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

Not Applicable

Completed

• Conditions: Gastrointestinal Symptoms

• Registration Number: NCT03685552
• Lead Sponsor: Nature's Sunshine Products, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-08-03
• Primary Completion: 2017-09-13
• Study Completion: 2017-09-13
• Status Verified: 2018-09
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-24
• Last Update Submitted: 2018-09-24
• Study First Posted: 2018-09-26
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Changes in blood pressure and peripheral pulse compared to baseline	4 weeks	Blood pressure and peripheral pulse will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Changes in total branch chain amino acids levels compared to baseline	4 weeks	Total branch amino acids will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in Total Antioxidant Capacity (TAC) levels as Trolox Equivalent (TE) compared to baseline	4 weeks	TAC will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in weight in pounds compared to baseline	4 weeks	Weight in pounds will be monitored at individual visits (baseline, week 1, week 2 and week 4).
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	4 weeks	hs-CRP will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in gastrointestinal Quality of Life questionnaire with Bristol Stool Chart scores compared to baseline	4 weeks	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).
Changes in Medical Symptom Questionnaire compared to baseline	4 weeks	The clinician will review the Medical Symptom Questionnaire at individual visits (baseline, week 1, week 2 and week 4).
Changes in lipid panel compared to baseline	4 weeks	Lipid panel will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in Gammaglutamyl transferase (GGT) in U/L compared to baseline	4 weeks	GGT will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in inflammatory markers levels including calprotectin, secretory Immunoglobulin A (IgA), and eosinophil-derived neurotoxin	4 weeks	Calprotectin, secretory IgA, and eosinophil-derived neurotoxin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in Thiobarbituric acid (TBARS/Malondialdehyde) compared to baseline	4 weeks	TBARS will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in serum Zonulin levels compared to baseline	4 weeks	Zonulin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in waist circumference in inches compared to baseline	4 weeks	Body mass will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Changes in Quality of life questionnaire [Medical Outcomes Study-Short Form 36 (MOS-SF36)] compared to baseline	4 weeks	The clinician will review the Medical Outcomes Study-Short Form 36 (MOS-SF36)\] at individual visits (baseline, week 1, week 2 and week 4).
Number of participants with treatment-related changes in basic safety labs	4 weeks	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.
Changes in body fat in percentage compared to baseline	4 weeks	Body fat in percentage will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Changes in body mass index (BMI) in kg/m2 compared to baseline	4 weeks	Body mass will be monitored at individual visits (baseline, week 1, week 2 and week 4).
Changes in fasting Glucose and Insulin compared to baseline	4 weeks	Glucose and Insulin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in myeloperoxidase (MPO) levels compared to baseline	4 weeks	MPO will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in Heme Oxygenase-1 (HO-1) levels in ng/ml compared to baseline	4 weeks	(HO-1) will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in Trimethylamine N-oxide/ Asymmetric dimethylarginine/ Symmetric dimethylarginine (TMAO/ADMA/SDMA) levels compared to baseline	4 weeks	TMAO/ADMA/SDMA will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in metallothionein protein levels compared to baseline	4 weeks	Metallothionein will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in Lactulose/Mannitol ratio in 24-hour urine collected samples compared to baseline	4 weeks	Lactulose/Mannitol ratio will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in urine toxic element levels compared to baseline	4 weeks	Toxic element levels will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in stool short chain fatty acids (SCFAs) levels including n-butyrate, propionate and acetate compared to baseline	4 weeks	SCFAs levels will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in sodium copper chlorophyllin levels compared to baseline	4 weeks	Chlorophyllin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in stool Zonulin levels compared to baseline	4 weeks	Stool Zonulin will be measured at individual visits (baseline, week 1, week 2 and week 4).
Changes in stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio compared to baseline	4 weeks	stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio will be measured at individual visits (baseline, week 1, week 2 and week 4).

Trial Locations

Locations (1)

The Hughes Center for Research and Innovation; 🇺🇸 Lehi, Utah, United States