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Completed

NCT Number: NCT05750342

Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental Product Caqui

Dietary Supplement

Supplement extracted from persimmon

Control product placebo

Dietary Supplement

Product with identical characteristics to the experimental product.

Primary outcomes

  1. Total fat mass

    Time frame: From baseline to 84 days

    Dual X-ray absorptiometry (DEXA), measured in grams.

  2. Fat mass in torso

    Time frame: From baseline to 84 days

    Dual X-ray absorptiometry (DEXA), measured in grams.

  3. Fat mass in lower limbs

    Time frame: From baseline to 84 days

    Dual X-ray absorptiometry (DEXA), measured in grams.

Secondary outcomes

  1. Fat mass

    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

  2. Muscle mass

    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

  3. Percentage of fat mass

    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

  4. Waist-hip perimeter

    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.

  5. Lipidic Metabolism

    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.

  6. Glycidic profile

    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.

  7. Quality of life in people with obesity

    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)

  8. Total antioxidant capacity of plasma

    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

  9. Inflammatory profile - PCR

    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

  10. Inflammatory profile - IL-6

    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

  11. Gut microbiota

    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

  12. Physical activity

    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

  13. Nutritional assessment

    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.

  14. Liver safety variables

    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)

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study 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.

Acronym: PERSOB

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2023
Registry last updated
May 17, 2024

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.

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