SupplementationPERSOBNCT05750342
Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity.
A study testing Experimental Product Caqui in people with Supplementation and Obesity, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Supplementation, Obesity
- What is being tested?
- Experimental Product Caqui
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Supplementation, Obesity
- Being tested
- Experimental Product Caqui, Control product placebo
- Keywords
- Obesity, Overweight, Persimmon
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Product CaquiDietary supplement
Supplement extracted from persimmon
Control product placeboDietary supplement
Product with identical characteristics to the experimental product.
| Study group | Role | What they receive |
|---|---|---|
| Caqui | Experimental | Subjects will consume two capsules daily. Each capsule will be taken before the two main meals. Receives: Dietary Supplement: Experimental Product Caqui |
| Placebo | Placebo comparator | The product will have the same characteristics as the experimental product. They will consume two capsules per day, one before the two main meals. Receives: Dietary Supplement: Control product placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fat mass
Dual X-ray absorptiometry (DEXA), measured in grams.
Measured: From baseline to 84 days
Fat mass in torso
Dual X-ray absorptiometry (DEXA), measured in grams.
Measured: From baseline to 84 days
Fat mass in lower limbs
Dual X-ray absorptiometry (DEXA), measured in grams.
Measured: From baseline to 84 days
Secondary outcomes (14)
Fat mass
body composition measured by bioimpedancemetry
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Lipidic Metabolism
Total cholesterol, LDL, oxidized LDL, HDL, and triglycerides. Will be measured in milligrams per deciliter.
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.
Glycidic profile
Blood glucose, glycated hemoglobin and basal insulin. It was measured in milligrams per deciliter.
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.
Quality of life in people with obesity
Assessed using the Obesity and Quality of Life Consulting test (IWQol-Lite)
Measured: 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
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.
Inflammatory profile - PCR
C-Reactive Protein will be measured
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.
Inflammatory profile - IL-6
Interlucin 6 will be measured
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.
Gut microbiota
Evaluated with stool sample
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Feb 2023
- Primary completion28 Mar 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750342
- Sponsor's protocol ID
- UCAMCFE-00032
- Acronym
- PERSOB
- Status last verified
- Jan 2023
- First submitted
- 30 Jan 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perez-Pinero S, Munoz-Carrillo JC, Echepare-Taberna J, Herrera-Fernandez C, Munoz-Camara M, Avila-Gandia V, Lopez-Roman FJ. Efficacy of a Dietary Supplement Extracted from Persimmon (Diospyros kaki L.f.) in Overweight Healthy Adults: A Randomized, Double-Blind, Controlled Clinical Trial. Foods. 2024 Dec 17;13(24):4072. doi: 10.3390/foods13244072.
PubMed 39767014
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05750342
- Acronym / sponsor ID
- PERSOB / UCAMCFE-00032
- Conditions
- Supplementation, Obesity
- Keywords
- Obesity, Overweight, Persimmon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caqui | Experimental | Dietary Supplement: Experimental Product CaquiSubjects will consume two capsules daily. Each capsule will be taken before the two main meals. |
| Placebo | Placebo comparator | Dietary Supplement: Control product placeboThe product will have the same characteristics as the experimental product. They will consume two capsules per day, one before the two main meals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Product CaquiSupplement extracted from persimmon | Dietary supplement | Caqui |
| Control product placeboProduct with identical characteristics to the experimental product. | Dietary supplement | Placebo |
Primary outcome
Total fat mass
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in torso
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
Fat mass in lower limbs
Time frame: From baseline to 84 days
Dual X-ray absorptiometry (DEXA), measured in grams.
14 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 39767014Perez-Pinero S, Munoz-Carrillo JC, Echepare-Taberna J, Herrera-Fernandez C, Munoz-Camara M, Avila-Gandia V, Lopez-Roman FJ. Efficacy of a Dietary Supplement Extracted from Persimmon (Diospyros kaki L.f.) in Overweight Healthy Adults: A Randomized, Double-Blind, Controlled Clinical Trial. Foods. 2024 Dec 17;13(24):4072. doi: 10.3390/foods13244072.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Product Caqui in people with Supplementation and Obesity, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fat mass (time frame: From baseline to 84 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.