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

Gastrointestinal Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685552
• Other study ID #: NSP-CT-012
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: September 13, 2017

Study information

• Verified date: September 2018
• Source: Nature's Sunshine Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 13, 2017
• Est. primary completion date: September 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Symptoms

Intervention

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

Locations

Country	Name	City	State
United States	The Hughes Center for Research and Innovation	Lehi	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Nature's Sunshine Products, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

de Vrese M, Schrezenmeir J. Probiotics, prebiotics, and synbiotics. Adv Biochem Eng Biotechnol. 2008;111:1-66. doi: 10.1007/10_2008_097. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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, Léotoing 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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