol
Description
Change from baseline
Time Frame
12 months
Title
High density lipoprotein cholesterol
Description
Change from baseline
Time Frame
12 months
Title
Fiber
Description
Change from baseline
Time Frame
12 months
Title
Satiety evaluation
Description
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.
Title
24 hours Dietary Recall
Description
24 hours Food habits of overweight and obesity people
Time Frame
12 months
Title
Sensory perception
Description
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.
Title
International Physical Activity Questionnaire
Description
People physical activity habits
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, PhD, MS
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research IdiPAZ
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Weight Regain After Consumption of Food Supplement and Interventional Diet Program
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