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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fat-lowering
• Intervention / Treatment: Drug: orange peel fermentation; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2021
• Primary Completion (Anticipated): June 14, 2024
• Study Completion (Anticipated): June 14, 2024

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 201912030RSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No