Obesity Clinical Trial
— PERSOBOfficial 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.
Verified date | January 2023 |
Source | Universidad Católica San Antonio de Murcia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Catholic University of Murcia | Murcia |
Lead Sponsor | Collaborator |
---|---|
Universidad Católica San Antonio de Murcia |
Spain,
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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