HealthyMCTsNCT03610477
MiCrobiome dieT Study
A study testing Medium chain triglycerides and Long chain triglycerides in people with Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
The human gut microbiome is the community of bacteria that reside within the human intestine. These microbes are constantly exposed to the end-products and partial break-down-products of digestion from the foods consumed each day. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Medium chain triglycerides and Long chain triglycerides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Dec 2017
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult over 18 years
Who cannot join
- Type 1 diabetes mellitus or insulin dependent type II diabetes mellitus
- Individuals currently maintaining a ketogenic diet
- Women who are currently pregnant or breast feeding
- Use of antibiotics in the last 3 months
- Self-reported pre-existing history of liver disease e.g. cirrhosis or diagnosed fatty liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Normal Dietary Intake and Medium Chain Triglycerides Supplementation on the Human Microbiome
The human gut microbiome is the community of bacteria that reside within the human intestine. These microbes are constantly exposed to the end-products and partial break-down-products of digestion from the foods consumed each day. Very little is known about the complex interaction of specific dietary components with the microbiome over time in one individual. In order to produce robust analysis of these interactions, longitudinal samples with detailed dietary intake information from healthy human subjects are needed.
The complex relationship between dietary intake and the microbiome, and the potential health implications of human exposure to microbial metabolites, are only beginning to be understood. It is well known that altered dietary intake can trigger rapid, although transient, changes in the composition of the microbiome in as little as 1 to 2 days. The biggest factors in determining microbial response to diet are thought to include an individual's starting microbiome, long-term dietary habits, and environmental exposures.
Read more
It is not well understood how small dietary differences from day-to-day impact the microbiome. A longitudinal dataset with accurately recorded dietary data and multiple samples over 17 days will provide valuable insight into the changes that occur at the individual level over time, while controlling for dietary trends and initial microbiome composition.
Medium chain triglycerides (MCTs) have systemic beneficial effects and increase survival in rats by preventing gut injury and permeability following lipopolysaccharide administration, preventing alcohol-induced liver injury, and protecting against the development of colitis in a model of Crohn's disease. Understanding the interaction of MCTs with the microbiome in humans could lead to important advancements in the understanding of how diet impacts the microbiome composition, and ultimately, human health. This proposed study is designed to evaluate the effect of MCTs compared with long chain triglycerides on the normal structure of the microbiome and data will not be used to diagnose, prevent, cure or treat disease.
The purpose of this study is to: 1) investigate the role daily dietary variation plays in microbiome composition and stability, and 2) explore the effect of MCT supplementation on microbiome composition in healthy adults.
- Conditions
- Healthy
- Being tested
- Medium chain triglycerides, Long chain triglycerides
- Keywords
- Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium chain triglyceridesDietary supplement
Gel capsules, each containing 1 gram
Long chain triglyceridesDietary supplement
Gel capsules, each containing 1 gram
| Study group | Role | What they receive |
|---|---|---|
| Medium Chain Triglyceride | Active comparator | Participants will be randomized to consume 5% of total energy intake from medium chain triglycerides. Receives: Dietary Supplement: Medium chain triglycerides |
| Long Chain Triglyceride | Placebo comparator | Participants will be randomized to consume 5% of total energy intake from long chain triglycerides. Receives: Dietary Supplement: Long chain triglycerides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome composition
Species-level compositional assessment
Measured: Change from baseline daily for 17 days
Dietary intake variation
Collected as 24-hour daily recalls assessed using novel methods for dietary pattern assessment
Measured: Change from baseline daily for 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610477
- Sponsor's protocol ID
- 1610M95982
- Acronym
- MCTs
- Status last verified
- Oct 2019
- First submitted
- 20 Jul 2018
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johnson AJ, Vangay P, Al-Ghalith GA, Hillmann BM, Ward TL, Shields-Cutler RR, Kim AD, Shmagel AK, Syed AN; Personalized Microbiome Class Students; Walter J, Menon R, Koecher K, Knights D. Daily Sampling Reveals Personalized Diet-Microbiome Associations in Humans. Cell Host Microbe. 2019 Jun 12;25(6):789-802.e5. doi: 10.1016/j.chom.2019.05.005.
PubMed 31194939
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normal Dietary Intake and Medium Chain Triglycerides Supplementation on the Human Microbiome
- ClinicalTrials.gov ID
- NCT03610477
- Acronym / sponsor ID
- MCTs / 1610M95982
- Conditions
- Healthy
- Keywords
- Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 1 Aug 2018 (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 human gut microbiome is the community of bacteria that reside within the human intestine. These microbes are constantly exposed to the end-products and partial break-down-products of digestion from the foods consumed each day. Very little is known about the complex interaction of specific dietary components with the microbiome over time in one individual. In order to produce robust analysis of these interactions, longitudinal samples with detailed dietary intake information from healthy human subjects are needed.
The complex relationship between dietary intake and the microbiome, and the potential health implications of human exposure to microbial metabolites, are only beginning to be understood. It is well known that altered dietary intake can trigger rapid, although transient, changes in the composition of the microbiome in as little as 1 to 2 days. The biggest factors in determining microbial response to diet are thought to include an individual's starting microbiome, long-term dietary habits, and environmental exposures.
It is not well understood how small dietary differences from day-to-day impact the microbiome. A longitudinal dataset with accurately recorded dietary data and multiple samples over 17 days will provide valuable insight into the changes that occur at the individual level over time, while controlling for dietary trends and initial microbiome composition.
Medium chain triglycerides (MCTs) have systemic beneficial effects and increase survival in rats by preventing gut injury and permeability following lipopolysaccharide administration, preventing alcohol-induced liver injury, and protecting against the development of colitis in a model of Crohn's disease. Understanding the interaction of MCTs with the microbiome in humans could lead to important advancements in the understanding of how diet impacts the microbiome composition, and ultimately, human health. This proposed study is designed to evaluate the effect of MCTs compared with long chain triglycerides on the normal structure of the microbiome and data will not be used to diagnose, prevent, cure or treat disease.
The purpose of this study is to: 1) investigate the role daily dietary variation plays in microbiome composition and stability, and 2) explore the effect of MCT supplementation on microbiome composition in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium Chain Triglyceride | Active comparator | Dietary Supplement: Medium chain triglyceridesParticipants will be randomized to consume 5% of total energy intake from medium chain triglycerides. |
| Long Chain Triglyceride | Placebo comparator | Dietary Supplement: Long chain triglyceridesParticipants will be randomized to consume 5% of total energy intake from long chain triglycerides. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult over 18 years
Key exclusion criteria (5 listed)
- Type 1 diabetes mellitus or insulin dependent type II diabetes mellitus
- Individuals currently maintaining a ketogenic diet
- Women who are currently pregnant or breast feeding
- Use of antibiotics in the last 3 months
- Self-reported pre-existing history of liver disease e.g. cirrhosis or diagnosed fatty liver disease.
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 |
|---|---|---|
| Medium chain triglyceridesGel capsules, each containing 1 gram | Dietary supplement | Medium Chain Triglyceride |
| Long chain triglyceridesGel capsules, each containing 1 gram | Dietary supplement | Long Chain Triglyceride |
Primary outcome
Microbiome composition
Time frame: Change from baseline daily for 17 days
Species-level compositional assessment
Dietary intake variation
Time frame: Change from baseline daily for 17 days
Collected as 24-hour daily recalls assessed using novel methods for dietary pattern assessment
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 1 Nov 2019.
- Derived from this study: PubMed 31194939Johnson AJ, Vangay P, Al-Ghalith GA, Hillmann BM, Ward TL, Shields-Cutler RR, Kim AD, Shmagel AK, Syed AN; Personalized Microbiome Class Students; Walter J, Menon R, Koecher K, Knights D. Daily Sampling Reveals Personalized Diet-Microbiome Associations in Humans. Cell Host Microbe. 2019 Jun 12;25(6):789-802.e5. doi: 10.1016/j.chom.2019.05.005.
Related trials for Healthy
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium chain triglycerides and Long chain triglycerides in people with Healthy, 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 1 inclusion and 5 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 1 Nov 2019. 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.
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?
Microbiome composition (time frame: Change from baseline daily for 17 days). 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?
On the ClinicalTrials.gov record for NCT03610477, which also lists 1 linked publication.
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 1 Nov 2019; AzTrials last refreshed its copy on 31 Oct 2026.