NCT05750342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
Last Updated

May 17, 2024

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

January 30, 2023

Last Update Submit

May 17, 2024

Conditions

SupplementationObesity

Keywords

ObesityOverweightPersimmon

Outcome Measures

Primary Outcomes (3)

  • Total fat mass

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

    From baseline to 84 days

  • Fat mass in torso

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

    From baseline to 84 days

  • Fat mass in lower limbs

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

    From baseline to 84 days

Secondary Outcomes (14)

  • Fat mass

    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

    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

    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

    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

    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.

  • +9 more secondary outcomes

Study Arms (2)

Caqui

EXPERIMENTAL

Subjects will consume two capsules daily. Each capsule will be taken before the two main meals.

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.

Dietary Supplement: Control product placebo

Interventions

Experimental Product CaquiDIETARY_SUPPLEMENT

Supplement extracted from persimmon

Caqui
Control product placeboDIETARY_SUPPLEMENT

Product with identical characteristics to the experimental product.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Related Publications (1)

  • 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.

    PMID: 39767014DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2023

First Posted

March 1, 2023

Study Start

February 1, 2023

Primary Completion

March 28, 2024

Study Completion

May 6, 2024

Last Updated

May 17, 2024

Record last verified: 2023-01

Locations

ES(1)