Skip to main content
OpenTrials
Completed

NCT Number: NCT05758363

Effect of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM San Antonio Catholic University of Murcia

Murcia, 30107, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults (age: 30 - 70 YO)
  • BMI over 25 kg/m2.
  • 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/m2.
  • 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.

Treatment and study plan

Consumption of dietary supplement.

Dietary Supplement

Consumption of a dietary supplement rich in glutathione, selenium, zinc, vitamin D and EPA/DHA. 1 capsule per day of the dietary supplement with breakfast.

Consumption of control product

Other

Consumption of 1 capsule per day of control product of identical appearance with breakfast.

Primary outcomes

  1. 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

  1. Quality of life by WHOQOL-BREF

    Time frame: From baseline to 6 months later

    World Health Organization Quality of Life Brief version test. The raw scores are transformed into a normalized scale ranging from 4 to 20 and from 0 to 100. Higher scores indicating better quality of life.

  2. Quality of life by SF-36

    Time frame: From baseline to 6 months later

    Short Form 36 Health Survey Questionnaire (SF-36). The SF-36 contains 36 items that measure eight dimensions or scales. The scores for each dimension will be calculated in both raw and transformed form as indicated in the manual, with higher scores indicating better health status for that particular dimension.

  3. Depression

    Time frame: From baseline to 6 months later

    Beck Depression Inventory test. The score ranges from 0 to 63, where the higher the score, the greater the signs of depression.

  4. Stress

    Time frame: From baseline to 6 months later

    Perceived Stress Scale (PSS). Total scores range from 0 to 56 (higher scores indicate higher levels of stress).

  5. Anxiety

    Time frame: From baseline to 6 months later

    State-Trait Anxiety Inventory (STAI) Test. Scores can vary between 0 to a maximum of 60. Higher scores correlate positively with higher levels of anxiety.

  6. Dietary intake

    Time frame: From baseline to 6 months later

    Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Randomized Clinical Trial to Evaluate the Efficacy of a Dietary Supplement on Weight Loss and Psychological Wellbeing in Overweight Individuals

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2023
Registry last updated
Mar 20, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.