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ObesityPhase 4BRAVONCT05647915

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

A Phase 4 study testing Berberine plus lifestyle intervention in people with Obesity and Obesity, Abdominal, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Obesity, Abdominal, NAFLD
What is being tested?
Berberine plus lifestyle intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
337 participants
Where
1 siteChina
Study dates
6 Jul 2023to 9 Aug 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases

    Beijing

Other trials in China

About this study

Official title: Assess the Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and Non-alcoholic Fatty Liver Disease

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.

Being tested
Berberine plus lifestyle intervention, Placebo plus lifestyle intervention
Keywords
berberine hydrochloride
Medical subject headings
Obesity, Obesity, Abdominal, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Berberine plus lifestyle interventionDrug

    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.

  • Placebo plus lifestyle interventionBehavioural

    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.

Study groups in NCT05647915
Study groupRoleWhat they receive
berberine groupExperimentalBerberine hydrochloride plus lifestyle intervention
Receives: Drug: Berberine plus lifestyle intervention
placebo groupPlacebo comparatorPlacebo plus lifestyle intervention
Receives: Behavioral: Placebo plus lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of visceral fat content

    Measurement of visceral fat by computed tomography

    Measured: 6 months

  2. Change of liver fat content

    Measurement of liver fat content by computed tomography

    Measured: 6 months

Secondary outcomes (26)

  1. Change of fasting plasma glucose

    Measurement of fasting plasma glucose (FPG)

    Measured: 6 months

  2. Change of HbA1c

    Measurement of HbA1c

    Measured: 6 months

  3. Change of 2-hour postprandial blood glucose

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

    Measured: 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

    Measured: 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)

    Measured: 6 months

  6. Change of homeostasis model assessment-insulin sensitivity

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

    Measured: 6 months

  7. Change of serum triglyceride

    Measurement of serum triglyceride (TG)

    Measured: 6 months

  8. Change of high-density lipoprotein cholesterol

    Measurement of high-density lipoprotein cholesterol

    Measured: 6 months

  9. Change of low-density lipoprotein cholesterol

    Measurement of low-density lipoprotein cholesterol

    Measured: 6 months

  10. Change of total cholesterol

    Measurement of total cholesterol

    Measured: 6 months

  11. Change of lipoprotein (a)

    Measurement of lipoprotein (a)

    Measured: 6 months

  12. Change of apolipoprotein

    Measurement of apolipoprotein

    Measured: 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%

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 6 months

  17. Change of triglyceride glucose index

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

    Measured: 6 months

  18. Change of serum urine acid

    Measurement of serum urine acid

    Measured: 6 months

  19. Change of serum homocysteine

    Measurement of serum homocysteine

    Measured: 6 months

  20. Change of body weight

    Measurement of body weight in kg

    Measured: 6 months

  21. Change of body mass index

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

    Measured: 6 months

  22. Change of waist circumference

    Measurement of waist circumference in cm

    Measured: 6 months

  23. Change of waist-hip ratio

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

    Measured: 6 months

  24. Change of waist-height ratio

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

    Measured: 6 months

  25. Change of systolic blood pressure

    Measurement of systolic blood pressure (SBP)

    Measured: 6 months

  26. Change of diastolic blood pressure

    Measurement of diastolic blood pressure (DBP)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2022
  2. Study start6 Jul 2023
  3. Primary completion9 Aug 2024
  4. Study completion9 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05647915
Sponsor's protocol ID
2021-CXGC04-2
Acronym
BRAVO
Status last verified
Jan 2025
First submitted
16 Nov 2022
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Lei L, Wang B, Zhao L, Li J, Yan X, Jiang J, Wang L, Ren G, Li Y, Cheng X, Yan X, Zhu Y, Guo Y, Zhong H, Zhang H, Li J; BRAVO Collaborative Group. Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2554152. doi: 10.1001/jamanetworkopen.2025.54152.

    PubMed 41543854

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Berberine plus lifestyle intervention in people with Obesity and Obesity, Abdominal, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of visceral fat content (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05647915, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.

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