| Eligibility |
Inclusion Criteria:
1. Age = 21 and = 65 years.
2. Participant has type 2 diabetes as evidenced by use of oral antihyperglycemic
medication(s), except for DPP-4 inhibitors, with constant dose for at least two months
prior to screening and baseline visit. Participant is able to maintain medication
number, type and dose throughout the duration of study.
3. Participant with a BMI > 18.5 and = 35.0 kg/m2.
4. Participant is weight stable (has maintained current body weight within 3 kg) for the
two months prior to the screening visit.
5. Male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to
screening visit. A urine pregnancy test is required for all female subjects unless she
is not of childbearing potential, defined as postmenopausal for at least one year
prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy). If female is of childbearing potential, is practicing
one of the following methods of birth control (and will continue through the duration
of the study):
- Condoms, sponge, diaphragm or intrauterine device;
- Oral or parenteral contraceptives for 3 months prior to screening visit;
- Vasectomized partner;
- Total abstinence from sexual intercourse.
6. If the participant is on a chronic medication such as an anti-hypertensive,
lipid-lowering, thyroid medication or hormone therapy, the dosage was constant for at
least two months prior to screening and baseline visit. Participant is able to
maintain medication number, type and dose throughout the duration of study.
7. Participant is willing to follow protocol as described, including consumption of study
product per protocol and completing any forms needed throughout the study.
8. Participant has at least a two-week washout period between completion of a previous
research study that required ingestion of any study food or drug and their start in
the current study.
9. Participant is willing to refrain from taking non-study diabetes-specific formulas
over the entire course of the study.
10. Participant has voluntarily signed and dated an Informed Consent Form (ICF), approved
by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any
participation in the study.
Exclusion Criteria:
1. Participant has a screening HbA1c level <7% or = 10%.
2. Participant uses exogenous insulin or GLP-1 agonists or DPP-4 inhibitors for glucose
control.
3. Participant has confirmed type 1 diabetes and/or had history of diabetic ketoacidosis.
4. Participant has current infection (requiring medication), inpatient surgery or
received systemic corticosteroid treatment (with the exception of inhaled (includes
nasal), topical, and ophthalmic steroids) in the last 3 months; or received
antibiotics in the last 3 weeks.
5. Participant has active malignancy (excluding the following dermal malignancies: basal
cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
6. Participant has significant cardiovascular event within 6 months prior to study entry
or history of congestive heart failure.
7. Participant has end stage organ failure (such as end stage renal disease) or was post
organ transplant.
8. Participant has a history of renal disease or severe gastroparesis.
9. Participant has current hepatic disease.
10. Participant has had bariatric surgery including gastric balloon; history of
gastrointestinal disease (e.g., Crohn's, colitis, celiac) or intestinal surgery that
can interfere with consumption or digestion or absorption of study product.
11. Participant has a chronic, contagious, infectious disease, such as active
tuberculosis, Hepatitis A, B or C, or HIV.
12. Participant has eating disorder, severe dementia or delirium, history of significant
neurological or psychiatric disorder, alcoholism, substance abuse or other conditions
that may interfere with study product consumption or compliance with study protocol
procedures in the opinion of the principal investigator or study physician.
13. Participant is taking any herbals, dietary supplements, or medications, other than
allowed anti-hyperglycemic medications, during the past four weeks prior to screening
visit that could profoundly affect (in the opinion of the principal investigator)
blood glucose or appetite (examples include orlistat, contrive, qsymia, belviq,
incretins, cannabis).
14. Participant uses diabetes-specific formula(s), (e.g. Glucerna, Nestle Nutren Diabetes,
Kalbe Diabetasol, Appeton Nutrition Wellness 60+ Diabetic, ForSure, Penta Sure DM,
Resurge DM, Diben, Diasip, etc.) defined as more than one eating occasion per week in
the last three months.
15. Participant has clotting or bleeding disorders. The use of Plavix® or a similar
anticoagulant drug with no reported difficulty during blood draws is allowed and
participant is able to maintain medication number, type and dose throughout the
duration of study.
16. Participant participates in another study that has not been approved as a concomitant
study by AN.
17. Participant has an allergy or intolerance to any ingredient in the study product, as
reported by the participant.
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