---
title: Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and NAFLD
nct_id: NCT05647915
overall_status: COMPLETED
phase: PHASE4
sponsor: China National Center for Cardiovascular Diseases
study_type: INTERVENTIONAL
primary_condition: Obesity
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05647915.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05647915"
ct_last_update_post_date: 2025-01-29
last_seen_at: "2026-05-12T07:34:39.303Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and NAFLD

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

**NCT ID:** [NCT05647915](https://clinicaltrials.gov/study/NCT05647915)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 337
- **Lead Sponsor:** China National Center for Cardiovascular Diseases
- **Conditions:** Obesity, Obesity, Abdominal, NAFLD
- **Start Date:** 2023-07-06
- **Completion Date:** 2024-08-09
- **CT.gov Last Update:** 2025-01-29

## Brief 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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:

* 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
```

## Arms

- **berberine group** (EXPERIMENTAL) — Berberine hydrochloride plus lifestyle intervention
- **placebo group** (PLACEBO_COMPARATOR) — Placebo plus lifestyle intervention

## Interventions

- **Berberine plus lifestyle intervention** (DRUG) — 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 intervention** (BEHAVIORAL) — 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.

## Primary Outcomes

- **Change of visceral fat content** _(time frame: 6 months)_ — Measurement of visceral fat by computed tomography
- **Change of liver fat content** _(time frame: 6 months)_ — Measurement of liver fat content by computed tomography

## Secondary Outcomes

- **Change of fasting plasma glucose** _(time frame: 6 months)_
- **Change of HbA1c** _(time frame: 6 months)_
- **Change of 2-hour postprandial blood glucose** _(time frame: 6 months)_
- **Change of homeostatic model assessment-insulin resistance** _(time frame: 6 months)_
- **Change of homeostasis model assessment-β cell** _(time frame: 6 months)_
- **Change of homeostasis model assessment-insulin sensitivity** _(time frame: 6 months)_
- **Change of serum triglyceride** _(time frame: 6 months)_
- **Change of high-density lipoprotein cholesterol** _(time frame: 6 months)_
- **Change of low-density lipoprotein cholesterol** _(time frame: 6 months)_
- **Change of total cholesterol** _(time frame: 6 months)_
- **Change of lipoprotein (a)** _(time frame: 6 months)_
- **Change of apolipoprotein** _(time frame: 6 months)_
- **Normalization of glucose parameters among participants with prediabetes** _(time frame: 6 months)_
- **Change of metabolic syndrome z-score** _(time frame: 6 months)_
- **Change of visceral fat index** _(time frame: 6 months)_
- **Change of fat liver index** _(time frame: 6 months)_
- **Change of triglyceride glucose index** _(time frame: 6 months)_
- **Change of serum urine acid** _(time frame: 6 months)_
- **Change of serum homocysteine** _(time frame: 6 months)_
- **Change of body weight** _(time frame: 6 months)_
- **Change of body mass index** _(time frame: 6 months)_
- **Change of waist circumference** _(time frame: 6 months)_
- **Change of waist-hip ratio** _(time frame: 6 months)_
- **Change of waist-height ratio** _(time frame: 6 months)_
- **Change of systolic blood pressure** _(time frame: 6 months)_
- **Change of diastolic blood pressure** _(time frame: 6 months)_

## Locations (1)

- Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases, Beijing, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fuwai hospital, chinese academy of medical sciences, national center for cardiovascular diseases|beijing||china` — added _(2026-05-12)_

---

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