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

NCT ID: NCT04910646

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2024-06-14

Brief Summary

Overweight and obesity can lead to the occurrence of many chronic diseases. In addition to the body mass value (BMI), the excess body fat can also be used as criteria for assessing obesity. Citrus peels are rich in many substances including limonene, Nobiletin, 3-methoxynobiletin, and flavonoids. They could be used for lowering blood pressure and reducing blood pressure, anti-anxiety and sleep aid and etc. Fermentation technology is used to ferment the peel to increase the content of neutral components in citrus peel. Therefore, I want to evaluate whether the fermented orange peel enzyme has the effect of reducing fat.

Conditions

Fat-lowering

Study Design

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

Study Groups

orange peel fermentation

Group Type: EXPERIMENTAL

orange peel fermentation

Intervention Type: DRUG

To evaluate whether the fermented orange peel enzyme has the effect of reducing body fat.

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo without orange peel fermentation

Interventions

orange peel fermentation

To evaluate whether the fermented orange peel enzyme has the effect of reducing body fat.

Intervention Type: DRUG

Placebo

Placebo without orange peel fermentation

Intervention Type: DRUG

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, men's body fat ≥ 25%, women's body fat ≥ 30%

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

4. Those who have no history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental disease, alcohol or drug abuse, and 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. Those who had undergone major surgery or bariatric surgery (according to medical history).

3. Currently or within 3 months before participating in the screening, those subjects used drugs that can affect body fat or increase weight significantly, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability Drugs (according to medical history) will be excluded.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jyh-Ming Liou, MD

Role: CONTACT

jyhmingliou@gmail.com

23123456 ext. 63541

Other Identifiers

201912030RSA

Identifier Type: -

Identifier Source: org_study_id