Actively Recruiting
Evaluation of Orange Peel Fermentation for Reducing Body Fat in Adults with Overweight or Fatty Liver Disease
Led by TCI Co., Ltd. · Updated on 2025-01-09
124
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether orange peel fermentation can help reduce body fat in adults who are overweight or have fatty liver disease. This double-blind, randomized study involves adults aged 20 to 65 years with specific body fat or BMI criteria. The study aims to assess changes in body fat and various blood markers over time to understand the effects of the intervention. Participants are randomly assigned to consume either a sachet of orange peel fermentation or a placebo once daily for two months. The study carefully monitors body fat, triglycerides, cholesterol levels, glycemia, liver enzymes, kidney function markers, uric acid, and white blood cell counts at the beginning, 4 weeks, and 8 weeks into the trial. During the study, doctors evaluate participants for overweight or fatty liver conditions and administer questionnaires at each visit. Researchers measure multiple health indicators, including body mass index, visceral fat, and blood markers, to track changes. The trial ensures safety through regular assessments and requires participants to cooperate with contraception if applicable. The total participation period is two months of daily supplement intake with follow-up evaluations.
CONDITIONS
Official Title
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between the ages of 20 and 65 who are willing to sign the consent form
- BMI of 24 or higher or diagnosed with fatty liver
- Male body fat 25% or higher, female body fat 30% or higher
- Not pregnant and willing to use contraception during the trial
- No history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver or kidney disease, cancer, endocrine disease, mental illness, alcohol or drug abuse, or other major organic diseases
You will not qualify if you...
- Pregnant women
- History of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver or kidney disease, cancer, endocrine disease, mental illness, alcohol or drug abuse, or other major organic diseases
- History of major surgery or bariatric surgery
- Use of drugs affecting body fat, waist circumference, or weight (such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, mood stabilizers) currently or within 3 months before screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 114
Actively Recruiting
Research Team
H
HUANG YU-JYUN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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