Back to resultsClinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity. (PERSOB)
Primary Purpose
Supplementation, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental Product Caqui
Control product placebo
Sponsored by
About this trial
This is an interventional other trial for Supplementation focused on measuring Obesity, Overweight, Persimmon
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.
Sites / Locations
- Catholic University of MurciaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Caqui
Placebo
Arm Description
Subjects will consume two capsules daily. Each capsule will be taken before the two main meals.
The product will have the same characteristics as the experimental product. They will consume two capsules per day, one before the two main meals.
Outcomes
Primary Outcome Measures
Total fat mass
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in torso
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in lower limbs
Dual X-ray absorptiometry (DEXA), measured in grams.
Secondary Outcome Measures
Fat mass
body composition measured by bioimpedancemetry
Muscle mass
body composition measured by bioimpedancemetry
Percentage of fat mass
body composition measured by bioimpedancemetry
Waist-hip perimeter
The waist and hips will be measured, in centimeters.
Lipidic Metabolism
Total cholesterol, LDL, oxidized LDL, HDL, and triglycerides. Will be measured in milligrams per deciliter.
Glycidic profile
Blood glucose, glycated hemoglobin and basal insulin. It was measured in milligrams per deciliter.
Quality of life in people with obesity
Assessed using the Obesity and Quality of Life Consulting test (IWQol-Lite)
Total antioxidant capacity of plasma
It will be done through the OxiSelect Total Antioxidant Capacity (TAC) Assay Kit
Inflammatory profile - PCR
C-Reactive Protein will be measured
Inflammatory profile - IL-6
Interlucin 6 will be measured
Gut microbiota
Evaluated with stool sample
Physical activity
Measured with Actigraph wGT3X-BT
Nutritional assessment
"24-hour recall" food survey.
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)
Full Information
NCT ID
NCT05750342
First Posted
January 30, 2023
Last Updated
February 19, 2023
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT05750342
Brief Title
Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
July 28, 2023 (Anticipated)
Study Completion Date
September 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supplementation, Obesity
Keywords
Obesity, Overweight, Persimmon
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caqui
Arm Type
Experimental
Arm Description
Subjects will consume two capsules daily. Each capsule will be taken before the two main meals.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The product will have the same characteristics as the experimental product. They will consume two capsules per day, one before the two main meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental Product Caqui
Intervention Description
Supplement extracted from persimmon
Intervention Type
Dietary Supplement
Intervention Name(s)
Control product placebo
Intervention Description
Product with identical characteristics to the experimental product.
Primary Outcome Measure Information:
Title
Total fat mass
Description
Dual X-ray absorptiometry (DEXA), measured in grams.
Time Frame
From baseline to 84 days
Title
Fat mass in torso
Description
Dual X-ray absorptiometry (DEXA), measured in grams.
Time Frame
From baseline to 84 days
Title
Fat mass in lower limbs
Description
Dual X-ray absorptiometry (DEXA), measured in grams.
Time Frame
From baseline to 84 days
Secondary Outcome Measure Information:
Title
Fat mass
Description
body composition measured by bioimpedancemetry
Time Frame
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.
Title
Muscle mass
Description
body composition measured by bioimpedancemetry
Time Frame
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.
Title
Percentage of fat mass
Description
body composition measured by bioimpedancemetry
Time Frame
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.
Title
Waist-hip perimeter
Description
The waist and hips will be measured, in centimeters.
Time Frame
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.
Title
Lipidic Metabolism
Description
Total cholesterol, LDL, oxidized LDL, HDL, and triglycerides. Will be measured in milligrams per deciliter.
Time Frame
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.
Title
Glycidic profile
Description
Blood glucose, glycated hemoglobin and basal insulin. It was measured in milligrams per deciliter.
Time Frame
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.
Title
Quality of life in people with obesity
Description
Assessed using the Obesity and Quality of Life Consulting test (IWQol-Lite)
Time Frame
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.
Title
Total antioxidant capacity of plasma
Description
It will be done through the OxiSelect Total Antioxidant Capacity (TAC) Assay Kit
Time Frame
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.
Title
Inflammatory profile - PCR
Description
C-Reactive Protein will be measured
Time Frame
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.
Title
Inflammatory profile - IL-6
Description
Interlucin 6 will be measured
Time Frame
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.
Title
Gut microbiota
Description
Evaluated with stool sample
Time Frame
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.
Title
Physical activity
Description
Measured with Actigraph wGT3X-BT
Time Frame
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
Title
Nutritional assessment
Description
"24-hour recall" food survey.
Time Frame
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.
Title
Liver safety variables
Description
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)
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fco Javier López Román
Phone
968278523
Ext
523
Email
jlroman@ucam.edu
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity.
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