Effects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes

Part of paid clinical trials in Addison, Illinois.

Sponsor
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Study ID
NCT07210684
Status
Recruiting
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Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo 400 mg — DIETARY_SUPPLEMENT
    Participants will receive 4 placebo capsules daily for 6 weeks. Each capsule contains 100 mg of microcrystalline cellulose, which serves as a inactive control substance.
  • Dihydroberberine（DHB）400 mg — DIETARY_SUPPLEMENT
    Participants will receive 4 capsules of DHB (Dihydroberberine) 100 mg each, orally, once daily for 6 weeks. The total daily dose is 400 mg of DHB.

Study Details

The goal of this clinical trial is to learn if Dihydroberberine (DHB) supplementation affects adults with pre-diabetes. The main questions it aims to answer are: Does DHB supplementation increase the concentration of GLP-1 in the blood? Does DHB supplementation affect appetite, mood, and energy levels? Does DHB supplementation affect body weight, blood sugar control and insulin? Researchers will compare DHB supplementation to a placebo (a look-alike substance that contains no drug) to see if DHB has any effect. Participants will: Take DHB or a placebo every day for 6 weeks. Participate in tests to measure GLP-1 levels, blood glucose, insulin and other markers. Have their continuous blood sugar profiles (with CGMs) monitored to see how much time their blood sugar spends in a healthy range. Rate their appetite, mood, and energy levels using a visual analog scale.

Key Dates

Start date
Aug 6, 2025
Status verified
Sep 2025
Primary completion
Jan 15, 2026
Completion
Mar 15, 2026

Study Design

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

Arms

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

Primary Outcome Measure

Change in Postprandial Total GLP-1 Cmax After Single Dose of DHB [ Time Frame: Visit 3, Day 0 (after single dose administration) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Merieux NutriSciencesAddisonIllinois60101
Elizabeth Antoo, MD
[email protected]
(630) 617-2000

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Merieux NutriSciences· Addison, IL

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