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

September 24, 2018 updated by: Nature's Sunshine Products, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
4 weeks
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).
4 weeks
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 weeks
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.
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks
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).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nature's Sunshine Products, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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