Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0

To investigate the safety, tolerance and acceptability of a lifestyle modification and
targeted nutraceuticals for balanced bowel function in generally healthy volunteers. To
evaluate safety and tolerability, blood samples were drawn for blood counts, metabolic
profiles, plasma lipids, and additional cardiovascular risk factors. Quality of life
questionnaires, medical symptom questionnaire were evaluated at baseline, week 1, week 2 and
week 4. Vitals signs, weight and body composition were monitored at each visit.

Inclusion Criteria:

- Men and women ≥ 18 and ≤ 69 years old

- Generally healthy and meeting entrance criteria

- Score ≥ 8 points on the Purify Readiness Scale (Appendix B)

- Willingness to make required lifestyle changes during study participation

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Change in prescription medications, over-the-counter medications, medical foods, and
nutritional supplements within 30 days prior to Day 1 and for the duration of the
study.

- Use of medications classified as narcotics 15 days prior to Day 1 and for the duration
of the study.

- Use of prescription medications and/or over-the-counter medications for acute and
semi-acute medical conditions 15 days prior to Day 1 and for the duration of the
study. Use of acetaminophen is permitted on an as-needed basis.

- Use of an investigational drug or participation in an investigational study within 30
days prior to Day 1 and for the duration of the study.

- Use of oral or injectable corticosteroids within 30 days prior to Day 1 and for the
duration of the study.

- Use of anticoagulant medications (heparin compounds, platelet inhibitors or warfarin)
within 30 days prior to Day 1 and for the duration of the study. Use of aspirin 81 mg
or 325 mg once daily is permitted.

- Use of neuro-active prescription medications specifically major and atypical
antipsychotic medications within 30 days prior to Day 1 and for the duration of the
study.

- Use of prescription medications, over-the-counter medications, medical foods, and
nutritional supplements for the treatment of hyperlipidemia within 30 days prior to
Day 1 and for the duration of the study.

- Use of prescription medications, over-the-counter medications, medical foods, and
nutritional supplements for the treatment of hyperglycemia within 30 days prior to Day
1 and for the duration of the study.