HealthyNCT04783142
A Study to Evaluate the Influence of Diet on GI Health
A study testing High-fiber, low-protein diet and Low-fiber, high-protein diet in people with Healthy, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to understand the potential of protein and psyllium fiber to manipulate gut microbial densities, intestinal permeability, and inflammation in humans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-fiber, low-protein diet and Low-fiber, high-protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jun 2021to 27 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old
- On a baseline diet characterized by: Fiber intake of </= 20g/day, > 18% of daily calories from protein
Who cannot join
- Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
- Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory GI condition
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
- Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
- Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 6 weeks and for the duration of the study
Show all 17Show fewer
- Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
- Unwilling to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
- Unwilling to stop stenuous exercise (running >5 miles or equivalent) one week prior to the permeability tests
- Bowel preparation for colonoscopy less than one week prior to completion of the first stool kit and permeability test and flexible sigmoidoscopy and upper endoscopy
- Pregnancy or plan to become pregnant during the study time frame
- Vulnerable adult
- Known bleeding disorders or takes medications that increase risk of bleeding from mucosal biopsies
- Use of oral antibiotic(s) within the past 4 weeks (can be enrolled after 4-week washout period)
- Use of commercial probiotic formulations and unwilling to stop for the duration of the study
- Diagnosis of diabetes
- Any other disease(s), condition(s) or habits(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas
The purpose of this study is to understand the potential of protein and psyllium fiber to manipulate gut microbial densities, intestinal permeability, and inflammation in humans.
- Conditions
- Healthy
- Being tested
- High-fiber, low-protein diet, Low-fiber, high-protein diet
- Keywords
- High-Protein, Low-Fiber Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fiber, low-protein dietOther
Diet will consist of at least 15g fiber above baseline and less than 10% of calories from protein.
Low-fiber, high-protein dietOther
Diet will consist of less than 15g fiber and greater than 18% of calories from protein
| Study group | Role | What they receive |
|---|---|---|
| High-fiber, low-protein diet | Other | Participants will consume a high-fiber, low-protein diet for at least 4 weeks. All meals will be provided free of charge. No substitutions will be permitted. Receives: Other: High-fiber, low-protein diet |
| Low-fiber, high-protein diet | Other | Participants will consume a low-fiber, high-protein diet for at least 4 weeks. All meals will be provided free of charge. No substitutions will be permitted. Receives: Other: Low-fiber, high-protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Excretion of Lactulose and 13C-Mannitol
Small Bowel and Colonic Permeability by Urinary Excretion of Lactulose and 13C-Mannitol after Oral Ingestion of lactulose and 13C mannitol (5:1 ratio by mass). The 0-2h urine most closely reflects small intestinal permeability and 8-24h urine reflects colonic permeability. HPLC-tandem mass spectrometry will be used for detection of the sugars. The results will be expressed as the ratio of percentage excretion of the ingested dose of lactulose and mannitol in urine.
Measured: 4 weeks
Secondary outcomes (1)
Change in gut microbial alpha diversity based on Shannon index
Stool samples will be processed to extract DNA, followed by metagenomic sequencing and assessment of alpha diversity using Shannon index. Comparison will be made using ttest.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start11 Jun 2021
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the high-fiber, low protein diet or the low-fiber, high-protein diet.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Purna C. Kashyap, MBBS, Mayo Clinic
- Investigators
- Purna C. Kashyap, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783142
- Sponsor's protocol ID
- 20-008067
- Status last verified
- May 2023
- First submitted
- 23 Feb 2021
- Last updated
- 15 May 2023
- 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 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas
- ClinicalTrials.gov ID
- NCT04783142
- Acronym / sponsor ID
- 20-008067
- Conditions
- Healthy
- Keywords
- High-Protein, Low-Fiber Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 5 Mar 2021 (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 purpose of this study is to understand the potential of protein and psyllium fiber to manipulate gut microbial densities, intestinal permeability, and inflammation in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the high-fiber, low protein diet or the low-fiber, high-protein diet.
| Arm | Type | Receives |
|---|---|---|
| High-fiber, low-protein diet | Other | Other: High-fiber, low-protein dietParticipants will consume a high-fiber, low-protein diet for at least 4 weeks. All meals will be provided free of charge. No substitutions will be permitted. |
| Low-fiber, high-protein diet | Other | Other: Low-fiber, high-protein dietParticipants will consume a low-fiber, high-protein diet for at least 4 weeks. All meals will be provided free of charge. No substitutions will be permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥ 18 years old
- On a baseline diet characterized by: Fiber intake of </= 20g/day, > 18% of daily calories from protein
Key exclusion criteria (17 listed)
- Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
- Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory GI condition
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
- Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
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-fiber, low-protein dietDiet will consist of at least 15g fiber above baseline and less than 10% of calories from protein. | Other | High-fiber, low-protein diet |
| Low-fiber, high-protein dietDiet will consist of less than 15g fiber and greater than 18% of calories from protein | Other | Low-fiber, high-protein diet |
Primary outcome
Urinary Excretion of Lactulose and 13C-Mannitol
Time frame: 4 weeks
Small Bowel and Colonic Permeability by Urinary Excretion of Lactulose and 13C-Mannitol after Oral Ingestion of lactulose and 13C mannitol (5:1 ratio by mass). The 0-2h urine most closely reflects small intestinal permeability and 8-24h urine reflects colonic permeability. HPLC-tandem mass spectrometry will be used for detection of the sugars. The results will be expressed as the ratio of percentage excretion of the ingested dose of lactulose and mannitol in urine.
1 secondary outcome
Change in gut microbial alpha diversity based on Shannon index
Time frame: 4 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 15 May 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Purna C. Kashyap, MBBS principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fiber, low-protein diet and Low-fiber, high-protein diet in people with Healthy, run by Mayo Clinic at 2 sites 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 2 inclusion and 17 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 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Urinary Excretion of Lactulose and 13C-Mannitol (time frame: 4 weeks). 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 15 May 2023.