Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes

The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.

Inclusion criteria

• Be male or female, at least 18 years of age
• If age ≥45 years, must have a body mass index ≥ 25 kg/m2
• If age <45 years, must have a body mass index ≥ 25 kg/m2 AND present with at least one additional risk factors for developing diabetes.
• Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (women only)
• Be able to understand the nature and purpose of the study including potential risks and side effects
• Be willing to consent to study participation and to comply with study requirements
• Have a finger stick fasting blood glucose between 105 and 140 mg/dL and a serum fasting glucose between 100 and 125 mg/dL, measured at screening

Exclusion criteria

• Have diabetes (type I or II) or an HBA1c measurement >6.5% at any time in the past or at the screening visit
• Have been taking within 2 weeks of screening any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose metabolism
• Have been taking within 4 weeks of screening any prescription or over-the-counter (OTC) medication that significantly affects glucose metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, Inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors), systemic corticosteroids
• Daily use of non-steroidal anti-inflammatory drugs (NSAIDS) (daily baby aspirin use and continuous use of NSAIDS for 3 days or less for acute aches and pains are acceptable)
• Any co-morbidity or treatment that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
• Anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction
• Eating disorder
• Polycystic ovary syndrome
• Known allergies or intolerance to any substance in the study product
• Are pregnant or breastfeeding women
• History of alcohol, drug, or medication abuse
• Have participated in another study with any investigational product within 1 month of screening
• Had a recent (<3 months) gastrointestinal surgery or any planned surgery during the clinical study