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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05750342
Other study ID # UCAMCFE-00032
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date May 6, 2024

Study information

Verified date January 2023
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 6, 2024
Est. primary completion date March 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Experimental Product Caqui
Supplement extracted from persimmon
Control product placebo
Product with identical characteristics to the experimental product.

Locations

Country Name City State
Spain Catholic University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total fat mass Dual X-ray absorptiometry (DEXA), measured in grams. From baseline to 84 days
Primary Fat mass in torso Dual X-ray absorptiometry (DEXA), measured in grams. From baseline to 84 days
Primary Fat mass in lower limbs Dual X-ray absorptiometry (DEXA), measured in grams. From baseline to 84 days
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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
Secondary 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.
Secondary 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.
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