Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity. (PERSOB)

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Supplementation; Obesity

Treatments: Dietary Supplement: Control product placebo; Dietary Supplement: Experimental Product Caqui

Study type: Interventional

Funder types: Other

Identifiers

NCT05750342

UCAMCFE-00032

Details and patient eligibility

About

Randomized, controlled, double-blind clinical trial, with two parallel branches depending on the product consumed (experimental product and placebo product) and single-center, to measure the efficacy of a supplement extracted from Persimmon on overweight and obesity grade I in subjects with BMI over 25.

Full description

The product to be consumed is a supplement extracted from the Persimmon. Participants will consume the product for 84 days. They will take one capsule before the two main meals.

Subjects will have to make 3 visits to the laboratory. In the initial visit it will be verified if the subject meets the criteria required by the study. Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned).

In the other two visits, the subjects will carry out the appropriate tests for taking of data colletion. These visits will be separated by 84 days of product consumption.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects of both sexes aged 18-65 years.
• Subjects with a body mass index greater than 25 and less than 35.
• Volunteers able to understand the clinical study and willing to comply with the study procedures and the procedures and requirements of the study.

Exclusion criteria

• Subjects undergoing treatment that may affect body weight.
• Subjects with acute diseases.
• Volunteers with a history or presence of chronic pulmonary disorders, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular, or malignant tumor pathology or disease.
• Subjects who have undergone major surgery in the last 3 months.
• Subjects who quit smoking in the last 6 months or who intend to quit during the study.
• Subjects with allergies or eating disorders.
• Volunteers who are participating in another study that involves blood draws or dietary intervention.
• Pregnant or breastfeeding women.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Caqui

Experimental group

Description:

Subjects will consume two capsules daily. Each capsule will be taken before the two main meals.

Treatment:

Dietary Supplement: Experimental Product Caqui

Placebo

Placebo Comparator group

Description:

The product will have the same characteristics as the experimental product. They will consume two capsules per day, one before the two main meals.

Treatment:

Dietary Supplement: Control product placebo