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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
80
Supplement extracted from persimmon
Product with identical characteristics to the experimental product.
Catholic University of Murcia
Murcia, Spain
Total fat mass
Dual X-ray absorptiometry (DEXA), measured in grams.
Time frame: From baseline to 84 days
Fat mass in torso
Dual X-ray absorptiometry (DEXA), measured in grams.
Time frame: From baseline to 84 days
Fat mass in lower limbs
Dual X-ray absorptiometry (DEXA), measured in grams.
Time frame: From baseline to 84 days
Fat mass
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.
Muscle mass
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.
Percentage of fat mass
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.
Waist-hip perimeter
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.
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Lipidic Metabolism
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.
Glycidic profile
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.
Quality of life in people with obesity
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.
Total antioxidant capacity of plasma
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.
Inflammatory profile - PCR
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.
Inflammatory profile - IL-6
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.
Gut microbiota
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.
Physical activity
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
Nutritional assessment
"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.
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)
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.