| Eligibility |
Inclusion Criteria:
1. =18 to =45 years of age at visit 1.
2. BMI =18.5 and <30.0 kg/m2 at visit 1.
3. Fasting capillary glucose <110 mg/dL at visit 1.
4. Willing to avoid consuming high-polyphenol containing foods (Appendix 2) for 48 h
prior to each test visit.
5. Willing to abstain from alcohol consumption for 24 hours prior to each study visit.
6. Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing
tobacco) within 12 months of visit 1, with no plans to begin use during the study
period.
7. Willing to maintain habitual physical activity level throughout the duration of the
study.
8. Willing to maintain habitual dietary pattern throughout the duration of the study,
including stable intake of current vitamins, minerals, supplements and medications not
interfering with study outcomes.
9. Score of 7 to 10 on the Vein Access Scale at visit 1 (Appendix 3).
10. No health conditions that would prevent him/her from fulfilling the study requirements
as judged by the Clinical Investigator on the basis of medical history.
11. Understands the study procedures and signs forms providing informed consent to
participate in the study and authorizes the release of relevant protected health
information to the Clinical Investigator.
Exclusion Criteria:
1. History or presence of clinically important cardiac, renal, hepatic, endocrine,
pulmonary, biliary, pancreatic, or neurological disorders that may affect the
participant's ability to adhere to the study protocol and/or affect study outcomes, in
the judgment of the Investigator.
2. Uncontrolled hypertension (systolic blood pressure =140 mm Hg or diastolic blood
pressure =90 mm Hg) as defined by the blood pressure measured at visit 1 (section
6.3.1).
3. Unstable use (initiation or change in dose) within 30 days of visit 1 of
antihypertensive medications.
4. Unstable use (initiation or change in dose) within 30 days of visit 1 of thyroid
hormone replacement medications.
5. Use of medications or supplements that may influence carbohydrate metabolism within 30
days of visit 1.
6. Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan,
vegetarian) at the discretion of the Clinical Investigator.
7. Weight loss or gain >4.5 kg in the 2 months prior to visit 1.
8. Currently, or planning to be, on a weight loss regimen during the study.
9. Use of weight loss medication within 90 d of visit 1.
10. History of gastrointestinal surgery for weight reducing purposes.
11. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge
eating) diagnosed by a health professional.
12. Known allergy or sensitivity to any ingredients or potential allergens contained in
the study product.
13. History or presence of cancer in the prior 2 years, except for non-melanoma skin
cancer.
14. History of any major trauma or major surgical event within 2 months of visit 1.
15. Blood donation >450 mL within 8 weeks of visit 2 or plans to donate blood or plasma
during the study period.
16. Female who is pregnant, planning to be pregnant during the study period, lactating, or
is of childbearing potential with unstable use (initiation or change in dose) within
30 days of visit 1) of sex hormones for contraception.
17. Recent history of (within 12 months of screening; visit 1) or strong potential for
alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink =
12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
18. Exposed to any non-registered drug product within 30 days prior to visit 1.
19. Any condition the Investigator believes would interfere with the participant's ability
to provide informed consent or comply with the study protocol, which might confound
the interpretation of the study results or put the person at undue risk.
|
