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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prog: Purify-2 | Other | Nutritional Supplements to be administered:
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| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of life questionnaire [Medical Outcomes Study-Short Form 36 (MOS-SF36)] compared to baseline | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph J Lamb, MD | Hughes Center for Research and Innovation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hughes Center for Research and Innovation | Lehi | Utah | 84043 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21568707 | Background | 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. | |
| 18461293 | Background | de Vrese M, Schrezenmeir J. Probiotics, prebiotics, and synbiotics. Adv Biochem Eng Biotechnol. 2008;111:1-66. doi: 10.1007/10_2008_097. |
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | (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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 18215222 | 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. |
| 20920376 | 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. |
| 21717823 | 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. |