Catholic University of Murcia
Murcia, 30107, Spain
NCT Number: NCT05750342
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Murcia, 30107, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supplement extracted from persimmon
Product with identical characteristics to the experimental product.
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
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.
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.
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.
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.
The waist and hips will be measured, in centimeters.
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.
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.
Blood glucose, glycated hemoglobin and basal insulin. It was measured in milligrams per deciliter.
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.
Assessed using the Obesity and Quality of Life Consulting test (IWQol-Lite)
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.
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.
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.
Interlucin 6 will be measured
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.
Evaluated with stool sample
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
Measured with Actigraph wGT3X-BT
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.
"24-hour recall" food survey.
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.
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)
Universidad Católica San Antonio de Murcia
Other
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.
Acronym: PERSOB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07504068
Adults With Overweight and Obesity, Aging
Valencia, Spain
View Trial DetailsNCT07404930
Behavior, Breast Feeding
Bologna, BO, Italy
View Trial DetailsNCT07304921
Lipid Metabolism, Omega-3 Polyunsaturated Fatty Acids
Riga, Latvia
View Trial DetailsNCT05444959
Aerobic Capacity, Fat Free Mass
Prague, Prague 6, Czechia
View Trial Details