Healthy NutritionNCT05333900
Dietary Impact on Intestinal Sulfate Metabolism
A study testing Plant-Based Diet then animal-based diet and Animal-based diet then plant-based diet in people with Healthy Nutrition, run by University of Minnesota at 1 site in United States.
Trial summary
This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing amino acids (High-S diet), emphasizing… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- Plant-Based Diet then animal-based diet and Animal-based diet then plant-based diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2016to 18 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide informed consent
- Ambulatory and community dwelling
- Able and willing to comply with the study schedule and procedures
- 18 - 80 years of age
- BMI between 18.5 - 40.0 kg/m2
- Omnivorous or willing to consume animal products through duration of study
Who cannot join
- Antibiotic use within 3 months
- Planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics.
- Use of sulfonamides or sulfasalazine, as these sulfur-containing medications may confound results
- Use of 5-aminosalicylates (5-ASA), as they are known to inhibit sulfidogenesis
- History of anaphylactic food allergies, e.g., peanuts, seafood.
- Food intolerances and allergies, including gluten sensitivity, lactose intolerance, and intolerance of high fiber dietary content.
Show all 15Show fewer
- Strict vegan eating practices, with refusal to consume animal products.
- Planned use of oral probiotics while on study.
- Serious, concomitant illness that, in the opinion of the Investigator, would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation.
- Significant alcohol use, defined as > 20 g/day in females and > 30 g/day in males for a period of 3 months within one year prior to screening.
- Underlying chronic gastrointestinal disease that can cause diarrhea, including short bowel syndrome, irritable bowel syndrome, malabsorption, and celiac disease.
- History of partial or complete colectomy.
- History of malabsorptive bariatric surgery.
- Currently participating in another clinical study.
- Legally incompetent and unable to understand the study's purpose, significance and consequences, and to make decisions accordingly.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources. A 14-day washout period will follow each intervention, in which participants will eat their typical diets.
- Conditions
- Healthy Nutrition
- Being tested
- Plant-Based Diet then animal-based diet, Animal-based diet then plant-based diet
- Keywords
- Animal-based, Plant-based, Microbiome, Hydrogen sulfide, Ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-Based Diet then animal-based dietBehavioural
Participants started with plant based diet: high in fiber, low in animal products for 7 days, with 14 day washout period between interventions. Following that, participants were switched to animal-based diet: high in animal products, low in fiber for 7 days.
Animal-based diet then plant-based dietBehavioural
Participants were started with animal-based diet: high in animal products, low in fiber for 7 days, with 14 days washout period between interventions. Following that, participants were switched to plant-based diet: high in fiber, low in animal products for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Plant-based then animal based | Active comparator | plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources Receives: Behavioral: Plant-Based Diet then animal-based diet |
| Animal-based then plant based | Active comparator | plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources Receives: Behavioral: Animal-based diet then plant-based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production
Determine the effect of short-term (1-week) plant- and animal-based eating patterns on ex vivo fecal hydrogen sulfide production in healthy human volunteers We will measure fecal hydrogen sulfide production ex vivo in ppm/g of dry weight of stool
Measured: Following 1-week of plant- and animal-based eating patterns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start7 Dec 2016
- Primary completion31 Dec 2020
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- 5-week crossover pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Khoruts, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333900
- Sponsor's protocol ID
- GI-2016-25182
- Status last verified
- Dec 2023
- First submitted
- 4 Mar 2022
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Impact on Intestinal Sulfate Metabolism
- ClinicalTrials.gov ID
- NCT05333900
- Acronym / sponsor ID
- GI-2016-25182
- Conditions
- Healthy Nutrition
- Keywords
- Animal-based, Plant-based, Microbiome, Hydrogen sulfide, Ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources. A 14-day washout period will follow each intervention, in which participants will eat their typical diets.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 5-week crossover pilot study
| Arm | Type | Receives |
|---|---|---|
| Plant-based then animal based | Active comparator | Behavioral: Plant-Based Diet then animal-based dietplant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources |
| Animal-based then plant based | Active comparator | Behavioral: Animal-based diet then plant-based dietplant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide informed consent
- Ambulatory and community dwelling
- Able and willing to comply with the study schedule and procedures
- 18 - 80 years of age
- BMI between 18.5 - 40.0 kg/m2
Key exclusion criteria (15 listed)
- Antibiotic use within 3 months
- Planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics.
- Use of sulfonamides or sulfasalazine, as these sulfur-containing medications may confound results
- Use of 5-aminosalicylates (5-ASA), as they are known to inhibit sulfidogenesis
- History of anaphylactic food allergies, e.g., peanuts, seafood.
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 |
|---|---|---|
| Plant-Based Diet then animal-based dietParticipants started with plant based diet: high in fiber, low in animal products for 7 days, with 14 day washout period between interventions. Following that, participants were switched to animal-based diet: high in animal products, low in fiber for 7 days. | Behavioural | Plant-based then animal based |
| Animal-based diet then plant-based dietParticipants were started with animal-based diet: high in animal products, low in fiber for 7 days, with 14 days washout period between interventions. Following that, participants were switched to plant-based diet: high in fiber, low in animal products for 7 days | Behavioural | Animal-based then plant based |
Primary outcome
Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production
Time frame: Following 1-week of plant- and animal-based eating patterns
Determine the effect of short-term (1-week) plant- and animal-based eating patterns on ex vivo fecal hydrogen sulfide production in healthy human volunteers We will measure fecal hydrogen sulfide production ex vivo in ppm/g of dry weight of stool
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alexander Khoruts principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-Based Diet then animal-based diet and Animal-based diet then plant-based diet in people with Healthy Nutrition, run by University of Minnesota 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 6 inclusion and 15 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 5 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production (time frame: Following 1-week of plant- and animal-based eating patterns). 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 5 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.