MicrobiotaSUSUGUTNCT05231317
Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study
A study testing Plant-based diet and Western diet in people with Microbiota and Nutrition, Healthy, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Unhealthy diets are closely linked to non-communicable diseases and constitute higher risk of morbidity and mortality than unsafe sex, alcohol, tobacco and drugs use combined. According to the World Health Organization (WHO), a healthy diet follows a plant-based pattern with low quantities of red meat and a low simple… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Nutrition, Healthy
- What is being tested?
- Plant-based diet and Western diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2021to 17 Dec 2021
- 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
- Free-living, apparently healthy adults
- Bmi>18
- Aged 18-70 years at recruitment
- Non-smokers
Who cannot join
- Non-free-living adults
- Adults <18 or >70 years at recruitment
- BMI<18
- Current smokers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Londonderry, BT52 1SA
About this study
Unhealthy diets are closely linked to non-communicable diseases and constitute higher risk of morbidity and mortality than unsafe sex, alcohol, tobacco and drugs use combined. According to the World Health Organization (WHO), a healthy diet follows a plant-based pattern with low quantities of red meat and a low simple sugar intake. It would also reduce anthropological ecologic impact. We hypothesize that a plant-based diet will beneficially modify the gut microbiota and metabolome, influencing also Trimethylamine N-oxide (TMAO), a metabolite associated to CVD.
This study has a randomized single blind crossover design that compares a plant-based diet towards a control western diet. It is applied to volunteers aged 18-70 years, N=20. Each dietary intervention (plant-based and western) would last for 16 consecutive days separated by a minimum of 7 weeks washout period (intervention 1-washout-intervention 2). Samples of blood urine and faeces will be collected at day 1 and 14 of each intervention. On day 14 will be performed L-carnitine challenge with 1200mg of L-carnitine to test the levels of TMAO), in for the next 2 consecutive days (24h and 48h post treatment).
- Conditions
- Microbiota, Nutrition, Healthy
- Being tested
- Plant-based diet, Western diet
- Keywords
- Plant-based diet, Western diet, Gut microbiota,, Trimethylamine N-oxide, Human intervention study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietOther
16 days with all foods provided
Western dietOther
16 days with all foods provided
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Plant-based diet | Experimental | Diet rich in fruit and vegetables (42% carbohydrates, 17.2% fibres; 15% proteins and 43% fats). Receives: Other: Plant-based diet |
| Active Comparator: Western diet | Active comparator | Diet Rich in Processed Foods (48% carbohydrates, 10.4% fibres; 14% proteins and 39% fats). Receives: Other: Western diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota changes
Significant changes in the number of bifidobacteria
Measured: Change over 14 days
Quantification of Trimethylamine N-oxide
Changes in response to L-Carnitine challenge
Measured: Day 16
Secondary outcomes (5)
Bioactivity of faecal water
Measured by using faecal water as basis for growth media (ex vivo measure)
Measured: Change over 14 days
Effects on inflammatory markers of both diets
Cytokine analysis via ELISA test (MagPix)
Measured: Change over 14 days
Ex vivo effects of faecal water on gut pathobionts
Co-culturing the aqueous phase of faeces with C. difficile to assess changes in its biology
Measured: Day 14
Quantification of phytochemicals
Measured by LC-MS
Measured: Change over 14 days
Quantification of Short Chain Fatty Acids (SCFA)
Measured by nuclear magnetic resonance (NMR)
Measured: Change over 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start2 Jul 2021
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over single-blinded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Edmund Mach
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231317
- Sponsor's protocol ID
- REC/20/0008
- Acronym
- SUSUGUT
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- 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 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study
- ClinicalTrials.gov ID
- NCT05231317
- Acronym / sponsor ID
- SUSUGUT / REC/20/0008
- Conditions
- Microbiota, Nutrition, Healthy
- Keywords
- Plant-based diet, Western diet, Gut microbiota,, Trimethylamine N-oxide, Human intervention study.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Fondazione Edmund Mach
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 9 Feb 2022 (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.
Unhealthy diets are closely linked to non-communicable diseases and constitute higher risk of morbidity and mortality than unsafe sex, alcohol, tobacco and drugs use combined. According to the World Health Organization (WHO), a healthy diet follows a plant-based pattern with low quantities of red meat and a low simple sugar intake. It would also reduce anthropological ecologic impact. We hypothesize that a plant-based diet will beneficially modify the gut microbiota and metabolome, influencing also Trimethylamine N-oxide (TMAO), a metabolite associated to CVD.
This study has a randomized single blind crossover design that compares a plant-based diet towards a control western diet. It is applied to volunteers aged 18-70 years, N=20. Each dietary intervention (plant-based and western) would last for 16 consecutive days separated by a minimum of 7 weeks washout period (intervention 1-washout-intervention 2). Samples of blood urine and faeces will be collected at day 1 and 14 of each intervention. On day 14 will be performed L-carnitine challenge with 1200mg of L-carnitine to test the levels of TMAO), in for the next 2 consecutive days (24h and 48h post treatment).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cross-over single-blinded
| Arm | Type | Receives |
|---|---|---|
| Experimental: Plant-based diet | Experimental | Other: Plant-based dietDiet rich in fruit and vegetables (42% carbohydrates, 17.2% fibres; 15% proteins and 43% fats). |
| Active Comparator: Western diet | Active comparator | Other: Western dietDiet Rich in Processed Foods (48% carbohydrates, 10.4% fibres; 14% proteins and 39% fats). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Free-living, apparently healthy adults
- Bmi>18
- Aged 18-70 years at recruitment
- Non-smokers
Key exclusion criteria (4 listed)
- Non-free-living adults
- Adults <18 or >70 years at recruitment
- BMI<18
- Current smokers
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 diet16 days with all foods provided | Other | Experimental: Plant-based diet |
| Western diet16 days with all foods provided | Other | Active Comparator: Western diet |
Primary outcome
Gut microbiota changes
Time frame: Change over 14 days
Significant changes in the number of bifidobacteria
Quantification of Trimethylamine N-oxide
Time frame: Day 16
Changes in response to L-Carnitine challenge
5 secondary outcomes
Bioactivity of faecal water
Time frame: Change over 14 days
Effects on inflammatory markers of both diets
Time frame: Change over 14 days
Ex vivo effects of faecal water on gut pathobionts
Time frame: Day 14
Quantification of phytochemicals
Time frame: Change over 14 days
Quantification of Short Chain Fatty Acids (SCFA)
Time frame: Change over 14 days
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 9 Feb 2022.
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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.
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 Plant-based diet and Western diet in people with Microbiota and Nutrition, Healthy, run by University of Ulster at 1 site in United Kingdom.
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 4 inclusion and 4 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 9 Feb 2022. 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 Kingdom. 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?
Gut microbiota changes (time frame: Change over 14 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?
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 9 Feb 2022.