Dihydroberberine Effects on Body Composition and Metabolic Health in Healthy Adults

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

NCT Number	NCT07322679
Lead Sponsor	Nanjing Nutrabuilding Bio-tech Co., Ltd. Collaborators: Biofortis, Merieux NutriSciences
Conditions	Health Adult Subjects
Enrollment	120 participants
Start Date	2025-12-15
Primary Completion	2026-08-16 (estimated)
Study Completion	2026-09-25 (estimated)
Updated on ClinicalTrials.gov	2026-01-07