The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults

NCT ID: NCT04496895

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-12
• Study Completion Date: 2025-12-31

Brief Summary

To assess whether orange peel fermentation has the effect of reducing body fat in adults

Detailed Description

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of overweight or fatty liver is evaluated by the doctor. The questionnaires are collected at every visit of the trial.

Conditions

Overweight; Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

consume 1 sachet per day for 2 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

orange peel fermentation

consume 1 sachet per day for 2 months

Group Type: EXPERIMENTAL

orange peel fermentation

Intervention Type: DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

Interventions

Placebo

consume 1 sachet per day for 2 months

Intervention Type: DIETARY_SUPPLEMENT

orange peel fermentation

consume 1 sachet per day for 2 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.

2. For those with BMI ≥ 24 or fatty liver, male body fat ≥ 25%, female body fat ≥ 30%.

3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.

4. No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).

Exclusion Criteria

1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).

2. No person who has received major surgery or bariatric surgery (according to medical history).

3. I have used drugs that affect body fat, waist circumference or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability in the current or 3 months before participating in the screening Drugs (according to medical history).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TCI Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LIOU JYH-MING, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

HUANG YU-JYUN

Role: CONTACT

nneder34@gmail.com

0934173838

Facility Contacts

chi fu chiang, Ph.D

Role: primary

Other Identifiers

201912030RSA

Identifier Type: -

Identifier Source: org_study_id