Type II DiabetesEarly Phase 1NCT02974699
Role of Gastrointestinal Microbes on Digestion of Resistant Starch and Tryptophan Availability to Humans
A Early Phase 1 study testing Potato Starch (Bob's Red Mill) and Pregelatinized Starch (Resource ThickenUp) in people with Type II Diabetes, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Potato Starch (Bob's Red Mill) and Pregelatinized Starch (Resource ThickenUp)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female
- Age 18 - 65 years old
- Non-Obese (BMI ≤ 30 kg/m2 and >17 kg/m2 )
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wayne State University
Detroit, Michigan, 48202
Paul Burghardt, 313-577-0107, paul.burghardt@wayne.edu
About this study
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.
- Conditions
- Type II Diabetes
- Being tested
- Potato Starch (Bob's Red Mill), Pregelatinized Starch (Resource ThickenUp)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato Starch (Bob's Red Mill)Dietary supplement
Subjects will be assigned to Potato Starch (active) following assessment of their gut microbiome.
Pregelatinized Starch (Resource ThickenUp)Dietary supplement
Subjects will be assigned to Pregelatinized Starch (placebo) following assessment of their gut microbiome.
| Study group | Role | What they receive |
|---|---|---|
| Potato Starch (Bob's Red Mill) | Experimental | Daily dietary supplementation with Potato Starch (48g total/day) suspended in water. 24g will be consumed 2 times per day. Receives: Dietary Supplement: Potato Starch (Bob's Red Mill) |
| Resource ThickenUp Pregelatinized Starch | Placebo comparator | Daily dietary supplementation with Pregelatinized Starch (48g total/day) suspended in water. 24g will be consumed 2 times per day. Receives: Dietary Supplement: Pregelatinized Starch (Resource ThickenUp) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Amino Acid Levels
Measured: Baseline
Plasma Amino Acid Levels
Measured: Following 4 weeks of supplementation
Secondary outcomes (1)
Change in Plasma Amino Acid Levels
Difference in plasma amino acid levels between baseline and following 4-weeks of supplementation
Measured: Baseline vs. 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Burghardt, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974699
- Sponsor's protocol ID
- 110116M1F
- Status last verified
- May 2017
- First submitted
- 21 Nov 2016
- Last updated
- 4 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gastrointestinal Microbes on Digestion of Resistant Starch and Tryptophan Availability to Humans
- ClinicalTrials.gov ID
- NCT02974699
- Acronym / sponsor ID
- 110116M1F
- Conditions
- Type II Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potato Starch (Bob's Red Mill) | Experimental | Dietary Supplement: 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. |
| Resource ThickenUp Pregelatinized Starch | Placebo comparator | Dietary Supplement: Pregelatinized Starch (Resource ThickenUp)Daily dietary supplementation with Pregelatinized Starch (48g total/day) suspended in water. 24g will be consumed 2 times per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female
- Age 18 - 65 years old
- Non-Obese (BMI ≤ 30 kg/m2 and >17 kg/m2 )
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potato Starch (Bob's Red Mill)Subjects will be assigned to Potato Starch (active) following assessment of their gut microbiome. | Dietary supplement | Potato Starch (Bob's Red Mill) |
| Pregelatinized Starch (Resource ThickenUp)Subjects will be assigned to Pregelatinized Starch (placebo) following assessment of their gut microbiome. | Dietary supplement | Resource ThickenUp Pregelatinized Starch |
Primary outcome
Plasma Amino Acid Levels
Time frame: Baseline
Plasma Amino Acid Levels
Time frame: Following 4 weeks of supplementation
1 secondary outcome
Change in Plasma Amino Acid Levels
Time frame: Baseline vs. 4-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Potato Starch (Bob's Red Mill) and Pregelatinized Starch (Resource ThickenUp) in people with Type II Diabetes, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul R Burghardt, PhD (3135770107, paul.burghardt@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Amino Acid Levels (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.