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

Completed · Not applicable

Conditions studied: Gastrointestinal Symptoms

In brief

The study evaluated the safety, tolerability and acceptability of a lifestyle modification program with nutritional supplementation designed to restore balance to healthy bowel function in generally healthy subjects

Key facts

Study ID

NCT03685552

Run by

Nature's Sunshine Products, Inc.

People needed

38

Starts

2017-08-03

Expected to finish

2017-09-13

Last updated by the study team

2018-09-26

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Hughes Center for Research and Innovation — Lehi, Utah, United States

Full record on ClinicalTrials.gov

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