Randomized Clinical Trial to Evaluate the Efficacy of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- Universidad Católica San Antonio de Murcia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Evaluation of weight loss
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of this randomized, parallel, two-arm, placebo-controlled, double-blind, multicenter clinical trial is to evaluate the efficacy of a dietary supplement on weight loss and psychological well-being in overweight individuals.
Detailed Description
The duration of the study will be 6 months during which the investigational product or placebo will be consumed according to the assignment. Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
Investigators
Desirée Victoria Montesinos
Principal Investigator
Universidad Católica San Antonio de Murcia
Eligibility Criteria
Inclusion Criteria
- •Adults (age: 30 - 70 YO)
- •BMI over 25 kg/m
- •Subjects who are smokers or non-smokers, but in any case who do not modify their nicotinic habits during their participation in the study.
Exclusion Criteria
- •Subjects with eating disorders.
- •BMI less than 25 Kg/m
- •History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- •Participation in another clinical trial in the three months prior to the study.
- •Unwillingness or inability to comply with clinical trial procedures.
- •Pregnant woman.
- •Participants with an active daily exercise activity.
- •Subjects whose condition makes them ineligible for the study at the investigator's discretion.
Outcomes
Primary Outcomes
Evaluation of weight loss
Time Frame: From baseline to 6 months later
Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.
Secondary Outcomes
- Dietary intake(From baseline to 6 months later)
- Quality of life by WHOQOL-BREF(From baseline to 6 months later)
- Quality of life by SF-36(From baseline to 6 months later)
- Depression(From baseline to 6 months later)
- Anxiety(From baseline to 6 months later)
- Stress(From baseline to 6 months later)