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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Supplementation, Obesity

Intervention / Treatment
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* Dietary Supplement: Experimental Product Caqui
* Dietary Supplement: Control product placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caqui<br>Subjects will consume two capsules daily. Each capsule will be taken before the two main meals. | Dietary Supplement: Experimental Product Caqui<br>* Supplement extracted from persimmon<br>|
| Placebo Comparator: Placebo<br>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<br>* Product with identical characteristics to the experimental product.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Persimmon