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