- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974699
Role of Gastrointestinal Microbes on Digestion of Resistant Starch and Tryptophan Availability to Humans
May 1, 2017 updated by: Paul Burghardt, Wayne State University
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paul R Burghardt, PhD
- Phone Number: 3135770107
- Email: paul.burghardt@wayne.edu
Study Contact Backup
- Name: Katlin Chappelle, BS
- Phone Number: 3135772716
- Email: fx3603@wayne.edu
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Wayne State University
-
Contact:
- Paul Burghardt
- Phone Number: 313-577-0107
- Email: paul.burghardt@wayne.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female
- Age 18 - 65 years old
- Non-Obese (BMI ≤ 30 kg/m2 and >17 kg/m2 )
Exclusion Criteria:
- Urine toxicology positive,
- Pregnant (female)
- Alcohol intake 48 hours prior to studies,
- Evidence of inherited disorders of lipid metabolism,
- History of Cancer within the last 5 years,
- Human immunodeficiency virus (HIV) antibody positive,
- Patients with solid organ transplants,
- Unstable angina or NY heart association class II failure or above,
- Gastrointestinal disease specifically GI motility disorders,
- Unstable neuropsychiatric disease including major depression/anxiety, eating disorder such as bulimia or anorexia,
- End stage renal or hepatic disease,
- Autoimmune disorders (e.g. SLE),
- Prior bariatric surgery,
- A history or current alcohol/substance abuse or nicotine containing products or illicit drugs of abuse during the preceding 6 months,
- Treatment within one month with sedative hypnotic medications (benzodiazepines, barbiturates), or over the counter sleeping aids
Women: any selective estrogen receptor modulator or aromatase inhibitor Men:
androgen ablation/deprivation hormonal therapies
- 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
- Any previous adverse events or allergic reactions to acetaminophen
- Unwilling or unable to consent for the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Subjects will be assigned to Potato Starch (active) following assessment of their gut microbiome.
|
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.
|
Subjects will be assigned to Pregelatinized Starch (placebo) following assessment of their gut microbiome.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma Amino Acid Levels
Time Frame: Baseline
|
Baseline
|
Plasma Amino Acid Levels
Time Frame: Following 4 weeks of supplementation
|
Following 4 weeks of supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline vs. 4-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (ANTICIPATED)
December 1, 2017
Study Registration Dates
First Submitted
November 21, 2016
First Submitted That Met QC Criteria
November 22, 2016
First Posted (ESTIMATE)
November 28, 2016
Study Record Updates
Last Update Posted (ACTUAL)
May 4, 2017
Last Update Submitted That Met QC Criteria
May 1, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110116M1F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type II Diabetes
-
Microbio Co LtdCompleted
-
pico-tesla Magnetic Therapies, LLCCompletedType II Diabetes MellitusUnited States
-
KeyBioscience AGEli Lilly and Company; Profil Institut für Stoffwechselforschung GmbH; Nordic...TerminatedType II Diabetes MellitusGermany
-
HealthInsightCenter for Technology and Aging; VoxivaUnknownType II Diabetes MellitusUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Khoo Teck Puat HospitalCompletedType II Diabetes in Subjects BMI 27 to 32Singapore
-
University of PretoriaNestlè Nutrition Institute Africa; South African Sugar AssociationCompletedDiabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] UncontrolledSouth Africa
-
University of PrimorskaUniversity of Ljubljana School of Medicine, SloveniaCompletedDiabetes Mellitus Type II,Slovenia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
Clinical Trials on Potato Starch (Bob's Red Mill)
-
University of Michigan Rogel Cancer CenterRecruitingHematopoietic Stem Cell TransplantationUnited States
-
University of ManitobaRecruitingChronic Kidney DiseasesCanada
-
Dartmouth-Hitchcock Medical CenterCompleted
-
University of MichiganNot yet recruitingHeart Failure With Preserved Ejection Fraction | Type2diabetesUnited States
-
Medical College of WisconsinCompletedHematologic Diseases | Clostridium DifficileUnited States
-
St. Boniface HospitalManitoba Starch Products; National Microbiology Laboratory, CanadaCompletedFocus of Study; Impact of MSPrebiotic on Gastrointestinal MicrobiotaCanada
-
University of Michigan Rogel Cancer CenterCompleted
-
Manitoba Starch ProductsCompleted
-
Guelph Food Research CentreNutrasource Pharmaceutical and Nutraceutical Services, Inc.Completed
-
Centre de recherche du Centre hospitalier universitaire...Lallemand Health SolutionsCompleted