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

NCT05758363 | Completed

• 1 other identifier: CE012309
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• Evaluation of weight loss

  Evaluation of weight loss by assessment of anthropometric measurements - Waist/hip ratio - Waist/height ratio.

  From baseline to 6 months later

Secondary Outcomes (6)

• 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

• Stress

  From baseline to 6 months later

• Anxiety

  From baseline to 6 months later

Study Arms (2)

Experimental Group

EXPERIMENTAL

Consumption of dietary supplement capsules for 6 months.

Dietary Supplement: Consumption of dietary supplement.

Control Group

PLACEBO COMPARATOR

Identically appearing placebo capsules consumed for 6 months.

Other: Consumption of control product

Interventions

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.

Experimental Group

Consumption of control product OTHER

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

Control Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

UCAM San Antonio Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Overweight

Interventions

Dietary Supplements; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 7, 2023
• Study Start: March 9, 2023
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

ES (1)