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

NCT07210684 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-10-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo 400 mg

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.

DIETARY_SUPPLEMENT

Dihydroberberine（DHB）400 mg

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.

Sponsors & Collaborators

  • Biofortis, Merieux NutriSciences

    collaborator INDUSTRY

  • Nanjing Nutrabuilding Bio-tech Co., Ltd.

    lead OTHER

Principal Investigators

  • Elizabeth Antoo, MD · Biofortis, Inc. Merieux NutriSciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2026-01-15
Completion
2026-03-15

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07210684 on ClinicalTrials.gov