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CompletedNCT05647915BRAVOUpdated Jan 29, 2025

Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and NAFLD

A Phase 4 interventional study of Berberine plus lifestyle intervention and Placebo plus lifestyle intervention in Obesity, Obesity, Abdominal and NAFLD, sponsored by China National Center for Cardiovascular Diseases. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by China National Center for Cardiovascular Diseases · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
337
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine in reducing visceral and liver adipose tissue among individuals with obesity and non-alcoholic fatty liver disease (NAFLD) in China.

Read the detailed description

The trial aims to evaluate the efficacy and safety of berberine treatment for obesity and NAFLD. Potential eligible patients will be recruited from 10-20 medical centers in China. After a 4-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 1.0 g per day plus lifestyle intervention (Arm A) or placebo plus lifestyle intervention (Arm B). The participants will be asked to attend the visit at least once every 2 months, and be followed up for 6 months.

02

Conditions studied

  • Obesity
  • Obesity, Abdominal
  • NAFLD

Keywords

  • berberine hydrochloride
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 337 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants aged ≥18 years
  • Participants with obesity (i.e., BMI ≥ 28 kg/m2) and abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)
  • Participants with NAFLD diagnosed by ultrasound, computed tomography or magnetic resonance imaging

Exclusion criteria

Exclusion Criteria:

  • Patients with established coronary heart disease, stroke, or peripheral arterial disease
  • Patients diagnosed with diabetes or taking oral glucose-lowering drugs
  • Patients with severely uncontrolled hypertension (i.e., SBP≥180mmHg and/or DBP ≥110mmHg)
  • Excess alcohol consumption (i.e., alcohol ≥ 20 g/day in female or alcohol ≥ 30 g/day in male)
  • Other causes of fatty liver disease, including alcohol or drug abuse, hepatitis B or C, autoimmune, hepatolenticular degeneration, total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, β -lipoprotein deficiency, lipid atrophy diabetes, Mauriac syndrome, etc.
  • Patients with thyroid disease, including hyperthyroidism or hypothyroidism
  • Patients with cardiac insufficiency
  • ALT or AST ≥ 3 times upper limit of normal, liver cirrhosis or hepatic insufficiency
  • Patients with renal insufficiency: estimated glomerular filtration rate (eGFR) \< 60 ml/(min×1.73m2)
  • Patients who had weight loss surgery, or are currently taking drugs for weight loss, or plan to have weight loss surgery or drugs in the following 6 months
  • Patients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Taking berberine or drug containing berberine in the past 1 month
  • Any adverse reaction to berberine
  • Severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)
  • Patients who had to use long-term or intermittent corticosteroids, immunosuppressants, antibiotics, or other drugs that affect inflammatory biomarkers
  • Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial
  • Patients with malignant tumors
  • Patients with mental disorders, cognitive disorders, and/or other serious diseases
  • Those who participated or have been participating other trials during the last 3 months
  • Any other conditions that may hinder the compliance to the study intervention or follow-up visit
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
337 participants (actual)

Study arms

  • Experimental
    berberine group

    Berberine hydrochloride plus lifestyle intervention

    Drug: Berberine plus lifestyle intervention

  • Placebo comparator
    placebo group

    Placebo plus lifestyle intervention

    Behavioral: Placebo plus lifestyle intervention

Interventions

  • DrugBerberine plus lifestyle intervention

    berberine hydrochloride 500mg twice a day for 6 months plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.

  • BehavioralPlacebo plus lifestyle intervention

    Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.

06

What researchers measure

Primary outcomes

  1. Change of visceral fat content

    Measurement of visceral fat by computed tomography

    Time frame: 6 months

  2. Change of liver fat content

    Measurement of liver fat content by computed tomography

    Time frame: 6 months

Secondary outcomes

  1. Change of fasting plasma glucose

    Measurement of fasting plasma glucose (FPG)

    Time frame: 6 months

  2. Change of HbA1c

    Measurement of HbA1c

    Time frame: 6 months

  3. Change of 2-hour postprandial blood glucose

    Measurement of 2-hour postprandial blood glucose (2hPG)

    Time frame: 6 months

  4. Change of homeostatic model assessment-insulin resistance

    Homeostatic model assessment-insulin resistance (HOMA-IR)= (fasting insulin (mIU/L) \* FPG (mmol/L)) / 22.5

    Time frame: 6 months

  5. Change of homeostasis model assessment-β cell

    Homeostatic model assessment (HOMA-β) = (20 x fasting insulin (mIU/L)) / (FPG (mmol/L) - 3.5)

    Time frame: 6 months

  6. Change of homeostasis model assessment-insulin sensitivity

    Homeostatic model assessment-insulin sensitivity (HOMA-IS)= 1/ HOMA-IR

    Time frame: 6 months

  7. Change of serum triglyceride

    Measurement of serum triglyceride (TG)

    Time frame: 6 months

  8. Change of high-density lipoprotein cholesterol

    Measurement of high-density lipoprotein cholesterol

    Time frame: 6 months

  9. Change of low-density lipoprotein cholesterol

    Measurement of low-density lipoprotein cholesterol

    Time frame: 6 months

  10. Change of total cholesterol

    Measurement of total cholesterol

    Time frame: 6 months

  11. Change of lipoprotein (a)

    Measurement of lipoprotein (a)

    Time frame: 6 months

  12. Change of apolipoprotein

    Measurement of apolipoprotein

    Time frame: 6 months

  13. Normalization of glucose parameters among participants with prediabetes

    Meeting all three criteria: 1) FPG\<6.1 mmol/L; 2) 2hPG\<7.8 mmol/L; 3) HbA1c\<5.7%

    Time frame: 6 months

  14. Change of metabolic syndrome z-score

    Metabolic syndrome z-score calculated by the five components, including waist circumference, HDL-C, blood pressure, TG and FPG. Higher score indicates greater severity of metabolic syndrome

    Time frame: 6 months

  15. Change of visceral fat index

    Visceral fat index calculated by waist circumference, body mass index, TG, HDL-C. Higher index indicates higher content of visceral fat

    Time frame: 6 months

  16. Change of fat liver index

    Fat liver index (FLI) calculated by TG, body mass index, gamma-glutamyltransferase (γ-GGT), waist circumference. Higher index indicates higher content of liver fat

    Time frame: 6 months

  17. Change of triglyceride glucose index

    Triglyceride glucose index (TyG) calculated by TG and FPG. Higher index indicates higher insulin resistance

    Time frame: 6 months

  18. Change of serum urine acid

    Measurement of serum urine acid

    Time frame: 6 months

  19. Change of serum homocysteine

    Measurement of serum homocysteine

    Time frame: 6 months

  20. Change of body weight

    Measurement of body weight in kg

    Time frame: 6 months

  21. Change of body mass index

    Weight and height will be combined to report BMI in kg/m\^2

    Time frame: 6 months

  22. Change of waist circumference

    Measurement of waist circumference in cm

    Time frame: 6 months

  23. Change of waist-hip ratio

    Waist circumference and hip circumference will be combined to report waist-hip ratio.

    Time frame: 6 months

  24. Change of waist-height ratio

    Waist circumference and height will be combined to report waist-height ratio.

    Time frame: 6 months

  25. Change of systolic blood pressure

    Measurement of systolic blood pressure (SBP)

    Time frame: 6 months

  26. Change of diastolic blood pressure

    Measurement of diastolic blood pressure (DBP)

    Time frame: 6 months

Other outcomes

  1. Change of alanine aminotransferase

    Measurement of alanine aminotransferase (ALT)

    Time frame: 6 months

  2. Change of aspartate aminotransferase

    Measurement of aspartate aminotransferase (AST)

    Time frame: 6 months

  3. Change of γ-GGT

    Measurement of γ-GGT

    Time frame: 6 months

  4. Change of fibrosis-4 score

    Fibrosis-4 score (FIB-4) calculated by age, ALT, AST, platelet count. Higher score indicates higher extent of liver fibrosis.

    Time frame: 6 months

  5. Change of NAFLD fibrosis score

    NAFLD fibrosis score (NFS) calculated by age, BMI, status of dysglycemia, ALT, AST, platelet count, serum albumin concentration. Higher score indicates higher extent of liver fibrosis.

    Time frame: 6 months

  6. Change of hypersensitive C-reactive protein

    Measurement of hypersensitive C-reactive protein

    Time frame: 6 months

  7. Change of interleukin-6

    Measurement of interleukin-6 (IL-6)

    Time frame: 6 months

  8. Change of tumor necrosis factor-α

    Measurement of tumor necrosis factor-α (TNF-α)

    Time frame: 6 months

  9. Change of transforming growth factor-β

    Measurement of transforming growth factor-β (TGF-β)

    Time frame: 6 months

  10. Change of leptin

    Measurement of leptin

    Time frame: 6 months

  11. Change of adiponectin

    Measurement of adiponectin

    Time frame: 6 months

  12. Change of short chain fatty acids

    Measurement of short chain fatty acids

    Time frame: 6 months

  13. Change of trimethylamine

    Measurement of trimethylamine (TMA)

    Time frame: 6 months

  14. Change of trimethylamine oxide

    Measurement of trimethylamine oxide (TMAO)

    Time frame: 6 months

  15. Improvement of left ventricular diastolic function (LVDF) among participants with abnormal LVDF at baseline

    Measurement of LVDF by echocardiogram

    Time frame: 6 months

  16. Change of pericardial fat among participants with abnormal LVDF

    Measurement of pericardial fat by computed tomography

    Time frame: 6 months

07

Study locations

1 site
  • Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
    Beijing, China
08

References and documents

Publications

  • Yan HM, Xia MF, Wang Y, Chang XX, Yao XZ, Rao SX, Zeng MS, Tu YF, Feng R, Jia WP, Liu J, Deng W, Jiang JD, Gao X. Efficacy of Berberine in Patients with Non-Alcoholic Fatty Liver Disease. PLoS One. 2015 Aug 7;10(8):e0134172. doi: 10.1371/journal.pone.0134172. eCollection 2015. PubMed 26252777 ↗
  • Harrison SA, Gunn N, Neff GW, Kohli A, Liu L, Flyer A, Goldkind L, Di Bisceglie AM. A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes. Nat Commun. 2021 Sep 17;12(1):5503. doi: 10.1038/s41467-021-25701-5. PubMed 34535644 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05647915
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Sponsor
First posted
Dec 13, 2022
Start date
Jul 6, 2023
Primary completion
Aug 9, 2024
Completion
Aug 9, 2024
Last update
Jan 29, 2025

Study contacts

Jing Li, PhD
principal investigator · National Center for Cardiovascular Diseases
Haibo Zhang, MD
principal investigator · National Center for Cardiovascular Diseases

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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