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Completed

NCT Number: NCT03685552

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

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

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Key information

Conditions

Gastrointestinal Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hughes Center for Research and Innovation

Lehi, Utah, 84043, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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).

    Time frame: 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 outcomes

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

    Time frame: 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).

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

    Time frame: 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).

  3. Changes in Medical Symptom Questionnaire compared to baseline

    Time frame: 4 weeks

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

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

    Time frame: 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.

  5. Changes in blood pressure and peripheral pulse compared to baseline

    Time frame: 4 weeks

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

  6. Changes in weight in pounds compared to baseline

    Time frame: 4 weeks

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

  7. Changes in body fat in percentage compared to baseline

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

  9. Changes in waist circumference in inches compared to baseline

    Time frame: 4 weeks

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

  10. Changes in lipid panel compared to baseline

    Time frame: 4 weeks

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

  11. 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

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

  13. Changes in fasting Glucose and Insulin compared to baseline

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

  15. Changes in myeloperoxidase (MPO) levels compared to baseline

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

  17. Changes in total branch chain amino acids levels compared to baseline

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

  19. Changes in sodium copper chlorophyllin levels compared to baseline

    Time frame: 4 weeks

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

  20. Changes in metallothionein protein levels compared to baseline

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

  23. Changes in serum Zonulin levels compared to baseline

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

  25. Changes in urine toxic element levels compared to baseline

    Time frame: 4 weeks

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

  26. Changes in stool Zonulin levels compared to baseline

    Time frame: 4 weeks

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

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

    Time frame: 4 weeks

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

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Nature's Sunshine Products, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2018
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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