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NCT Number: NCT04496895

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

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

Recruiting

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Key information

Conditions

Overweight Body Weight Digestive System Diseases Fatty Liver Fatty Liver Disease Liver Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan, 114

Location status: Recruiting

Location contact

chi fu chiang, Ph.D

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo

Dietary Supplement

consume 1 sachet per day for 2 months

orange peel fermentation

Dietary Supplement

consume 1 sachet per day for 2 months

Other names: Citrus reticulata enzymes, Meta-up!, Tangerlean

Primary outcomes

  1. The change of body fat mass

    Time frame: Weeks 0, 4 and 8

    The body fat mass (kg) was assessed by InBody770

  2. The change of Triglyceride

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of Triglyceride

  3. The change of Total cholestrol

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of Total cholestrol

  4. The change of HDL-cholestrol

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of HDL-cholestrol

  5. The change of LDL-cholestrol

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of LDL-cholestrol

  6. The change of body mass index (BMI)

    Time frame: Weeks 0, 4 and 8

    BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.

  7. The change of body fat percentage

    Time frame: Weeks 0, 4 and 8

    The body fat percentage (%) was assessed by InBody770.

  8. The change of visceral fat

    Time frame: Weeks 0, 4 and 8

    The visceral fat (10 cm^2) was assessed by InBody770.

  9. The change of fasting glycemia

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of fasting glycemia

  10. The change of aspartate aminotransferase

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of aspartate aminotransferase

  11. The change of alanine aminotransferase

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of alanine aminotransferase

  12. The change of albumin

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of creatine

  13. The change of creatine

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of creatine

  14. The change of uric acid

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of uric acid

  15. The change of white blood cell

    Time frame: Weeks 0, 4 and 8

    Venous blood was sampled to measure concentrations of white blood cell

Study contacts

Contact information is provided by the study sponsor or research team.

HUANG YU-JYUN

CONTACT

[email protected]

0934173838

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2020
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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