Dihydroberberine for Healthy Adults

(DHB Trial)

EA
Overseen ByElizabeth Antoo, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Nanjing Nutrabuilding Bio-tech Co., Ltd.

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 35-55 with a BMI of 27.0 to 33.0, who don't use tobacco or marijuana regularly and are willing to follow study procedures and use a smartphone app. They must have good vein access for blood draws.

Inclusion Criteria

I agree to follow the study rules and sign consent forms.
My BMI is between 27.0 and 33.0.
My vein access score is between 7 and 10.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive DHB or placebo for 12 weeks, with assessments including MTTs, body composition, and mood questionnaires

12 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Dihydroberberine

Trial Overview

The trial tests if dihydroberberine (DHB) can improve body composition, blood sugar control, energy levels, appetite, and mood in overweight individuals compared to a placebo over 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Dihydroberberine(DHB)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nanjing Nutrabuilding Bio-tech Co., Ltd.

Lead Sponsor

Biofortis, Merieux NutriSciences

Industry Sponsor

Trials
9
Recruited
850+