The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM

Inclusion Criteria:

1. Subject has voluntarily signed and dated an informed consent form, approved by an
Institutional Review Board/Independent Ethics Committee, and provided Health Insurance
Portability and Accountability Act authorization (HIPAA) or other privacy
authorization prior to any participation in study.

2. Subject states that he/she had type 2 diabetes, as evidenced by use of
anti-hyperglycemic medication or managed on lifestyle intervention only with A1C >7%

3. Subject is between 30 and 80 years of age.

4. Subject on stable dose of antihyperglycemic medications for the past 3 months or
lifestyle intervention

5. Subject is a 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).

6. If a female is of childbearing potential, she is practicing one of the following
methods of birth control (and continued 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.

7. Subject's BMI is > 25 kg/m2.

8. Subject has A1C between 7-10%

9. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid
medication or hormone therapy, subject has been on stable dose for at least three
months prior to screening visit. These medications will not be changed during
intervention unless it is mandatory.

Exclusion Criteria:

1. Subjects using exogenous insulin since insulin titration may impact the primary
endpoint.

2. Subject states that he/she had a history of diabetic ketoacidosis.

3. Subject is pregnant or lactating.

4. Subject uses corticosteroid treatment with the exception of inhaled or topical
steroids in the last 3 months; or antibiotics within the last 3 weeks prior to the
screening visit.

5. Subject states that he/she had an active malignancy (excluding the following dermal
malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the
cervix).

6. Subject states that he/she has had a recent cardiovascular event (e.g., myocardial
infarction, stroke) ≤ six months prior to screening visit; or stated history of
congestive heart failure.

7. Subject states that he/she has had end stage organ failure (such as end stage renal
disease) or had status post organ transplant.

8. Subject states that he/she has had a history of renal disease (Creatinine >1.5mg/dL or
GFR <60 mL/min/1.73 m2).

9. Subject states that he/she has had current hepatic disease.

10. Subject has history of gastroparesis.

11. Subject states that he/she has had a chronic, contagious, infectious disease

12. Subject states that he/she has had clotting or bleeding disorders.

13. Subject is known to be allergic or intolerant to any ingredient found in the study
products.

14. Subject is known to have a history of special nutritional need requiring special diet.

15. Subject is currently participating in any weight loss program.

16. Subject has used meal replacements during the 3 months prior to the start of the
study.

17. Subject has history of bariatric surgery.