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

NCT04910646 | Unknown Phase 4

• 1 other identifier: 201912030RSA
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  Obesity related markers

  8 weeks

Study Arms (2)

orange peel fermentation

EXPERIMENTAL

Drug: orange peel fermentation

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

orange peel fermentation DRUG

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

orange peel fermentation

Placebo DRUG

Placebo without orange peel fermentation

placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Central Study Contacts

Jyh-Ming Liou, MD

CONTACT

23123456; jyhmingliou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: June 15, 2021
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: June 2, 2021

Record last verified: 2021-05