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

NCT03685552 | Completed DMC

• 1 other identifier: NSP-CT-012
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

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

  4 weeks

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

  4 weeks

• Changes in Medical Symptom Questionnaire compared to baseline

  4 weeks

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

  4 weeks

• Changes in blood pressure and peripheral pulse compared to baseline

  4 weeks

Study Arms (1)

Prog: Purify-2

EXPERIMENTAL

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

Interventions

Prog: Purify-2 OTHER

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

Prog: Purify-2

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nature's Sunshine Products, Inc.: lead

Study Sites (1)

The Hughes Center for Research and Innovation

Lehi, Utah, 84043, United States

Location

Related Publications (5)

• 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.

  PMID: 21568707 BACKGROUND

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

  PMID: 18461293 BACKGROUND

• 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.

  PMID: 18215222 BACKGROUND

• 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.

  PMID: 20920376 BACKGROUND

• 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.

  PMID: 21717823 BACKGROUND

Study Officials

• Joseph J Lamb, MD

  Hughes Center for Research and Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 26, 2018
• Study Start: August 3, 2017
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: September 26, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)