Diabetes Mellitus, Type 2PYHNCT03315988
The Effects of an 8-week Vegan Diet on TMAO Levels and Post-challenge Glucose Levels in Individuals With Dysglycaemia
A study testing Adoption of a vegan diet in people with Diabetes Mellitus, Type 2 and Heart Diseases, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The amount of people with diabetes mellitus has now reached over 4 million in the United Kingdom. Type 2 diabetes accounts for the majority of all cases of diabetes and increases the risk of many other diseases such as heart problems. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Heart Diseases
- What is being tested?
- Adoption of a vegan diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2017to 7 Jan 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- And either:
- Overweight (White: BMI>25 - <30, South Asian/ Black and minority ethnic group <27.5) with HbA1c between HbA1c ≥5.7% and ≤ 8% (39-64 mmol/mol) identified within the last 36 months
- Obese: (White: BMI ≥30, South Asian/ Black and minority ethnic group: ≥27.5)
- Male or Female
- Aged 18 - 75 years inclusive
Show all 9Show fewer
- Able to understand, read and speak the English language to a sufficient level to understand and take part to the study in the investigators opinion
- Have access to a phone, and willing to use it as part of the study
- Regular meat and/or fish eater (at least 3 times per week)-self reported
Who cannot join
- Participant is unwilling or unable to give informed consent
- Non-English speakers
- HbA1c above 8% (64 mmol/mol)
- Taking any form of glucose lowering medication currently or within the last 60 days
- Current smokers
- Current use of vegan or vegetarian diet
Show all 13Show fewer
- Recent significant weight change (10% or more) over the last 3 months
- Pregnancy/lactation
- Clinical eating disorder as detected by their GP or relevant health professional (e.g. dietitian)
- Have a terminal illness
- Current or recent (within 6 months) oral antibiotics or steroid use as their usage could impact on the gut bacteria profile
- Ongoing CVD (e.g. angina) *
- In the circumstance that an individual is not sure whether they meet the inclusion/ exclusion criteria, (i.e. they are not sure if they have ongoing CVD) this will be reviewed by a named medic on the delegation of authority log for a clinical decision to be made during baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an 8-week Vegan Diet on Trimethylamine-N-Oxide (TMAO) Levels and Post-challenge Glucose Levels in Individuals With Dysglycaemia (The Plant Your Health Study)
The amount of people with diabetes mellitus has now reached over 4 million in the United Kingdom. Type 2 diabetes accounts for the majority of all cases of diabetes and increases the risk of many other diseases such as heart problems. Plant based diets are thought to be an effective way to improve markers of health related to type 2 diabetes and heart disease. One way that a plant based diet improves health could be through reducing waste products that are generated in the gut by the bacteria that break down food as part of the digestion process. For example, the digestion of some meats, fish and eggs results in the creation of a substance called Trimethylamine-N-Oxide (TMAO) which has been linked to worse health outcomes in several studies. However, the full impact on TMAO and blood glucose levels of swapping regular meat consumption for a plant based vegan diet is not fully understood and requires further research. Therefore, the aim of this study will be to develop and undertake a clinical trial to investigate the effects of an 8-week vegan diet on TMAO levels and post challenge glucose levels in individuals with dysglycaemia (drug naïve).
The study will be interventional single group prospective trial of adults aged 18-75 years of age from a multi-ethnic population with dysglycaemia (drug naïve). A sample of 29 people will be sought. The dietary intervention (vegan diet) will last 8 weeks. Then, the participants will go back to their normal diet and come for their final visit after a four week follow-up period (week 12). To assess the effectiveness of the intervention, primary and secondary outcome data collected at baseline will be compared with data collected at 1 week, 8 weeks and 12 weeks.
Read the detailed description
Study Design
Interventional single group prospective trial in a patient population with identified dysglycaemia within the past 36 months defined as 2h post-challenge glucose ≥7.8 mmol/L after a standard oral glucose tolerance test or HbA1c ≥5.7% (39-46 mmol/mol). This phase clinical trial will evaluate the efficacy and underlining mechanisms of a vegan diet in promoting cardiometabolic health in those with dysglycaemia. Specifically, this trial will aim to investigate the effect of an 8-week vegan diet with follow-up at 1, 8 and 12 weeks.
Study Setting
The study will be co-ordinated within the Leicester Biomedical Research Centre (Leicester Diabetes Centre) at the Leicester General Hospital. Clinical measurement sessions will be carried out by the appointed research team. Participants will be asked to visit the study centre on five occasions.
Intervention Description and Definition
The participants will be asked to follow a diet that excludes foods hypothesised to support the syntheses of TMAO, particularly meat (any), eggs and fish (any). A number of studies suggest that dairy products may also have an effect in modulating TMAO production whereas other studies do not. Therefore, in order to avoid any potential contaminating or confounding effect, dairy products will also be avoided.
The diet employed in this study is broadly aligned to a vegan diet. The term vegan will be used to aid behaviour change and food choice. For example, an increasing array of products are now pack marked as vegan. The participants will be asked to keep their diet similar to their original and the Registered Dietitian involved in this study will plan their weekly menus accordingly.
- Conditions
- Diabetes Mellitus, Type 2, Heart Diseases
- Being tested
- Adoption of a vegan diet
- Keywords
- type 2 diabetes, vegan diet, TMAO, cardiovascular disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adoption of a vegan dietOther
Adoption of a vegan diet The participants of this study wil be asked to adopt a vegan diet under the supervision of a Registered Dietitian.
| Study group | Role | What they receive |
|---|---|---|
| Vegan diet | Experimental | Intervention Description and Definition The participants will be asked to follow a diet that excludes foods hypothesised to support the syntheses of TMAO, particularly meat (any), eggs and fish (any). A number of studies suggest that dairy products may also have an effect in modulating TMAO production whereas other studies do not. Therefore, in order to avoid any potential contaminating or confounding effect, dairy products will also be avoided.
The diet employed in this study is broadly aligned to a vegan diet. The term vegan will be used to aid behaviour change and food choice. For example, an increasing array of products are now pack marked as vegan. The participants will be asked to keep their diet similar to their original and the Registered Dietitian involved in this study will plan their weekly menus accordingly. Receives: Other: Adoption of a vegan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline TMAO plasma levels at 1, 8 and 12 weeks.
urine and plasma samples for TMAO (μM)
Measured: at 1 (+ 5 days) week , 8 (+/- 5 days) weeks and 12 weeks (+/- 5 days)
Change from Baseline 3-hour post-challenge glucose levels at 1, 8 and 12 weeks.
blood samples (mmol/l)
Measured: at 1 (+ 5 days) week , 8 (+/- 5 days) weeks and 12 weeks (+/- 5 days)
Secondary outcomes (24)
TMAO (μM) urine levels at baseline.
urine samples
Measured: at baseline
Change from Baseline in TMAO urine/plasma levels at 1 week following a vegan diet.
urine and plasma samples; TMAO (μM)
Measured: at 1 week (+ 5 days)
Change from Baseline 3-hour post-challenge glucose levels at 1 week following a vegan diet.
blood samples for glucose (mmol/l)
Measured: at 1 week (+ 5 days)
Change from week 8 in TMAO urine/plasma levels at 4 weeks after diet has returned to normal (week 12).
urine and plasma samples for TMAO (μM)
Measured: at 12 weeks (+/- 5 days)
Change from week 8 in 3-hour post-challenge glucose levels at 4 weeks after diet has returned to normal (week 12).
blood samples for glucose (mmol/l)
Measured: at 12 weeks (+/- 5 days)
Change from Baseline in body composition using dual energy X-ray absorptiometry (DXA) scan at 8 weeks following a vegan diet.
DXA Scan
Measured: at baseline and week 8 (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including post-challenge insulin at 1 week.
blood samples (mmol/l)
Measured: 1 week (+5 days)
Change from Baseline in biochemical measures of cardiometabolic health including post-challenge insulin at 8 weeks.
blood samples (mmol/l)
Measured: 8 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including post-challenge insulin at 12 weeks.
blood samples (mmol/l)
Measured: 12 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including fasting lipids and at 1 week.
blood samples (mmol/l)
Measured: 1 week (+5 days)
Change from Baseline in biochemical measures of cardiometabolic health including fasting lipids and inflammatory markers at 8 weeks.
blood samples (mmol/l)
Measured: 8 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including fasting lipids at 12 weeks.
blood samples (mmol/l)
Measured: 12 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including inflammatory markers at 1 week.
blood samples (mmol/l)
Measured: 1 week (+5 days)
Change from Baseline in biochemical measures of cardiometabolic health including inflammatory markers at 8 weeks.
blood samples (mmol/l)
Measured: 8 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including inflammatory markers at 12 weeks.
blood samples (mmol/l)
Measured: 12 weeks (+/- 5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to body composition.
DXA scan
Measured: baseline
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to body composition.
DXA scan
Measured: week 8 (+/- 5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
3-day diet diaries
Measured: baseline
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
3-day diet diaries
Measured: counselling visit (+5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
3-day diet diaries
Measured: week 1 (+5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
3-day diet diaries
Measured: week 8 (+/- 5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
3-day diet diaries
Measured: week 12 (+/- 5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
accelerometers
Measured: weeks 1-12
Semi-structured interviews with the completers, at the end of the study, to investigate perception responses having been on a vegan diet.
semi-structured interviews
Measured: at week 12 (+/- 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start4 Oct 2017
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
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 Diabetes Mellitus, Type 2Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315988
- Sponsor's protocol ID
- 0625
- Acronym
- PYH
- Status last verified
- Sep 2018
- First submitted
- 4 Oct 2017
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Argyridou S, Davies MJ, Biddle GJH, Bernieh D, Suzuki T, Dawkins NP, Rowlands AV, Khunti K, Smith AC, Yates T. Evaluation of an 8-Week Vegan Diet on Plasma Trimethylamine-N-Oxide and Postchallenge Glucose in Adults with Dysglycemia or Obesity. J Nutr. 2021 Jul 1;151(7):1844-1853. doi: 10.1093/jn/nxab046.
PubMed 33784394
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an 8-week Vegan Diet on Trimethylamine-N-Oxide (TMAO) Levels and Post-challenge Glucose Levels in Individuals With Dysglycaemia (The Plant Your Health Study)
- ClinicalTrials.gov ID
- NCT03315988
- Acronym / sponsor ID
- PYH / 0625
- Conditions
- Diabetes Mellitus, Type 2, Heart Diseases
- Keywords
- type 2 diabetes, vegan diet, TMAO, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 20 Oct 2017 (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 amount of people with diabetes mellitus has now reached over 4 million in the United Kingdom. Type 2 diabetes accounts for the majority of all cases of diabetes and increases the risk of many other diseases such as heart problems. Plant based diets are thought to be an effective way to improve markers of health related to type 2 diabetes and heart disease. One way that a plant based diet improves health could be through reducing waste products that are generated in the gut by the bacteria that break down food as part of the digestion process. For example, the digestion of some meats, fish and eggs results in the creation of a substance called Trimethylamine-N-Oxide (TMAO) which has been linked to worse health outcomes in several studies. However, the full impact on TMAO and blood glucose levels of swapping regular meat consumption for a plant based vegan diet is not fully understood and requires further research. Therefore, the aim of this study will be to develop and undertake a clinical trial to investigate the effects of an 8-week vegan diet on TMAO levels and post challenge glucose levels in individuals with dysglycaemia (drug naïve).
The study will be interventional single group prospective trial of adults aged 18-75 years of age from a multi-ethnic population with dysglycaemia (drug naïve). A sample of 29 people will be sought. The dietary intervention (vegan diet) will last 8 weeks. Then, the participants will go back to their normal diet and come for their final visit after a four week follow-up period (week 12). To assess the effectiveness of the intervention, primary and secondary outcome data collected at baseline will be compared with data collected at 1 week, 8 weeks and 12 weeks.
Detailed description
Study Design
Interventional single group prospective trial in a patient population with identified dysglycaemia within the past 36 months defined as 2h post-challenge glucose ≥7.8 mmol/L after a standard oral glucose tolerance test or HbA1c ≥5.7% (39-46 mmol/mol). This phase clinical trial will evaluate the efficacy and underlining mechanisms of a vegan diet in promoting cardiometabolic health in those with dysglycaemia. Specifically, this trial will aim to investigate the effect of an 8-week vegan diet with follow-up at 1, 8 and 12 weeks.
Study Setting
The study will be co-ordinated within the Leicester Biomedical Research Centre (Leicester Diabetes Centre) at the Leicester General Hospital. Clinical measurement sessions will be carried out by the appointed research team. Participants will be asked to visit the study centre on five occasions.
Intervention Description and Definition
The participants will be asked to follow a diet that excludes foods hypothesised to support the syntheses of TMAO, particularly meat (any), eggs and fish (any). A number of studies suggest that dairy products may also have an effect in modulating TMAO production whereas other studies do not. Therefore, in order to avoid any potential contaminating or confounding effect, dairy products will also be avoided.
The diet employed in this study is broadly aligned to a vegan diet. The term vegan will be used to aid behaviour change and food choice. For example, an increasing array of products are now pack marked as vegan. The participants will be asked to keep their diet similar to their original and the Registered Dietitian involved in this study will plan their weekly menus accordingly.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vegan diet | Experimental | Other: Adoption of a vegan dietIntervention Description and Definition The participants will be asked to follow a diet that excludes foods hypothesised to support the syntheses of TMAO, particularly meat (any), eggs and fish (any). A number of studies suggest that dairy products may also have an effect in modulating TMAO production whereas other studies do not. Therefore, in order to avoid any potential contaminating or confounding effect, dairy products will also be avoided. The diet employed in this study is broadly aligned to a vegan diet. The term vegan will be used to aid behaviour change and food choice. For example, an increasing array of products are now pack marked as vegan. The participants will be asked to keep their diet similar to their original and the Registered Dietitian involved in this study will plan their weekly menus accordingly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant is willing and able to give informed consent for participation in the study
- And either:
- Male or Female
- Aged 18 - 75 years inclusive
- Able to understand, read and speak the English language to a sufficient level to understand and take part to the study in the investigators opinion
Key exclusion criteria (13 listed)
- Participant is unwilling or unable to give informed consent
- Non-English speakers
- HbA1c above 8% (64 mmol/mol)
- Taking any form of glucose lowering medication currently or within the last 60 days
- 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 |
|---|---|---|
| Adoption of a vegan dietAdoption of a vegan diet The participants of this study wil be asked to adopt a vegan diet under the supervision of a Registered Dietitian. | Other | Vegan diet |
Primary outcome
Change from Baseline TMAO plasma levels at 1, 8 and 12 weeks.
Time frame: at 1 (+ 5 days) week , 8 (+/- 5 days) weeks and 12 weeks (+/- 5 days)
urine and plasma samples for TMAO (μM)
Change from Baseline 3-hour post-challenge glucose levels at 1, 8 and 12 weeks.
Time frame: at 1 (+ 5 days) week , 8 (+/- 5 days) weeks and 12 weeks (+/- 5 days)
blood samples (mmol/l)
24 secondary outcomes
TMAO (μM) urine levels at baseline.
Time frame: at baseline
Change from Baseline in TMAO urine/plasma levels at 1 week following a vegan diet.
Time frame: at 1 week (+ 5 days)
Change from Baseline 3-hour post-challenge glucose levels at 1 week following a vegan diet.
Time frame: at 1 week (+ 5 days)
Change from week 8 in TMAO urine/plasma levels at 4 weeks after diet has returned to normal (week 12).
Time frame: at 12 weeks (+/- 5 days)
Change from week 8 in 3-hour post-challenge glucose levels at 4 weeks after diet has returned to normal (week 12).
Time frame: at 12 weeks (+/- 5 days)
Change from Baseline in body composition using dual energy X-ray absorptiometry (DXA) scan at 8 weeks following a vegan diet.
Time frame: at baseline and week 8 (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including post-challenge insulin at 1 week.
Time frame: 1 week (+5 days)
Change from Baseline in biochemical measures of cardiometabolic health including post-challenge insulin at 8 weeks.
Time frame: 8 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including post-challenge insulin at 12 weeks.
Time frame: 12 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including fasting lipids and at 1 week.
Time frame: 1 week (+5 days)
Change from Baseline in biochemical measures of cardiometabolic health including fasting lipids and inflammatory markers at 8 weeks.
Time frame: 8 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including fasting lipids at 12 weeks.
Time frame: 12 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including inflammatory markers at 1 week.
Time frame: 1 week (+5 days)
Change from Baseline in biochemical measures of cardiometabolic health including inflammatory markers at 8 weeks.
Time frame: 8 weeks (+/- 5 days)
Change from Baseline in biochemical measures of cardiometabolic health including inflammatory markers at 12 weeks.
Time frame: 12 weeks (+/- 5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to body composition.
Time frame: baseline
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to body composition.
Time frame: week 8 (+/- 5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
Time frame: baseline
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
Time frame: counselling visit (+5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
Time frame: week 1 (+5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
Time frame: week 8 (+/- 5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
Time frame: week 12 (+/- 5 days)
The extent to which changes in the primary outcomes are mediated by, or independent of, changes to lifestyle factors.
Time frame: weeks 1-12
Semi-structured interviews with the completers, at the end of the study, to investigate perception responses having been on a vegan diet.
Time frame: at week 12 (+/- 5 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 30 Jan 2020.
- Derived from this study: PubMed 33784394Argyridou S, Davies MJ, Biddle GJH, Bernieh D, Suzuki T, Dawkins NP, Rowlands AV, Khunti K, Smith AC, Yates T. Evaluation of an 8-Week Vegan Diet on Plasma Trimethylamine-N-Oxide and Postchallenge Glucose in Adults with Dysglycemia or Obesity. J Nutr. 2021 Jul 1;151(7):1844-1853. doi: 10.1093/jn/nxab046.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 Adoption of a vegan diet in people with Diabetes Mellitus, Type 2 and Heart Diseases, run by University of Leicester 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 9 inclusion and 13 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 30 Jan 2020. 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?
Change from Baseline TMAO plasma levels at 1, 8 and 12 weeks. (time frame: at 1 (+ 5 days) week , 8 (+/- 5 days) weeks and 12 weeks (+/- 5 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 NCT03315988, 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 30 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.