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

Safety Evaluation of a Diet and Nutritional Supplementation Program for Support of Balanced Bowel Function in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Symptoms
• Intervention / Treatment: Other: Prog: Purify-2

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Lehi, Utah, United States, 84043
      • The Hughes Center for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prog: Purify-2; 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.

Other: Prog: Purify-2; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	4 weeks
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).	4 weeks
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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	4 weeks

Collaborators and Investigators

• Sponsor: Nature's Sunshine Products, Inc.

Publications and helpful links

General Publications

• Macfarlane GT, Steed H, Macfarlane S. Bacterial metabolism and health-related effects of galacto-oligosaccharides and other prebiotics. J Appl Microbiol. 2008 Feb;104(2):305-44. doi: 10.1111/j.1365-2672.2007.03520.x.
• Delzenne NM, Cani PD. Interaction between obesity and the gut microbiota: relevance in nutrition. Annu Rev Nutr. 2011 Aug 21;31:15-31. doi: 10.1146/annurev-nutr-072610-145146.
• de Vrese M, Schrezenmeir J. Probiotics, prebiotics, and synbiotics. Adv Biochem Eng Biotechnol. 2008;111:1-66. doi: 10.1007/10_2008_097.
• Roberfroid M, Gibson GR, Hoyles L, McCartney AL, Rastall R, Rowland I, Wolvers D, Watzl B, Szajewska H, Stahl B, Guarner F, Respondek F, Whelan K, Coxam V, Davicco MJ, Leotoing L, Wittrant Y, Delzenne NM, Cani PD, Neyrinck AM, Meheust A. Prebiotic effects: metabolic and health benefits. Br J Nutr. 2010 Aug;104 Suppl 2:S1-63. doi: 10.1017/S0007114510003363.
• Lamb JJ, Konda VR, Quig DW, Desai A, Minich DM, Bouillon L, Chang JL, Hsi A, Lerman RH, Kornberg J, Bland JS, Tripp ML. A program consisting of a phytonutrient-rich medical food and an elimination diet ameliorated fibromyalgia symptoms and promoted toxic-element detoxification in a pilot trial. Altern Ther Health Med. 2011 Mar-Apr;17(2):36-44.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2017
• Primary Completion (Actual): September 13, 2017
• Study Completion (Actual): September 13, 2017

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NSP-CT-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No