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Role of Gastrointestinal Microbes on Digestion of Resistant Starch and Tryptophan Availability to Humans

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ClinicalTrials.gov Identifier: NCT02974699
Recruitment Status : Unknown
Verified May 2017 by Paul Burghardt, Wayne State University.
Recruitment status was:  Recruiting
First Posted : November 28, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Burghardt, Wayne State University

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE November 28, 2016
Last Update Posted Date May 4, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • Plasma Amino Acid Levels [ Time Frame: Baseline ]
  • Plasma Amino Acid Levels [ Time Frame: Following 4 weeks of supplementation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
Change in Plasma Amino Acid Levels [ Time Frame: Baseline vs. 4-weeks ]
Difference in plasma amino acid levels between baseline and following 4-weeks of supplementation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Gastrointestinal Microbes on Digestion of Resistant Starch and Tryptophan Availability to Humans
Official Title  ICMJE Not Provided
Brief Summary There is currently a critical gap in knowledge of how intestinal bacterial communities alter metabolic substrates available to the host thereby influencing central and enteric nervous system (CNS/ENS) neurotransmitter levels involved in regulating carbohydrate consumption in humans. Understanding these relationships is essential for developing strategies to improve blood glucose control and to reduce the risk of transitioning from prediabetes to type-2 diabetes (T2D). The investigators' long-term goal is to determine the biological underpinnings of behaviors that impact food intake and blood glucose control that contribute to the development of T2D. The objective of this proposal, which is an essential next step in attaining the investigators' long-term goals, is to determine how bacterial populations in the digestive system impact circulating tryptophan (TRP) and large neutral amino acid (LNAA) levels that regulate production of monoamine 5-hydroxytryptamine (5-HT, serotonin) in the ENS and in gastrointestinal system and the brain. The central hypothesis is that a reduced ratio of TRP producing (TRPp) to TRP consuming (TRPc) bacteria (decreased TRPp:TRPc ratio) in the gut will decrease TRP availability following a carbohydrate meal lowering the plasma TRP:LNAA ratio and resulting in less TRP for ENS/CNS production of 5HT. Further, dietary interventions that promote TRPp bacterial abundance within the gut will increase TRP availability to the host. The investigators will test the central hypothesis and, thereby, accomplish the overall objective for this project by pursuing the following specific aims: 1) Assess impact of divergent microbiota on plasma TRP:LNAA ratio in response to acute carbohydrate consumption, and 2) Assess the impact of dietary supplementation with resistant starch (RS) on gut microbiota and circulating TRP:LNAA ratio. During Aim 1, stool samples will be collected from healthy participants. Participants will be stratified based on gut TRPp:TRPc ratio and the response to an acute meal will be assessed by determining plasma TRP:LNAA ratios. During Aim 2 the capacity for 4-weeks of pre-biotic RS (Potato Starch) supplementation to increase the TRPp:TRPc bacterial ratio in the gut will be determined from stool samples. Additionally, plasma TRP:LNAA ratio following acute carbohydrate consumption before and after supplementation will be determined. The scientific contribution will be to determine the impact of RS on TRPp and TRPc bacteria abundance in the gut, and how bacterial populations impact circulating TRP:LNAA levels, that can impact ENS and CNS 5HT production in humans. This contribution will be significant because it will have direct translational implications for human diseases with altered 5HT signaling.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Type II Diabetes
Intervention  ICMJE
  • Dietary Supplement: Potato Starch (Bob's Red Mill)
    Subjects will be assigned to Potato Starch (active) following assessment of their gut microbiome.
  • Dietary Supplement: Pregelatinized Starch (Resource ThickenUp)
    Subjects will be assigned to Pregelatinized Starch (placebo) following assessment of their gut microbiome.
Study Arms  ICMJE
  • Experimental: Potato Starch (Bob's Red Mill)
    Daily dietary supplementation with Potato Starch (48g total/day) suspended in water. 24g will be consumed 2 times per day.
    Intervention: Dietary Supplement: Potato Starch (Bob's Red Mill)
  • Placebo Comparator: Resource ThickenUp Pregelatinized Starch
    Daily dietary supplementation with Pregelatinized Starch (48g total/day) suspended in water. 24g will be consumed 2 times per day.
    Intervention: Dietary Supplement: Pregelatinized Starch (Resource ThickenUp)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 22, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female
  2. Age 18 - 65 years old
  3. Non-Obese (BMI ≤ 30 kg/m2 and >17 kg/m2 )

Exclusion Criteria:

  1. Urine toxicology positive,
  2. Pregnant (female)
  3. Alcohol intake 48 hours prior to studies,
  4. Evidence of inherited disorders of lipid metabolism,
  5. History of Cancer within the last 5 years,
  6. Human immunodeficiency virus (HIV) antibody positive,
  7. Patients with solid organ transplants,
  8. Unstable angina or NY heart association class II failure or above,
  9. Gastrointestinal disease specifically GI motility disorders,
  10. Unstable neuropsychiatric disease including major depression/anxiety, eating disorder such as bulimia or anorexia,
  11. End stage renal or hepatic disease,
  12. Autoimmune disorders (e.g. SLE),
  13. Prior bariatric surgery,
  14. A history or current alcohol/substance abuse or nicotine containing products or illicit drugs of abuse during the preceding 6 months,
  15. Treatment within one month with sedative hypnotic medications (benzodiazepines, barbiturates), or over the counter sleeping aids
  16. Women: any selective estrogen receptor modulator or aromatase inhibitor Men:

    androgen ablation/deprivation hormonal therapies

  17. Any medical condition, which in the opinion of the investigator would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol
  18. Any previous adverse events or allergic reactions to acetaminophen
  19. Unwilling or unable to consent for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02974699
Other Study ID Numbers  ICMJE 110116M1F
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Burghardt, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wayne State University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP