Natural Products Research

Evaluating Changes in Microbiota Composition and Quality of Life in Irritable Bowel Syndrome: A Randomized, Controlled Trial

Principal Investigator: Ryan Bradley ND, MPH (NUNM)
Clinical Investigator: Nini Callan, ND, MS (NUNM)
Co-Investigator: Jamie Corroon, ND, MPH (NUNM), Mahmoud Ghannoum, PhD; Case Western Reserve University
Study Coordinator: Anders Gundersen, MS (NUNM)

This study is a two-arm, 1:1, randomized, double-blind, placebo-controlled clinical trial. The primary research question to be addressed in this investigation is as follows:  Does a 2’-FL-containing dietary supplement impact stool microbiota composition in adults with IBS? The primary measure for determining potential impacts of the 2’-FL-containing dietary supplement on stool microbiota composition is stool abundance of Faecalibacterium prausnitzii, a commensal intestinal bacteria. Additional measures related to determining potential impacts of the 2’-FL-containing dietary supplement on gut microbiota composition are stool levels of additional commensal intestinal bacteria, measures of intestinal microbial diversity, Bristol Stool Form Scale changes, and IBS symptom questionnaires.

Primary Outcome Measure

  • F. prausnitzii abundance in stool

Secondary Outcome Measures:   

  • Relative abundance of F. prausnitzii in stool 
  • Relative abundance of Bifidobacterium spp. in stool
  • Alpha diversity
  • Beta diversity
  • IBS-Severity Scoring System (IBS-SSS) score 
  • IBS-Adequate Relief from Symptoms (IBS-AR)
  • Bristol Stool Form Scale (BSFS)

Exploratory Outcome Measures:

  • Relative abundance of additional microbiota in stool 
  • Butyric acid
  • Acetic acid
  • Propionic acid
  • Lactic acid
  • Formic acid
  • Valeric acid

Evaluating changes in Epigenetic Methylation from Antiorbital Ionic Calcium in Adults with Atrial Fibrillation (AIC-AF)

Principal Investigators: Ryan Bradley ND, MPH, (NUNM)
Co-Investigators: Paul Lee, PhD, Calcium Bone Health Institute (CBHI), Jamie Corroon, ND, MPH, (NUNM), Nini Callan, ND, MS, (NUNM), Joseph Aslan, PhD, (OHSU)
Biostatistician: Jamie Corroon, ND, MPH, (NUNM)
Study Coordinator: Anders Gundersen, MS (NUNM)

The overarching objectives are to assess mechanistic, epigenetic effects, general clinical tolerance, and adverse effects of an ionized calcium dietary supplement, as compared to placebo, using a randomized, placebo-controlled design for 12 weeks, and during a subsequent open-label, follow-up design for an additional 12 weeks, in individuals with atrial fibrillation.

Primary outcome measure: Rate of aging using the Dunedin (P)ace of (A)ging  (C)alculated from the (E)pigenome (i.e., DunedinPACE) epigenetic “speedometer”.

Secondary outcome measure: Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT)

Tertiary outcome measures

  1. Serum ionic calcium – Quest Diagnostic’s Serum Ionic Calcium.
  2. Frequency of fibrillation episodes – KardiaMobile mobile ECG device
  3. Calcification of the coronary arteries – Coronary Artery Calcium score as measured by computerized tomography (optional). 
  4. Bone Densitometry: BeamMed Ltd’s Sunlight MiniOmni Portable Bone Density Scanner; Rayus Radiology DEXA scan (optional).
  5. Bone formation and turnover studies – Quest Diagnostics Inc.’s serum Calcitonin, Osteocalcin, bone-specific Alkaline Phosphatase, Procollagen Type I Intact N Terminal Propeptide (PINP), and Collagen Type I C-Telopeptide (CTx).
  6. Clinical coagulation studies – Quest Diagnostics Inc.’s Prothrombin with INR and Partial Thromboplastin Times
  7. Clinical chemistry studies – Quest Diagnostics Inc.’s Comprehensive Metabolic Panel and Complete Blood Count
  8. Traditional Cardiovascular risk assessment – Quest Diagnostics Inc.’s Standard Lipid Panel 
  9. C-reactive Protein (CRP)
  10. Thyroid screen – Quest Diagnostics Inc.’s Thyroid Stimulating Hormone (TSH).
  11. Platelet assessment — Blood drawn at NUNM into two sodium citrate-prepared vials, analyzed at Dr. Aslan’s OHSU lab.
  12. Adverse effects: NUNM Adverse Event Monitoring Form

Evaluating Changes in Quality of Life and Digestion in Functional Dyspepsia in Adults (QOL- FD)

Principal Investigators: Ryan Bradley ND, MPH, (NUNM)
Clinical Investigator and Co-Investigator: Jamie Corroon, ND, MPH, (NUNM)
Co-Investigator: Mahmoud Ghannoum, PhD; Case Western Reserve University

This study is a 5-week, randomized, triple-blinded, placebo-controlled clinical trial including a 1-week placebo run-in period (i.e., 1 week between enrollment and randomization) and two 4-day controlled feeding periods (i.e., week 1 and week 5). It will investigate the use of a dietary supplement (i.e., Zypan®) containing a proprietary formula of plant and animal-based ingredients over 4 weeks in individuals with Functional Dyspepsia. Participants will be randomized to either: intervention (i.e., Zypan®) or placebo three times daily before meals for 4 weeks.

Xanthohumol Microbiome and Signature in Healthy Adults

Principal Investigators: Ryan Bradley, ND, MPH (NUNM), Jan Frederik Stevens, PhD (OSU), Thomas Metz, PhD (PNNL)

This research is a collaboration between Oregon State University, Pacific Northwest National Laboratory and NUNM. Funded by the National Institutes of Health, this randomized, triple-blind, placebo-controlled trial is designed to assess the impact of Xanthohumol (XN) on gut health. Evidence suggests XN, a polyphenolic compound found in hops, may reduce inflammation in Inflammatory Bowel Disease by reducing gut permeability and increasing the absorption of bile salts. This data will be compared with a subsequent phase two trial in adults with Crohn’s Disease.

This study is currently recruiting participants. For more information please visit here.

Effect of Centella Asiatica on Vascular Function in Older Adults

Principal Investigators: Ben Zimmerman, PhD (NUNM)

The goal of this research is to study whether C. asiatica improves peripheral arterial endothelial function in healthy older adults. The long-term goal is to identify early interventions that improve cognitive function in aging and prevent or postpone age-related dementias.

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