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

Phase 4

• Conditions: Fat-lowering
• Interventions: Drug: orange peel fermentation; Drug: Placebo

• Registration Number: NCT04910646
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-06-02
• Last Update Posted: 2021-06-02
• Study Start: 2021-06-15
• Primary Completion: 2024-06-14
• Study Completion: 2024-06-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
orange peel fermentation	orange peel fermentation	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To evaluate whether the fermented orange peel enzyme has the effect of reducing fat.	8 weeks	Obesity related markers