Type 2 DiabetesEx nit asNCT02206074
The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise
A study testing Beetroot in people with Type 2 Diabetes, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The investigators are conducting a research study to see if increasing the amount of nitrate (a substance found in large quantities in certain vegetables) in the diet can increase the ability of individuals with Type 2 diabetes (T2D) to perform exercise. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Beetroot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Aug 2013
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with T2D (as defined by WHO) of at least 5 years duration between the ages of 35-75 will be invited.
Who cannot join
- patients with significant renal impairment (eGFR<30)
- uncontrolled hypertension
- BMI<25 or >35
- are taking regular organic nitrates, nicorandil, or thiazolidinidiones, or any medication which may interfere with data interpretation or safety
- who have had a myocardial infarction or cerebro-vascular event
- who smoke, or any other serious medical condition which would interfere with data interpretation or safety will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Peninsula NIHr Exeter Clinical Research Facility
Exeter, Devon, EX2 5DW
About this study
The investigators are conducting a research study to see if increasing the amount of nitrate (a substance found in large quantities in certain vegetables) in the diet can increase the ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D find exercise more uncomfortable than individuals who do not have T2D. This may be explained by the experimental studies showing that T2D can result in reductions in the supply of oxygen to the muscles. Studies have also shown that for a given level of activity, individuals with T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of dietary nitrate on the responses to exercise may have a significant impact on the ability of individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2) experimental studies suggest that increased nitrate consumption has been shown to reduce the amount of oxygen required for a given level of exercise.
The investigators will recruit 60 individuals with T2D. These people will take part in a randomised crossover design study where they will be asked to drink normal beetroot juice (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking). This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen required for a given level of exercise in individuals with T2D. To test brain function individuals will be asked to perform a standard computerised decision making task following consumption of the nitrate rich and nitrate depleted juices.
- Conditions
- Type 2 Diabetes
- Being tested
- Beetroot
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeetrootDietary supplement
Also called James Whites Drinks beetroot sports shot
| Study group | Role | What they receive |
|---|---|---|
| T2DM | Active comparator | Crossover design where participants will start in the Beetroot juice condition, and after a washout period, move into the other condition. Receives: Dietary Supplement: Beetroot |
| Placebo | Placebo comparator | Crossover design where participants will start in the placebo condition, and after a washout period, move into the other condition. Receives: Dietary Supplement: Beetroot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems
Pulmonary gas exchange was measured during treadmill walking exercise (MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems, St. Paul, MN, USA). Prior to each testing session the analysers were calibrated using known concentrations. The volume transducer was calibrated using a 3-litre syringe (Hans Rudolph, Kansas City, MO, USA). When we refer to the oxygen cost of exercise we are referring to end exercise oxygen uptake.
Measured: 3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart
Secondary outcomes (1)
Functional capacity measured by 6-Minute Walking Test (6MWT)
Measured: 6 minutes walking per participant per visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionAug 2013
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 Type 2 DiabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK
- Responsible party
- Sponsor
- Investigators
- Daryl Wilkerson, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206074
- Sponsor's protocol ID
- CRF107
- Other IDs
- 12/SW/0118
- Acronym
- Ex nit as
- Status last verified
- Mar 2019
- First submitted
- 25 Jul 2014
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Shepherd AI, Gilchrist M, Winyard PG, Jones AM, Hallmann E, Kazimierczak R, Rembialkowska E, Benjamin N, Shore AC, Wilkerson DP. Effects of dietary nitrate supplementation on the oxygen cost of exercise and walking performance in individuals with type 2 diabetes: a randomized, double-blind, placebo-controlled crossover trial. Free Radic Biol Med. 2015 Sep;86:200-8. doi: 10.1016/j.freeradbiomed.2015.05.014. Epub 2015 May 18.
PubMed 25998421
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Nitrate Supplementation on Ability of Individuals With Type 2 Diabetes to Perform Exercise
- ClinicalTrials.gov ID
- NCT02206074
- Acronym / sponsor ID
- Ex nit as / CRF107
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Diabetes UK
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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 investigators are conducting a research study to see if increasing the amount of nitrate (a substance found in large quantities in certain vegetables) in the diet can increase the ability of individuals with Type 2 diabetes (T2D) to perform exercise. Some people with T2D find exercise more uncomfortable than individuals who do not have T2D. This may be explained by the experimental studies showing that T2D can result in reductions in the supply of oxygen to the muscles. Studies have also shown that for a given level of activity, individuals with T2D will be much closer to their maximum exercise capacity than healthy individuals. Dietary nitrate may have two important beneficial effects in individuals with T2D: 1) The effects of dietary nitrate on the responses to exercise may have a significant impact on the ability of individuals with Type 2 diabetes to perform daily tasks and exercise more comfortably and 2) experimental studies suggest that increased nitrate consumption has been shown to reduce the amount of oxygen required for a given level of exercise.
The investigators will recruit 60 individuals with T2D. These people will take part in a randomised crossover design study where they will be asked to drink normal beetroot juice (rich in nitrate) and nitrate depleted beetroot juice, prior to performing two different walking exercise tasks (a six minute walk and repeated, low intensity treadmill walking). This study aims to determine if dietary nitrate supplementation reduces the amount of oxygen required for a given level of exercise in individuals with T2D. To test brain function individuals will be asked to perform a standard computerised decision making task following consumption of the nitrate rich and nitrate depleted juices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM | Active comparator | Dietary Supplement: BeetrootCrossover design where participants will start in the Beetroot juice condition, and after a washout period, move into the other condition. |
| Placebo | Placebo comparator | Dietary Supplement: BeetrootCrossover design where participants will start in the placebo condition, and after a washout period, move into the other condition. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with T2D (as defined by WHO) of at least 5 years duration between the ages of 35-75 will be invited.
Key exclusion criteria (6 listed)
- patients with significant renal impairment (eGFR<30)
- uncontrolled hypertension
- BMI<25 or >35
- are taking regular organic nitrates, nicorandil, or thiazolidinidiones, or any medication which may interfere with data interpretation or safety
- who have had a myocardial infarction or cerebro-vascular event
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 |
|---|---|---|
| BeetrootAlso: James Whites Drinks beetroot sports shot | Dietary supplement | Placebo, T2DM |
Primary outcome
Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems
Time frame: 3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart
Pulmonary gas exchange was measured during treadmill walking exercise (MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems, St. Paul, MN, USA). Prior to each testing session the analysers were calibrated using known concentrations. The volume transducer was calibrated using a 3-litre syringe (Hans Rudolph, Kansas City, MO, USA). When we refer to the oxygen cost of exercise we are referring to end exercise oxygen uptake.
1 secondary outcome
Functional capacity measured by 6-Minute Walking Test (6MWT)
Time frame: 6 minutes walking per participant per visit
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 19 Mar 2019.
- Derived from this study: PubMed 25998421Shepherd AI, Gilchrist M, Winyard PG, Jones AM, Hallmann E, Kazimierczak R, Rembialkowska E, Benjamin N, Shore AC, Wilkerson DP. Effects of dietary nitrate supplementation on the oxygen cost of exercise and walking performance in individuals with type 2 diabetes: a randomized, double-blind, placebo-controlled crossover trial. Free Radic Biol Med. 2015 Sep;86:200-8. doi: 10.1016/j.freeradbiomed.2015.05.014. Epub 2015 May 18.
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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.
Daryl Wilkerson, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot in people with Type 2 Diabetes, run by University of Exeter 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 1 inclusion and 6 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 19 Mar 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 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. 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?
Pulmonary gas exchange via MedGraphics CardiO2 Cardiopulmonary Diagnostic Systems (time frame: 3 x 6 minutes of gas exchange per participant, twice, 10-14 days apart). 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 NCT02206074, 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 19 Mar 2019.