The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTCI Co., Ltd.
About this trial
To assess whether orange peel fermentation has the effect of reducing body fat in adults
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Dietary supplementconsume 1 sachet per day for 2 months
orange peel fermentation
Dietary supplementconsume 1 sachet per day for 2 months
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: orange peel fermentationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The change of body fat mass
The body fat mass (kg) was assessed by InBody770
Time frame
Weeks 0, 4 and 82
The change of Triglyceride
Venous blood was sampled to measure concentrations of Triglyceride
Time frame
Weeks 0, 4 and 83
The change of Total cholestrol
Venous blood was sampled to measure concentrations of Total cholestrol
Time frame
Weeks 0, 4 and 84
The change of HDL-cholestrol
Venous blood was sampled to measure concentrations of HDL-cholestrol
Time frame
Weeks 0, 4 and 8Sponsors and contacts
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Source ClinicalTrials.gov