Evaluating the effects of orange peel fermentation on reducing body fat in adults

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

This study is testing if eating fermented orange peel can help adults with overweight or fatty liver disease lose body fat.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: TCI Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT04496895 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy of orange peel fermentation in lowering body fat among adults diagnosed with overweight or fatty liver disease. It employs a double-blind, randomized design where participants will consume either the fermented orange peel or a placebo daily for two months. Clinical evaluations and questionnaires will be conducted at each visit to monitor progress and gather data on the intervention's effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 20 to 65 with a BMI of 24 or higher or those diagnosed with fatty liver disease.

Not a fit: Patients with a history of significant medical conditions such as cardiovascular disease, organ transplantation, or major organic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a natural dietary intervention for reducing body fat and improving liver health in adults.

How similar studies have performed: While the specific approach of using orange peel fermentation is novel, similar dietary interventions have shown promise in other studies for weight management and liver health.

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, male body fat ≥ 25%, female body fat ≥ 30%.
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or 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. No person who has received major surgery or bariatric surgery (according to medical history).
3. I have used drugs that affect body fat, waist circumference or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability in the current or 3 months before participating in the screening Drugs (according to medical history).

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: LIOU JYH-MING, Doctor — National Taiwan University Hospital
• Study coordinator: Huang Yu-Jyun

Conditions Overweight; Fatty Liver Disease