Effects of TA-65, a Telomerase Activator on Metabolic Syndrome

Short telomeres are strongly linked to increased risk of cardiovascular disease and diabetes,
indications where tissue aging and senescence play significant roles. Shorter leukocyte
telomere length has been linked to impaired glucose tolerance, Type 2 Diabetes, and coronary
heart disease. Telomere length and telomerase activity have been shown to be significantly
lower in CAD patients. Telomere length may play an important role in predicting
cardiovascular disease and diabetes. TA-65 may not only ameliorate the symptoms associated
with these disease states, but be a preventive measure as well.

In this study, the researchers will investigate whether telomerase activator (TA)-65 can also
improve the metabolic dysregulations associated with metabolic syndrome including oxidative
stress, inflammation, high blood pressure and dyslipidemias.

Inclusion Criteria:

1. Age 32 to 70 years

2. Men and women

3. Proficiency in English

4. Postmenopausal women, or women of childbearing age (premenopausal) must be using some
form of contraception or have had a hysterectomy

5. Classification of metabolic syndrome according to the Adult treatment panel (ATP) III
criteria, meaning that individuals have 3 or more of the following characteristics:

- Waist circumference >102 cm for men or > 88 cm for women

- Triglycerides > 150 mg/d L

- HDL cholesterol < 40 mg/dL for men or < 50 mg/dL for women

- Blood pressure > 130/85 mm Hg or systolic ≥ 130 or diastolic ≥ 85*

- Fasting blood glucose > 100 mg/dL *Or taking blood pressure medications

Exclusion Criteria:

1. Participants who do not fulfill the classification of metabolic syndrome, which means
that they do not have 3 or more of the 5 characteristics previously mentioned

2. Participants with a body mass index (BMI) > 40 kg/m2

3. Current or past diagnosis of liver disease, renal disease, diabetes, cancer, stroke,
heart disease, severe infectious disease, or autoimmune diseases (including but not
limited to multiple sclerosis, lupus, and rheumatoid arthritis)

4. Women who are pregnant, lactating, or planning to become pregnant

5. Use of any glucose-lowering prescriptions or supplements, such as Sulfonylureas
(Glucotrol, Amaryl, chlorpropamide, gliclazide, glimepiride, glipizide, glyburide),
Thiazolidinediones (Avandia, ACTOS, rosiglitazone, pioglitazone), Meglitinides
(Prandin, Starlix), Biguanides (Metformin), Alpha-glucosidase inhibitors (Precose,
Glyset, acarbose, miglitol), Dipeptidyl peptidase (DPP)-4 inhibitors (Januvia,
Onglyza, alogliptin, linagliptin, saxagliptin, sitagliptin), Glucagon-like peptide
(GLP-1) antagonists (exenatide, liraglutide), Meglitinides (nateglinide, repaglinide),
sodium glucose cotransporter (SGLT)-2 inhibitors (canagliflozin) or high dose chromium
or cinnamon supplements

6. Use of immunosuppressants, including azathioprine, cyclophosphamide, basiliximab,
cyclosporine, everolimus, daclizumab, infliximab, mercaptopurine, methotrexate,
muromonab-cluster of differentiation3 (CD3), mycophenolate, pimecrolimus, rituximab,
tacrolimus, sirolimus, prednisone, methylprednisone, dexamethasone, hydrocortisone
(not topical), or prednisolone

7. Use of anticoagulants, including factor Xa inhibitors (rivaroxaban, apixaban),
thrombin inhibitor (dabigatran), vitamin K antagonist (warfarin), heparin,
low-molecular weight heparin, fondaparinux, or antiplatelets (aspirin, cilostazol,
clopidogrel, dipyridamole, prasugrel, ticagrelor, ticlopidine)

8. Use of other categories of drugs, including methadone, Suboxone, monoamine oxidase
(MAO) inhibitors, or lithium.

9. Use of any combination drug product containing any of the individual drugs listed
above

10. Participants who have been consistently taking vitamin, mineral, or multivitamin
supplements prior to recruitment may be admitted into the study if they plan to
maintain their current supplement program. However, subjects may not participate if
they begin taking a new supplement during the 27-week study period.

11. Fasting plasma triglycerides ≥ 500 mg/dL, glucose ≥ 126 mg/dL, or blood pressure >
145/100 mm Hg or systolic > 145 mm Hg or diastolic > 100 mm Hg