Weight Regain After Consumption of Food Supplement and Interventional Diet Program

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554525
• Other study ID #: 4801
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2018
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Fat-binder damm
3 sticks every day during 12 months
• Placebo
3 sticks every day during 12 months

Locations

Country	Name	City	State
Spain	Institute for Health Research IdiPAZ	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Regain	Change from baseline in kilograms	12 months
Secondary	Body Mass Index (weight/height^2)	Change from baseline in kg/m^2	12 months
Secondary	Fat mass percentage	Change from baseline in percentage	12 months
Secondary	Body water percentage	Change from baseline in percentage	12 months
Secondary	Lean mass percentage	Change from baseline in percentage	12 months
Secondary	Triglycerides	Change from baseline	12 months
Secondary	Low density lipoprotein cholesterol	Change from baseline	12 months
Secondary	High density lipoprotein cholesterol	Change from baseline	12 months
Secondary	Fiber	Change from baseline	12 months
Secondary	Satiety evaluation	Visual Analog Scale to evaluate motivation-satiety when eating	[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.
Secondary	24 hours Dietary Recall	24 hours Food habits of overweight and obesity people	12 months
Secondary	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.	Months 6, 7, 8 y 9. Gustatory and olfactory sensory perception of the subjects for the study products.
Secondary	International Physical Activity Questionnaire	People physical activity habits	12 months