Microbial ColonizationTRIUMPHNCT06023940
Variability in Microbial Response to Dietary Fiber
A study testing High fiber in people with Microbial Colonization, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The goal of this clinical trial is to understand varying in responses to different dietary patterns in healthy people who are getting a health screening colonoscopy. The main questions it aims to answer are: What is the variability in the change of the microbes in the gut of (1) a provided diet that is high in fiber… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- High fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 31 Oct 2023
- Phase
- Interventional
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Age 45-65y: the average age of people referred for a screening colonoscopy
- BMI ≥20.0 or ≤40.0 kg/m2
- Weight stable: no fluctuations in body weight of greater than 4 kg in the last 3 months
- Scheduled for a health-screening colonoscopy
- Willingness to consume a high-fiber diet
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- Willing to provide blood and fecal samples
- Healthy or have one or more characteristics of the metabolic syndrome (but not diabetic) Metabolic syndrome criteria
- A large waistline: 35 inches or more for women 40 inches or more for men
- High triglycerides: 150 mg/dL or higher
- Low HDLc level: <50 mg/dL for women <40 mg/dL for men
- High blood pressure ≥130/85 mmHg
- Fasting blood sugar ≥100 mg/dL - Pre-diabetes acceptable (glucose <125 mg/dL or HbA1c <6.5%)
- Subjects are also eligible if they are stably treated with statin drugs, anti-hypertensive medications, and anti-depressants. These are eligible as long as the drug category does not alter appetite, body weight, or the microbiome (if known).
Who cannot join
- Pregnant or lactating, or planning to become pregnant
- BMI of <20.0 or >40.0 kg/m2
- Use of tobacco products
- Uncontrolled hypertension and blood pressure ≥ 180/110
- Use of medications that affect the gut microbiome (e.g., antibiotics)
- Taking medications known to affect appetite (phentermine) or gastrointestinal function (e.g. metformin)
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- On a special diet vegetarian, or other restricted dietary patterns
- Undergoing weight loss
- Ad libitum intake of fiber above 25 g/day (mean intake in the US population is 17 g/day) and also an intake of fiber <10 g/d
- Ad libitum alcohol intake of greater than 7 drinks/week for women and 14 drinks/week for men
- History of disease (example colon cancer, etc.)
- Live more than 45 miles away from the University because participants will need to come into the Lab every 3 days or so to pick up meals.
- Control Arm Inclusion criteria
- Men and women
- Age 45-65y: the average age of people referred for a screening colonoscopy
- Scheduled for a health-screening colonoscopy
- Willing to provide fecal samples
- Subjects are also eligible if they are stably treated with statin drugs, anti-hypertensive medications, and anti-depressants. These are eligible as long as the drug category does not alter appetite, body weight, or the microbiome (if known).
- Pregnant or lactating, or planning to become pregnant
- Use of medications that affect the gut microbiome (e.g., antibiotics within the past 30 days)
- History of disease (example colon cancer, active GI bleeding, inflammatory bowel disease, etc.)
- Live more than 45 miles away from the University because participants will need to come into the Lab every 3 days or so to deliver fecal samples.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to understand varying in responses to different dietary patterns in healthy people who are getting a health screening colonoscopy.
The main questions it aims to answer are:
Read more
- What is the variability in the change of the microbes in the gut of (1) a provided diet that is high in fiber vs (2) a diet of the participant's choice.
- What is the magnitude of fasting changes in glucose and lipids following the short-term, high-fiber feeding period and identify candidate predictive factors (short-chain fatty acids, BMI, sex, starting glucose level) for these changes
Participants will be in one of two groups:
- High-fiber diet group: These participants will have a series of measurements that include: blood biochemistries, body composition measured via DEXA, anthropometrics, surveys and questionnaires, and collection of fecal samples.
- Normal diet group: These participants will eat a diet that is of their choosing (ad libitum) and will have a series of measurements that include: fecal samples, and questionnaires/surveys including food records.
Read the detailed description
Fiber fermentation in the colon produces short chain fatty acids (SCFA) and alters the microbial composition and activity. These effects may be mechanisms linking a high-fiber diet to improved health. However, different people may respond to dietary fiber differently and the variability in early, dietary-induced SCFA concentration changes has not been established. This lack of basic understanding in individual patterns of microbial SCFA production significantly limits efforts in the field of Precision Nutrition designed to target dietary strategies to improve health and advance lifestyle treatments in healthcare in the future. In this project, the central hypothesis is that the mechanisms by which dietary fiber provide metabolic benefits include a direct physical effect to improve fasting glucose and lipids and an effect related to increasing SCFA concentration. These are the ideas being tested in this study.
Using fiber derived from peas in a two-week human feeding intervention, Aim 1 will quantitate the variability in high-fiber-induced change in microbial composition and SCFA production by specifically testing the hypothesis that Following successful colonoscopy bowel prep, variability in the reduction in microbial species will be very small, while repopulation after a standardized high-fiber diet will be characterized by larger differences between individuals with regard to the quantity of bifidobacterial and the Firmicutes/ Bacteroidetes ratio.
Aim 2 will quantitate the magnitude of fasting changes in glucose and lipids following the short-term, high-fiber feeding period and identify candidate predictive factors (SCFA, BMI, sex, starting glucose level) for these changes by testing the hypothesis that a two-week, high-fiber diet will result in lower plasma glycemia and triglycerides. Participants (n=30) who have undergone a health-screening colonoscopy (HSC) are fed a high-fiber diet for 14 days. Fecal samples are collected before the colonoscopy and on days 1, 7 and 14 after the colonoscopy during high-fiber feeding. On day 1 and 14, the subject visits the clinical unit for a fasting blood draw (for measurement of glucose, lipids, and plasma SCFA), surveys and questionnaires.
A control arm will also be included as part of this study. The purpose of the control arm is to quantitate the variability in microbial composition and SCFA production from an ad libitum diet of participants. Instead of providing a high-fiber diet, the repopulation of the gut microbiome will be observed when participants eat a diet that is of their choosing. A series of food records and fecal samples pre- and post-procedure will be collected. Figure 2 shows the protocol of this arm. Food records will be collected: pre-procedure, days 0 (procedure day), 1, 2, 4, 7, 10, 13. Fecal collection will be collected: pre-procedure, 3, 5, 8, 11, 14. This arm will not include the blood collection or DEXA scan.
- Conditions
- Microbial Colonization
- Being tested
- High fiber
- Keywords
- colonoscopy, fiber
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fiberDietary supplement
A pea fiber supplement is added to a diet of regular foods. Participants receive 25g fiber daily.
| Study group | Role | What they receive |
|---|---|---|
| High Fiber | Experimental | Subjects are provided a high-fiber diet for 2 weeks. Tests include: blood biochemistries, body composition measured via DEXA, fecal sample collection, and anthropometrics measured Receives: Dietary Supplement: High fiber |
| Control | No intervention | Subjects are not provided any diet, instead they eat what they choose for two weeks while they participate in a series of tests including: fecal sampling, food records, questionnaires/surveys, and anthropometrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability in microbial composition as measured by 'alpha diversity'
Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14).
Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14).
Variability in microbial composition refers to how many different kinds of microbes are present in the fecal sample. We are testing the possibility that the more kinds of microbes, the healthier the person. The higher the measure the alpha diversity, the greater the number of different microbes.
Measured: 2 weeks
Concentration of SCFA
Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14).
Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14).
Measured: 2 weeks
Secondary outcomes (2)
Blood glucose concentration (mg/dL)
Measure changes in fasting blood glucose concentration following the short-term, high-fiber feeding period. Blood taken at screening, baseline, and follow up.
Measured: 2 weeks
Blood lipid concentation (total cholesterol, LDLc, HDLc) (mg/dL)
Measure changes in fasting blood lipid concentration (mg/dL) following the short-term, high-fiber feeding period. Blood taken at screening, baseline, and follow up.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start12 May 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Treatment group: 2 week high fiber diet Control group: no diet provided, subjects eat whatever they want
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Jane Parks, University of Missouri-Columbia
- Investigators
- Elizabeth Parks, Principal investigator, University of Missouri-ColumbiaYezaz Ghouri, MD, Principal investigator, University of Missouri-ColumbiaKatherene Anguah, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023940
- Sponsor's protocol ID
- 2053546
- Acronym
- TRIUMPH
- Status last verified
- Jul 2024
- First submitted
- 4 May 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability in Microbial Response to Dietary Fiber
- ClinicalTrials.gov ID
- NCT06023940
- Acronym / sponsor ID
- TRIUMPH / 2053546
- Conditions
- Microbial Colonization
- Keywords
- colonoscopy, fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Sep 2023 (actual)
- 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.
The goal of this clinical trial is to understand varying in responses to different dietary patterns in healthy people who are getting a health screening colonoscopy.
The main questions it aims to answer are:
- What is the variability in the change of the microbes in the gut of (1) a provided diet that is high in fiber vs (2) a diet of the participant's choice.
- What is the magnitude of fasting changes in glucose and lipids following the short-term, high-fiber feeding period and identify candidate predictive factors (short-chain fatty acids, BMI, sex, starting glucose level) for these changes
Participants will be in one of two groups:
- High-fiber diet group: These participants will have a series of measurements that include: blood biochemistries, body composition measured via DEXA, anthropometrics, surveys and questionnaires, and collection of fecal samples.
- Normal diet group: These participants will eat a diet that is of their choosing (ad libitum) and will have a series of measurements that include: fecal samples, and questionnaires/surveys including food records.
Detailed description
Fiber fermentation in the colon produces short chain fatty acids (SCFA) and alters the microbial composition and activity. These effects may be mechanisms linking a high-fiber diet to improved health. However, different people may respond to dietary fiber differently and the variability in early, dietary-induced SCFA concentration changes has not been established. This lack of basic understanding in individual patterns of microbial SCFA production significantly limits efforts in the field of Precision Nutrition designed to target dietary strategies to improve health and advance lifestyle treatments in healthcare in the future. In this project, the central hypothesis is that the mechanisms by which dietary fiber provide metabolic benefits include a direct physical effect to improve fasting glucose and lipids and an effect related to increasing SCFA concentration. These are the ideas being tested in this study.
Using fiber derived from peas in a two-week human feeding intervention, Aim 1 will quantitate the variability in high-fiber-induced change in microbial composition and SCFA production by specifically testing the hypothesis that Following successful colonoscopy bowel prep, variability in the reduction in microbial species will be very small, while repopulation after a standardized high-fiber diet will be characterized by larger differences between individuals with regard to the quantity of bifidobacterial and the Firmicutes/ Bacteroidetes ratio.
Aim 2 will quantitate the magnitude of fasting changes in glucose and lipids following the short-term, high-fiber feeding period and identify candidate predictive factors (SCFA, BMI, sex, starting glucose level) for these changes by testing the hypothesis that a two-week, high-fiber diet will result in lower plasma glycemia and triglycerides. Participants (n=30) who have undergone a health-screening colonoscopy (HSC) are fed a high-fiber diet for 14 days. Fecal samples are collected before the colonoscopy and on days 1, 7 and 14 after the colonoscopy during high-fiber feeding. On day 1 and 14, the subject visits the clinical unit for a fasting blood draw (for measurement of glucose, lipids, and plasma SCFA), surveys and questionnaires.
A control arm will also be included as part of this study. The purpose of the control arm is to quantitate the variability in microbial composition and SCFA production from an ad libitum diet of participants. Instead of providing a high-fiber diet, the repopulation of the gut microbiome will be observed when participants eat a diet that is of their choosing. A series of food records and fecal samples pre- and post-procedure will be collected. Figure 2 shows the protocol of this arm. Food records will be collected: pre-procedure, days 0 (procedure day), 1, 2, 4, 7, 10, 13. Fecal collection will be collected: pre-procedure, 3, 5, 8, 11, 14. This arm will not include the blood collection or DEXA scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment group: 2 week high fiber diet Control group: no diet provided, subjects eat whatever they want
| Arm | Type | Receives |
|---|---|---|
| High Fiber | Experimental | Dietary Supplement: High fiberSubjects are provided a high-fiber diet for 2 weeks. Tests include: blood biochemistries, body composition measured via DEXA, fecal sample collection, and anthropometrics measured |
| Control | No intervention | –Subjects are not provided any diet, instead they eat what they choose for two weeks while they participate in a series of tests including: fecal sampling, food records, questionnaires/surveys, and anthropometrics |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women
- Age 45-65y: the average age of people referred for a screening colonoscopy
- BMI ≥20.0 or ≤40.0 kg/m2
- Weight stable: no fluctuations in body weight of greater than 4 kg in the last 3 months
- Scheduled for a health-screening colonoscopy
Key exclusion criteria (22 listed)
- Pregnant or lactating, or planning to become pregnant
- BMI of <20.0 or >40.0 kg/m2
- Use of tobacco products
- Uncontrolled hypertension and blood pressure ≥ 180/110
- Use of medications that affect the gut microbiome (e.g., antibiotics)
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 |
|---|---|---|
| High fiberA pea fiber supplement is added to a diet of regular foods. Participants receive 25g fiber daily. | Dietary supplement | High Fiber |
Primary outcome
Variability in microbial composition as measured by 'alpha diversity'
Time frame: 2 weeks
Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14). Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14). Variability in microbial composition refers to how many different kinds of microbes are present in the fecal sample. We are testing the possibility that the more kinds of microbes, the healthier the person. The higher the measure the alpha diversity, the greater the number of different microbes.
Concentration of SCFA
Time frame: 2 weeks
Measured via fecal sample. Intervention group - measured once before scheduled health screening colonoscopy and 2 times over 2 weeks post-colonoscopy (day 1, 7, 14). Control group - measured once before scheduled health screening colonoscopy and 5 days over 2 weeks post-colonoscopy (day 3, 5, 8, 11, 14).
2 secondary outcomes
Blood glucose concentration (mg/dL)
Time frame: 2 weeks
Blood lipid concentation (total cholesterol, LDLc, HDLc) (mg/dL)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Elizabeth Parks principal investigator
University of Missouri-Columbia
Yezaz Ghouri, MD principal investigator
University of Missouri-Columbia
Katherene Anguah, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fiber in people with Microbial Colonization, run by University of Missouri-Columbia 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 14 inclusion and 22 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: finished, as of the sponsor's last update on 24 Jul 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability in microbial composition as measured by 'alpha diversity' (time frame: 2 weeks). 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 24 Jul 2024.