Clinical trial NCT03554525: Weight Regain After Consumption of Food Supplement and Interventional Diet Program
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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Weight Regain
timeFrame: 12 months
Secondary outcomes:
measure: Body Mass Index (weight/height^2)
timeFrame: 12 months
measure: Fat mass percentage
timeFrame: 12 months
measure: Body water percentage
timeFrame: 12 months
measure: Lean mass percentage
timeFrame: 12 months
measure: Triglycerides
timeFrame: 12 months
measure: Low density lipoprotein cholesterol
timeFrame: 12 months
measure: High density lipoprotein cholesterol
timeFrame: 12 months
measure: Fiber
timeFrame: 12 months
measure: Satiety evaluation
timeFrame: [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.
measure: 24 hours Dietary Recall
timeFrame: 12 months
measure: Sensory perception
timeFrame: Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.
measure: International Physical Activity Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gómez Candela, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: