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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Overweight

Treatments: Other: Consumption of control product; Dietary Supplement: Consumption of dietary supplement.

Study type: Interventional

Funder types: Other

Identifiers

NCT05758363

CE012309

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

Consumption of dietary supplement capsules for 6 months.

Treatment:

Dietary Supplement: Consumption of dietary supplement.

Control Group

Placebo Comparator group

Description:

Identically appearing placebo capsules consumed for 6 months.

Treatment:

Other: Consumption of control product