Blood Sugar Take Care and Glucose Metabolism

SUBJECT INCLUSION CRITERIA: STEP 1

1. Age ≥ 18 years

2. Subject meets American Diabetes Association criteria for diabetes testing in
asymptomatic, undiagnosed individuals:

1. If age ≥45 years, subject must have a body mass index ≥ 25 kg/m2 for United
States and ≥ 24 kg/m2 for Indonesia

2. If age <45 years, subject must have a body mass index ≥ 25 kg/m2 for United
States and ≥ 24 kg/m2 for Indonesia AND present with at least one of the
following risk factors:

- Have a first-degree relative with diabetes

- Habitually physically inactive

- Race is African-American, Hispanic American, Native American, Asian
American, or Pacific Islander

- Have delivered a baby weighing >9 lb or have been diagnosed with
gestational diabetes mellitus

- Hypertensive (≥140/90)

- Known HDL cholesterol level 35 mg/dl

- Known triglyceride level ≥250 mg/dl

- On previous testing, had impaired glucose tolerance or impaired fasting
glucose

- History of vascular disease

3. Stable body weight (<5% change) in the last 3 months

4. Agree to use contraception throughout study period, unless postmenopausal or
surgically sterile (females only)

5. Able to understand the nature and purpose of the study including potential risks and
side effects

6. Willing to consent to study participation and to comply with study requirements

SUBJECT EXCLUSION CRITERIA

1. Known diabetes (type I or II)

2. Recent use (within 2 weeks of screening) of any dietary supplement including vitamin
and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal
ingredient/product that significantly affects glucose or lipid metabolism

3. Recent use (within 4 weeks of screening) of any prescription or OTC medication that
significantly affects glucose or lipid metabolism, including but not limited to,
sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase
inhibitors, DPP-4 inhibitors, systemic corticosteroids, statins, fibrates, niacin,
and bile acid sequestrants

4. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDS); (daily baby aspirin use
acceptable)

5. Any comorbidity 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

6. Anticipated changes in dietary patterns or physical activity levels during the study,
including attempts at body weight reduction

7. Eating disorder

8. Polycystic ovary syndrome

9. Known allergies to any substance in the study product

10. Pregnant or breastfeeding women

11. History of alcohol, drug, or medication abuse

12. Participation in another study with any investigational product within 3 months of
screening

13. Recent (<3 months) gastrointestinal surgery or any planned surgery during the
treatment period

SUBJECT INCLUSION CRITERIA: STEP 2

1. Fasting glucose between 95 and 130 mg/dl, based on portable glucometer reading

SUBJECT INCLUSION CRITERIA: STEP 3

1. Impaired fasting glucose, based on the American Diabetes Association definition of
fasting serum glucose between 100 and 125 mg/dl

2. Impaired glucose tolerance, based on the American Diabetes Association definition of
serum glucose between 140 and 199 mg/dl 2 hours after a 75 g glucose load