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

NCT ID: NCT05750342

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-05-06

Brief Summary

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.

Detailed 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.

Conditions

Supplementation; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Caqui

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

Group Type: EXPERIMENTAL

Experimental Product Caqui

Intervention Type: DIETARY_SUPPLEMENT

Supplement extracted from persimmon

Placebo

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

Group Type: PLACEBO_COMPARATOR

Control product placebo

Intervention Type: DIETARY_SUPPLEMENT

Product with identical characteristics to the experimental product.

Interventions

Experimental Product Caqui

Supplement extracted from persimmon

Intervention Type: DIETARY_SUPPLEMENT

Control product placebo

Product with identical characteristics to the experimental product.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

References

Perez-Pinero S, Munoz-Carrillo JC, Echepare-Taberna J, Herrera-Fernandez C, Munoz-Camara M, Avila-Gandia V, Lopez-Roman FJ. Efficacy of a Dietary Supplement Extracted from Persimmon (Diospyros kaki L.f.) in Overweight Healthy Adults: A Randomized, Double-Blind, Controlled Clinical Trial. Foods. 2024 Dec 17;13(24):4072. doi: 10.3390/foods13244072.

Reference Type: DERIVED

PMID: 39767014 (View on PubMed)

Other Identifiers

UCAMCFE-00032

Identifier Type: -

Identifier Source: org_study_id