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Completed

NCT Number: NCT03554525

Weight Regain After Consumption of Food Supplement and Interventional Diet Program

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

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Change, Body Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fat-binder damm

Dietary Supplement

3 sticks every day during 12 months

Placebo

Dietary Supplement

3 sticks every day during 12 months

Primary outcomes

  1. Weight Regain

    Time frame: 12 months

    Change from baseline in kilograms

Secondary outcomes

  1. Body Mass Index (weight/height^2)

    Time frame: 12 months

    Change from baseline in kg/m^2

  2. Fat mass percentage

    Time frame: 12 months

    Change from baseline in percentage

  3. Body water percentage

    Time frame: 12 months

    Change from baseline in percentage

  4. Lean mass percentage

    Time frame: 12 months

    Change from baseline in percentage

  5. Triglycerides

    Time frame: 12 months

    Change from baseline

  6. Low density lipoprotein cholesterol

    Time frame: 12 months

    Change from baseline

  7. High density lipoprotein cholesterol

    Time frame: 12 months

    Change from baseline

  8. Fiber

    Time frame: 12 months

    Change from baseline

  9. 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.

    Visual Analog Scale to evaluate motivation-satiety when eating

  10. 24 hours Dietary Recall

    Time frame: 12 months

    24 hours Food habits of overweight and obesity people

  11. Sensory perception

    Time frame: 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.

  12. International Physical Activity Questionnaire

    Time frame: 12 months

    People physical activity habits

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study 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

Acronym: fat-binder

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2018
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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