NCT07322679

Dihydroberberine Effects on Body Composition and Metabolic Health in Healthy Adults

Effects of Dihydroberberine Supplementation on Body Composition, Glycemic Control, Energy Levels, Appetite, and Mood in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Nanjing Nutrabuilding Bio-tech Co., Ltd. · Academic / Other
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate whether dihydroberberine (DHB) supplementation can improve body composition, blood sugar control, energy levels, appetite, and mood in healthy adults with overweight or mild obesity. The study focuses on men and women aged 35-55 years with a BMI between 27.0 and 33.0 kg/m². The main questions it aims to answer are: Does daily DHB supplementation lead to greater reductions in body weight over 12 weeks compared to placebo? Does DHB improve glycemic responses, appetite regulation, energy levels, and mood, both acutely (short-term) and chronically (over 12 weeks)? Researchers will compare two groups-one receiving DHB (400 mg/day) and the other receiving a placebo-administered as two capsules twice daily for 12 weeks. Participants will: Attend three in-clinic visits over approximately 14 weeks (including screening, baseline, and week 12 visits) Undergo mixed-meal tolerance tests (MTTs) to assess glucose metabolism, appetite, and energy levels Complete body composition assessments (including DXA scans), blood tests (e.g., glucose, insulin, HbA1c), and mood questionnaires (POMS-2) Be monitored for safety throughout the study

Conditions

• Health Adult Subjects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo （Microcrystalline Cellulose）	Participants will take 4 placebo capsules daily for 12 consecutive weeks, with 2 capsules taken in the morning and 2 in the evening. Each capsule contains 200 mg of microcrystalline cellulose, an inert substance used as an inactive control.
DIETARY_SUPPLEMENT	Dihydroberberine（DHB）	Participants will take 4 capsules daily (each containing 100 mg dihydroberberine \[DHB\] and 100 mg microcrystalline cellulose) orally for 12 consecutive weeks, with 2 capsules taken in the morning and 2 in the evening. The total daily dose of DHB is 400 mg.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-08-16
• Completion: 2026-09-25
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States