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

Nature's Sunshine Products, Inc.38 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastrointestinal Symptoms

Interventions

Prog: Purify-2OTHER

Nutritional Supplements to be administered: * Protein Shakes: one protein shake twice a day * Probiotics (Bacillus Coagulans) once a day * Biome NO+ ( blend of amino acids, specifically l-arginine and l-citrulline, combined with red beet root, grape polyphenol extract, vitamins and minerals) twice a day * In.Form Purify ( blend of psyllium hull, inulin, L-glutamine, fruit, fruit extracts and zinc) twice a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Hughes Center for Research and Innovation

Lehi, Utah, United States

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).

Data collection at individual and group visits and physician interviews at individual visits (baseline, week 1, week 2 and week 4) will be used to assess participants for treatment-related adverse events. Subjects with ongoing AEs may be followed for an additional 4 weeks at the discretion of the PI.

Time frame: 4 weeks

Secondary Outcomes

Changes in Quality of life questionnaire [Medical Outcomes Study-Short Form 36 (MOS-SF36)] compared to baseline

The clinician will review the Medical Outcomes Study-Short Form 36 (MOS-SF36)\] at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in gastrointestinal Quality of Life questionnaire with Bristol Stool Chart scores compared to baseline

The clinician will review the Gastrointestinal Quality of Life questionnaire with Bristol Stool Chart scores at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in Medical Symptom Questionnaire compared to baseline

The clinician will review the Medical Symptom Questionnaire at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Number of participants with treatment-related changes in basic safety labs

Phlebotomy will be conducted at individual visits (baseline, week 1, week 2 and week 4). Comprehensive Metabolic Panels (CMP) including ALT (Alanine aminotransferase), AST(aspartate aminotransferase) and Complete Blood Counts (CBC) will be assessed for treatment-related change from baseline.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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Changes in blood pressure and peripheral pulse compared to baseline

Blood pressure and peripheral pulse will be monitored at individual visits (baseline, week 1, week 2 and week 4).

Changes in weight in pounds compared to baseline

Weight in pounds will be monitored at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in body fat in percentage compared to baseline

Body fat in percentage will be monitored at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in body mass index (BMI) in kg/m2 compared to baseline

Body mass will be monitored at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in waist circumference in inches compared to baseline

Body mass will be monitored at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in lipid panel compared to baseline

Lipid panel will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in inflammatory marker (high sensitivity C-reactive protein (hs-CRP) in mg/L) to identify low levels of inflammation that can be associated with conditions like cardiovascular disease compared to baseline

hs-CRP will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in Gammaglutamyl transferase (GGT) in U/L compared to baseline

GGT will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in fasting Glucose and Insulin compared to baseline

Glucose and Insulin will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in inflammatory markers levels including calprotectin, secretory Immunoglobulin A (IgA), and eosinophil-derived neurotoxin

Calprotectin, secretory IgA, and eosinophil-derived neurotoxin will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in myeloperoxidase (MPO) levels compared to baseline

MPO will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in Heme Oxygenase-1 (HO-1) levels in ng/ml compared to baseline

(HO-1) will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in total branch chain amino acids levels compared to baseline

Total branch amino acids will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in Trimethylamine N-oxide/ Asymmetric dimethylarginine/ Symmetric dimethylarginine (TMAO/ADMA/SDMA) levels compared to baseline

TMAO/ADMA/SDMA will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in sodium copper chlorophyllin levels compared to baseline

Chlorophyllin will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in metallothionein protein levels compared to baseline

Metallothionein will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in Thiobarbituric acid (TBARS/Malondialdehyde) compared to baseline

TBARS will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in Total Antioxidant Capacity (TAC) levels as Trolox Equivalent (TE) compared to baseline

TAC will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in serum Zonulin levels compared to baseline

Zonulin will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in Lactulose/Mannitol ratio in 24-hour urine collected samples compared to baseline

Lactulose/Mannitol ratio will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in urine toxic element levels compared to baseline

Toxic element levels will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in stool Zonulin levels compared to baseline

Stool Zonulin will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in stool short chain fatty acids (SCFAs) levels including n-butyrate, propionate and acetate compared to baseline

SCFAs levels will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks

Changes in stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio compared to baseline

stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio will be measured at individual visits (baseline, week 1, week 2 and week 4).

Time frame: 4 weeks