Clinical trial NCT03685552: Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0
Official title: Safety Evaluation of a Diet and Nutritional Supplementation Program for Support of Balanced Bowel Function in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Symptoms
Lead sponsor: Nature's Sunshine Products, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in Quality of life questionnaire [Medical Outcomes Study-Short Form 36 (MOS-SF36)] compared to baseline
timeFrame: 4 weeks
measure: Changes in gastrointestinal Quality of Life questionnaire with Bristol Stool Chart scores compared to baseline
timeFrame: 4 weeks
measure: Changes in Medical Symptom Questionnaire compared to baseline
timeFrame: 4 weeks
measure: Number of participants with treatment-related changes in basic safety labs
timeFrame: 4 weeks
measure: Changes in blood pressure and peripheral pulse compared to baseline
timeFrame: 4 weeks
measure: Changes in weight in pounds compared to baseline
timeFrame: 4 weeks
measure: Changes in body fat in percentage compared to baseline
timeFrame: 4 weeks
measure: Changes in body mass index (BMI) in kg/m2 compared to baseline
timeFrame: 4 weeks
measure: Changes in waist circumference in inches compared to baseline
timeFrame: 4 weeks
measure: Changes in lipid panel compared to baseline
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
measure: Changes in Gammaglutamyl transferase (GGT) in U/L compared to baseline
timeFrame: 4 weeks
measure: Changes in fasting Glucose and Insulin compared to baseline
timeFrame: 4 weeks
measure: Changes in inflammatory markers levels including calprotectin, secretory Immunoglobulin A (IgA), and eosinophil-derived neurotoxin
timeFrame: 4 weeks
measure: Changes in myeloperoxidase (MPO) levels compared to baseline
timeFrame: 4 weeks
measure: Changes in Heme Oxygenase-1 (HO-1) levels in ng/ml compared to baseline
timeFrame: 4 weeks
measure: Changes in total branch chain amino acids levels compared to baseline
timeFrame: 4 weeks
measure: Changes in Trimethylamine N-oxide/ Asymmetric dimethylarginine/ Symmetric dimethylarginine (TMAO/ADMA/SDMA) levels compared to baseline
timeFrame: 4 weeks
measure: Changes in sodium copper chlorophyllin levels compared to baseline
timeFrame: 4 weeks
measure: Changes in metallothionein protein levels compared to baseline
timeFrame: 4 weeks
measure: Changes in Thiobarbituric acid (TBARS/Malondialdehyde) compared to baseline
timeFrame: 4 weeks
measure: Changes in Total Antioxidant Capacity (TAC) levels as Trolox Equivalent (TE) compared to baseline
timeFrame: 4 weeks
measure: Changes in serum Zonulin levels compared to baseline
timeFrame: 4 weeks
measure: Changes in Lactulose/Mannitol ratio in 24-hour urine collected samples compared to baseline
timeFrame: 4 weeks
measure: Changes in urine toxic element levels compared to baseline
timeFrame: 4 weeks
measure: Changes in stool Zonulin levels compared to baseline
timeFrame: 4 weeks
measure: Changes in stool short chain fatty acids (SCFAs) levels including n-butyrate, propionate and acetate compared to baseline
timeFrame: 4 weeks
measure: Changes in stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio compared to baseline
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lehi
country: United States
facility: The Hughes Center for Research and Innovation
state: Utah
Study officials:
affiliation: Hughes Center for Research and Innovation
name: Joseph J Lamb, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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, 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.
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.