Clinical trial NCT05750342: Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity.
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
Overall status: COMPLETED
Phase: NA
Conditions: Supplementation
Obesity
Keywords: Obesity
Overweight
Persimmon
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Total fat mass
timeFrame: From baseline to 84 days
measure: Fat mass in torso
timeFrame: From baseline to 84 days
measure: Fat mass in lower limbs
timeFrame: From baseline to 84 days
Secondary outcomes:
measure: Fat mass
timeFrame: 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.
measure: Muscle mass
timeFrame: 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.
measure: Percentage of fat mass
timeFrame: 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.
measure: Waist-hip perimeter
timeFrame: 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.
measure: Lipidic Metabolism
timeFrame: 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.
measure: Glycidic profile
timeFrame: 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.
measure: Quality of life in people with obesity
timeFrame: 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.
measure: Total antioxidant capacity of plasma
timeFrame: 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.
measure: Inflammatory profile - PCR
timeFrame: 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.
measure: Inflammatory profile - IL-6
timeFrame: 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.
measure: Gut microbiota
timeFrame: 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.
measure: Physical activity
timeFrame: 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
measure: Nutritional assessment
timeFrame: 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.
measure: Liver safety variables
timeFrame: 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.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: