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

TCI

Status: Enrolling

Conditions: Overweight; Fatty Liver Disease

Treatments: Dietary Supplement: orange peel fermentation; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04496895

201912030RSA

Details and patient eligibility

About

To assess whether orange peel fermentation has the effect of reducing body fat in adults

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

consume 1 sachet per day for 2 months

Treatment:

Dietary Supplement: Placebo

orange peel fermentation

Experimental group

Description:

consume 1 sachet per day for 2 months

Treatment:

Dietary Supplement: orange peel fermentation