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

Nature's Sunshine Products

Status: Completed

Conditions: Gastrointestinal Symptoms

Treatments: Other: Prog: Purify-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03685552

NSP-CT-012

Details and patient eligibility

About

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

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Prog: Purify-2

Experimental group

Description:

All subjects will be participating in a diet life style modification program (High Phytopro dietary program) ( a modified Mediterranean style low glycemic load food plan) and will be receiving a supportive nutritional supplements over a 4 week period.

Treatment:

Other: Prog: Purify-2