The Impact of Fruit Juice, Fruit Juice With Pomace, or Whole Fruit on Glycemic Response

Exclusion Criteria

• •1. Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥110 mg/dL at Visit 1. No retest allowed.
• •2. Subject has the presence of a gastrointestinal disease or condition that could potentially interfere with absorption of the study product (including but not limited to inflammatory bowel diseases, ulcers), including history of gastrointestinal surgery (e.g., for weight reduction).
• •3. Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), or biliary disorders, in the opinion of the Clinical Investigator.
• •4. Subject has a history of bariatric surgery.
• •5. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Clinical Investigator.
• •6. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at Visit 1. One retest will be allowed.
• •7. Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• •8. Subject has experienced any major trauma or any other surgical event within three months
• •9. Subject has a known allergy, intolerances, or sensitivity to any of the ingredients in the study products.
• •10. Subject has had a weight loss or gain \>4.5 kg in the 3 months prior to Visit 1.
• •11. Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Investigator) and any treatment (e.g., antibiotic therapy) has been completed at least 5 d prior to testing.
• •12. Subject has a recent history of (within 12 months of Visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse define as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
• •13. Subject has used medications known to influence carbohydrate metabolism, including, but not limited to, protease inhibitors, antipsychotics, adrenergic receptor blockers, diuretics, anti-diabetic agents, and systemic corticosteroids, within 30 d of Visit 1.
• •14. Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 30 d prior to Visit 1.
• •15. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
• •16. Subject has been exposed to any non-registered drug product within 30 days prior to Visit 1.
• •17. Subject has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.