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

Obesity Clinical Trial

— PERSOB  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750342
• Other study ID #: UCAMCFE-00032
• Status: Recruiting
• Phase: N/A
• 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
• 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: Recruiting
• 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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Supplementation

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.