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

NCT04496895 | Recruiting

• 1 other identifier: 201912030RSA
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight; Fatty Liver Disease

Outcome Measures

Primary Outcomes (15)

• The change of body fat mass

  The body fat mass (kg) was assessed by InBody770

  Weeks 0, 4 and 8

• The change of Triglyceride

  Venous blood was sampled to measure concentrations of Triglyceride

  Weeks 0, 4 and 8

• The change of Total cholestrol

  Venous blood was sampled to measure concentrations of Total cholestrol

  Weeks 0, 4 and 8

• The change of HDL-cholestrol

  Venous blood was sampled to measure concentrations of HDL-cholestrol

  Weeks 0, 4 and 8

• The change of LDL-cholestrol

  Venous blood was sampled to measure concentrations of LDL-cholestrol

  Weeks 0, 4 and 8

• The change of body mass index (BMI)

  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.

  Weeks 0, 4 and 8

• The change of body fat percentage

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

  Weeks 0, 4 and 8

• The change of visceral fat

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

  Weeks 0, 4 and 8

• The change of fasting glycemia

  Venous blood was sampled to measure concentrations of fasting glycemia

  Weeks 0, 4 and 8

• The change of aspartate aminotransferase

  Venous blood was sampled to measure concentrations of aspartate aminotransferase

  Weeks 0, 4 and 8

• The change of alanine aminotransferase

  Venous blood was sampled to measure concentrations of alanine aminotransferase

  Weeks 0, 4 and 8

• The change of albumin

  Venous blood was sampled to measure concentrations of creatine

  Weeks 0, 4 and 8

• The change of creatine

  Venous blood was sampled to measure concentrations of creatine

  Weeks 0, 4 and 8

• The change of uric acid

  Venous blood was sampled to measure concentrations of uric acid

  Weeks 0, 4 and 8

• The change of white blood cell

  Venous blood was sampled to measure concentrations of white blood cell

  Weeks 0, 4 and 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

consume 1 sachet per day for 2 months

Dietary Supplement: Placebo

orange peel fermentation

EXPERIMENTAL

consume 1 sachet per day for 2 months

Dietary Supplement: orange peel fermentation

Interventions

Placebo DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

Placebo

orange peel fermentation DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

orange peel fermentation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 114, Taiwan

RECRUITING

MeSH Terms

Conditions

Overweight; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• LIOU JYH-MING, Doctor

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HUANG YU-JYUN

CONTACT

0934173838; nneder34@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: August 3, 2020
• Study Start: November 12, 2022
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

TW (1)