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

Nanjing Nutrabuilding Bio-tech Co., Ltd.

Status: Enrolling

Conditions: Prediabetes

Treatments: Dietary Supplement: Dihydroberberine（DHB）400 mg; Dietary Supplement: Placebo 400 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07210684

STERLING IRB ID: 14195-EAAntoo

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1.35 - 65 years of age (inclusive). 2.BMI 25.0 - 35.0 kg/m2 (inclusive). 3.HbA1c 5.7% - 6.4% (39 - 47 mmol/mol, inclusive) measured at visit 1. 4.Participant has a score of 7 - 10 on the Vein Access Scale Assessment at visit 1.

5.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.

6.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/lotions are allowed).

7.Willing to wear a CGM sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM.

8.Willing to use personal smart phone with operating system capable of downloading and operating the Cronometer and Dexcom CGM apps for diet records and blood glucose, respectively.

9.Willing to adhere to all study procedures, including lifestyle considerations, and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

Exclusion criteria

1. Extreme Diets: Extreme dietary habits (e.g., ketogenic, vegan/vegetarian) at investigator's discretion.
2. Intense Exercise: Moderate-to-intense physical training (≥5 hours/week).
3. Weight Instability/Program: Recent weight changes (>4.5 kg≤90 d) or current/planned weight change program.
4. Abnormal Labs: Abnormal lab test results of clinical significance at Visit 1 (one re-test allowed).
5. Uncontrolled Chronic Illness: Uncontrolled or clinically important pulmonary, cardiac, hepatic, renal, endocrine (T1D/T2D excluded), hematologic, immunologic, neurologic, psychiatric, or biliary disorders.
6. Clinically Important GI: Clinically important GI condition interfering with study product (e.g., IBD, celiac, weight loss surgery history).
7. Uncontrolled HTN: Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg).
8. Cancer History: History or presence of cancer in the prior 2 years (except non-melanoma skin cancer).
9. Active Infection: Signs/symptoms of active infection ≤5 d of Visit 1.
10. Anti-Hyperglycemics: Recent use (≤6 mo) of any prescription anti-hyperglycemic medication.
11. Other Supplements: Use of dietary supplements (other than approved multivitamin) ≤14 d of Visit 1.
12. Alcohol/Substance Abuse: History (≤12 months) of alcohol (>14 drinks/week) or substance abuse.
13. Antibiotics: Antibiotic use ≤90 d of Visit 1.
14. Regular NSAIDs: Regular use (≥3 days/week≤30 d) of anti-inflammatory medications.
15. Steroid Use: Recent use (≤30 d) of oral/injectable steroids, or high-dose topical/inhaled steroids.
16. Unregistered Drug: Exposure to any non-registered drug product ≤30 d prior to Visit 1
17. Medication Instability: Unstable dose (≤90 d) of any other prescription medications (PRN excluded).
18. Psychiatric Hospitalization: Major affective/psychiatric disorder requiring hospitalization ≤12 months prior to Visit 1.
19. Recent Trauma/Surgery: Major trauma or any surgical event ≤30 d of Visit 1.
20. Recent GI Prep: Endoscopy or colonoscopy preparation ≤90 d prior to Visit 1.
21. Planned Surgery: Scheduled or planning elective surgical procedures during the study.
22. Female Status: Pregnancy, lactation, planning pregnancy, or unwillingness to use approved contraception.
23. Allergies: Known sensitivity or allergy to any study products or foods.
24. Investigator Discretion: Any condition that interferes with compliance, confounds results, or presents undue risk.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo 400 mg

Dihydroberberine（DHB）

Experimental group

Treatment:

Dietary Supplement: Dihydroberberine（DHB）400 mg