NCT03685552CompletedNot Applicable
Safety Evaluation of a Diet and Nutritional Supplementation Program for Support of Balanced Bowel Function in Healthy Volunteers
Nature's Sunshine Products, Inc.2 sites in 1 country38 target enrollmentStarted: August 3, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
Study Overview
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Prog: Purify-2 (Other)
Outcomes
Primary Outcomes
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
- Changes in blood pressure and peripheral pulse compared to baseline(4 weeks)
- Changes in total branch chain amino acids levels compared to baseline(4 weeks)
- Changes in Total Antioxidant Capacity (TAC) levels as Trolox Equivalent (TE) compared to baseline(4 weeks)
- Changes in serum Zonulin levels compared to baseline(4 weeks)
- Changes in weight in pounds compared to baseline(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(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)
- Changes in lipid panel compared to baseline(4 weeks)
- Changes in Gammaglutamyl transferase (GGT) in U/L compared to baseline(4 weeks)
- Changes in inflammatory markers levels including calprotectin, secretory Immunoglobulin A (IgA), and eosinophil-derived neurotoxin(4 weeks)
- Changes in Thiobarbituric acid (TBARS/Malondialdehyde) compared to baseline(4 weeks)
- Changes in waist circumference in inches compared to baseline(4 weeks)
- Changes in Quality of life questionnaire [Medical Outcomes Study-Short Form 36 (MOS-SF36)] compared to baseline(4 weeks)
- Number of participants with treatment-related changes in basic safety labs(4 weeks)
- Changes in body fat in percentage compared to baseline(4 weeks)
- Changes in body mass index (BMI) in kg/m2 compared to baseline(4 weeks)
- Changes in fasting Glucose and Insulin compared to baseline(4 weeks)
- Changes in myeloperoxidase (MPO) levels compared to baseline(4 weeks)
- Changes in Heme Oxygenase-1 (HO-1) levels in ng/ml compared to baseline(4 weeks)
- Changes in Trimethylamine N-oxide/ Asymmetric dimethylarginine/ Symmetric dimethylarginine (TMAO/ADMA/SDMA) levels compared to baseline(4 weeks)
- Changes in metallothionein protein levels compared to baseline(4 weeks)
- Changes in Lactulose/Mannitol ratio in 24-hour urine collected samples compared to baseline(4 weeks)
- Changes in urine toxic element levels compared to baseline(4 weeks)
- Changes in stool short chain fatty acids (SCFAs) levels including n-butyrate, propionate and acetate compared to baseline(4 weeks)
- Changes in sodium copper chlorophyllin levels compared to baseline(4 weeks)
- Changes in stool Zonulin levels compared to baseline(4 weeks)
- Changes in stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio compared to baseline(4 weeks)
Investigators
Study Sites (2)
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