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
Nanjing Nutrabuilding Bio-tech Co., Ltd.
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
Eligibility
- Age range
- 35–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 35 - 55 years of age (inclusive) at visit 1. * BMI ≥ 27.0 - ≤ 33.0 kg/m2. * Participant has a score of 7 - 10 on the Vein Access Scale Assessment at visit 1. * Non-user or former user (daily use; cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period. * Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD/THC products, and willing to abstain from use throughout the study period (topical creams/lotion…
Interventions
- Dietary SupplementPlacebo （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 SupplementDihydroberberine（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.
Location
- Biofortis, Merieux NutriSciencesAddison, Illinois