Body Weight Changes, Obesity, Overweight, Weight Change, Body, Weight Loss
Conditions
Keywords
Obesity, Overweight, Weight Loss, Body weight maintenance, Weight Change, Body, Saccharomyces Cerevisiae, Beta-glucans
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.
Interventions
DIETARY_SUPPLEMENTFat-binder damm
3 sticks every day during 12 months
DIETARY_SUPPLEMENTPlacebo
3 sticks every day during 12 months
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Regain | 12 months | Change from baseline in kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass percentage | 12 months | Change from baseline in percentage |
| Body water percentage | 12 months | Change from baseline in percentage |
| Lean mass percentage | 12 months | Change from baseline in percentage |
| Triglycerides | 12 months | Change from baseline |
| Low density lipoprotein cholesterol | 12 months | Change from baseline |
| Body Mass Index (weight/height^2) | 12 months | Change from baseline in kg/m\^2 |
| Fiber | 12 months | Change from baseline |
| Satiety evaluation | [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. | Visual Analog Scale to evaluate motivation-satiety when eating |
| 24 hours Dietary Recall | 12 months | 24 hours Food habits of overweight and obesity people |
| Sensory perception | Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products. | 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 | 12 months | People physical activity habits |
| High density lipoprotein cholesterol | 12 months | Change from baseline |
Countries
Spain
Outcome results
None listed