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

Study Overview
=================
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.

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

Conditions
-----------------
Fat-lowering

Intervention / Treatment
-----------------
* Drug: orange peel fermentation
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject. For those with BMI ≥ 24 or fatty liver, men's body fat ≥ 25%, women's body fat ≥ 30% Those who are not pregnant and are willing to cooperate with contraception during the trial period. 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: 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). Those who had undergone major surgery or bariatric surgery (according to medical history). 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orange peel fermentation<br> | Drug: orange peel fermentation<br>* To evaluate whether the fermented orange peel enzyme has the effect of reducing body fat.<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* Placebo without orange peel fermentation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether the fermented orange peel enzyme has the effect of reducing fat. | Obesity related markers | 8 weeks |