Dihydroberberine Effects on Body Composition and Metabolic Health in Healthy Adults

Part of paid clinical trials in Addison, Illinois.

Sponsor
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Study ID
NCT07322679
Status
Not Yet Recruiting

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Conditions

  • Health Adult Subjects

Eligibility Criteria

Sex
ALL
Age
35 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo （Microcrystalline Cellulose） — DIETARY_SUPPLEMENT
    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.
  • Dihydroberberine（DHB） — DIETARY_SUPPLEMENT
    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.

Study Details

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

Key Dates

Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
Aug 16, 2026
Completion
Sep 25, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo
  • Experimental: Dihydroberberine（DHB）

Primary Outcome Measure

Body weight [ Time Frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Biofortis, Merieux NutriSciencesAddisonIllinois60101
Elizabeth Antoo, MD
[email protected]
630-617-200

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Biofortis, Merieux NutriSciences· Addison, IL

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