Recruiting NCT04496895
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, orange peel fermentation.
- Who it may be relevant to
- Registry conditions: Overweight, Fatty Liver Disease. Basic parameters: 20 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To assess whether orange peel fermentation has the effect of reducing body fat in adults
Detailed description
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of overweight or fatty liver is evaluated by the doctor. The questionnaires are collected at every visit of the trial.
Interventions
- Dietary supplement Placebo
consume 1 sachet per day for 2 months - Dietary supplement orange peel fermentation
consume 1 sachet per day for 2 months
Primary outcome measures
- The change of body fat mass [Time frame: Weeks 0, 4 and 8]
- The change of Triglyceride [Time frame: Weeks 0, 4 and 8]
- The change of Total cholestrol [Time frame: Weeks 0, 4 and 8]
- The change of HDL-cholestrol [Time frame: Weeks 0, 4 and 8]
- The change of LDL-cholestrol [Time frame: Weeks 0, 4 and 8]
- The change of body mass index (BMI) [Time frame: Weeks 0, 4 and 8]
- The change of body fat percentage [Time frame: Weeks 0, 4 and 8]
- The change of visceral fat [Time frame: Weeks 0, 4 and 8]
- The change of fasting glycemia [Time frame: Weeks 0, 4 and 8]
- The change of aspartate aminotransferase [Time frame: Weeks 0, 4 and 8]
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, male body fat ≥ 25%, female body fat ≥ 30%.
- Those who are not pregnant and are willing to cooperate with contraception during the trial period.
- 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
- 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).
- No person who has received major surgery or bariatric surgery (according to medical history).
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT04496895 · 201912030RSA