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

Randomized Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity Grade I in Subjects With Body Mass Index Greater Than 25.

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Supplementation
• Intervention / Treatment: Dietary supplement: Experimental Product Caqui; Dietary supplement: Control product placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caqui; Subjects will consume two capsules daily. Each capsule will be taken before the two main meals.	Dietary supplement: Experimental Product Caqui; Supplement extracted from persimmon
Placebo Comparator: 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.	Dietary supplement: Control product placebo; Product with identical characteristics to the experimental product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fat mass	Dual X-ray absorptiometry (DEXA), measured in grams.	From baseline to 84 days
Fat mass in torso	Dual X-ray absorptiometry (DEXA), measured in grams.	From baseline to 84 days
Fat mass in lower limbs	Dual X-ray absorptiometry (DEXA), measured in grams.	From baseline to 84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat mass	body composition measured by bioimpedancemetry	A record of body composition will be made twotimes during the 84 days of consumption. Measures will be taken at baseline, and at 84 days. For this we will use a TANITA.
Muscle mass	body composition measured by bioimpedancemetry	A record of body composition will be made twotimes during the 84 days of consumption. Measures will be taken at baseline, and at 84 days. For this we will use a TANITA.
Percentage of fat mass	body composition measured by bioimpedancemetry	A record of body composition will be made twotimes during the 84 days of consumption. Measures will be taken at baseline, and at 84 days. For this we will use a TANITA.
Waist-hip perimeter	The waist and hips will be measured, in centimeters.	A record of body composition will be made twotimes during the 84 days of consumption. Measures will be taken at baseline, and at 84 days. For this we will use a TANITA.
Lipidic Metabolism	Total cholesterol, LDL, oxidized LDL, HDL, and triglycerides. Will be measured in milligrams per deciliter.	Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of product intake.
Glycidic profile	Blood glucose, glycated hemoglobin and basal insulin. It was measured in milligrams per deciliter.	Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of product intake.
Quality of life in people with obesity	Assessed using the Obesity and Quality of Life Consulting test (IWQol-Lite)	The questionnaire will be carried out twice. The first time at the beginning and the second after carrying out 84 days of consumption of the product under study.
Total antioxidant capacity of plasma	It will be done through the OxiSelect Total Antioxidant Capacity (TAC) Assay Kit	Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of product intake.
Inflammatory profile - PCR	C-Reactive Protein will be measured	Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of product intake.
Inflammatory profile - IL-6	Interlucin 6 will be measured	Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of product intake.
Gut microbiota	Evaluated with stool sample	Stool collection will be performed twice on subjects. The first time at the beginning and the second after 84 days of consumption of the product under study.
Physical activity	Measured with Actigraph wGT3X-BT	An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study
Nutritional assessment	"24-hour recall" food survey.	The food recall will be performed twice on the subjects. The first time at the beginning and the second after carrying out 84 days of consumption of the product under study. In each one a total of 7 days will be collected.
Liver safety variables	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)	Hematological samples were taken before (day 0) and after consumption of the product (day 84) both in the control group and in the experimental group.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): May 6, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 19, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Persimmon
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: UCAMCFE-00032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No