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Table 1 Inclusion and exclusion criteria for the study

From: Efficacy and safety of HIMABERB® Berberine on glycemic control in patients with prediabetes: double-blind, placebo-controlled, and randomized pilot trial

INCLUSION CRITERIA

1. Age 18 to 55 years

2. Male or female gender

3. Females of childbearing age to agree to use birth control methods during the trial period and show a negative pregnancy test at the time of recruitment

4. Fulfillment of the prediabetic diagnostic criteria as per the American Diabetes Association, taken within 12 weeks. (FPG between 5.6 and 6.9 mmol/L; HbA1c between 5.7% and 6.4%; and 2 h-OGTT between 7.8 and 11.1 mmol/L)

5. Agreement to continue the current diet and refrain from any new supplements

6. Ability to read and understand English

7. Agreement to provide informed consent to the trial with the ability to understand the risks and benefits of the protocol

8. Willingness to complete intake form, supplement and diet diary, and records associated with the study

9. Willingness to cooperate for follow-up calls and visits

EXCLUSION CRITERIA

1. Pregnant or lactating women, or women planning to become pregnant in the next 12 weeks

2. Transgender individuals or individuals taking a hormonal injection

3. Comorbidities including malnourishment, impaired hepatic or renal function, cardiac diseases, any acute/severe diseases, or having undergone bariatric surgery

4. Currently taking weight loss medications, any oral hypoglycemic medication, insulin injection, or steroids

5. Current daily use of herbal/nonherbal supplements

6. Daily tobacco use, or individuals with any substance abuse issues in the past or present

7. Known allergies to any substances in the product

8. Any significant neurological and/or psychiatric conditions