HealthyCRNitrateMRINCT06151015
The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function.
A study testing Nitrate-rich beetroot juice plus calorie-restricted diet and Nitrate-rich beetroot juice plus weight-maintenance diet in people with Healthy and Older Adults, run by Moira Taylor at 1 site in United Kingdom.
Trial summary
This pilot study will compare the effect of combining dietary nitrate and caloric restriction versus dietary nitrate alone. The participant will be contacted, having responded to an advertisement on social media and posters, to attend the screening visit. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Older Adults, Overweight and Obesity
- What is being tested?
- Nitrate-rich beetroot juice plus calorie-restricted diet and Nitrate-rich beetroot juice plus weight-maintenance diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is able to give written informed consent for their participation in the study.
- Healthy.
- Non-smoking adults.
- Male or female.
- Aged 60 to 75 years.
- BMI between 25 and 40 kg/m2.
Who cannot join
- Systolic BP > 180mmHg and/or diastolic BP >110mmHg at the Clinic Screening Visit.
- Contraindication for MRI.
- Does not have adequate understanding of verbal and written information in English, sufficient to complete an MRI safety screening and to give informed consent.
- Any existing or previous medical condition that may affect the study outcomes (i.e., diabetes, kidney dysfunction, malignant cancer, brain surgery, stroke).
- Any medical treatment that may affect the study outcomes (i.e., diuretics, anti-acids, organic nitrates, anti-pyschotics or neuro-stimulants).
- Evidence of an eating disorder as indicated by the Three-factor eating questionnaire (Eating Attitudes Tests-26).
Show all 11Show fewer
- Blood donation within the last 3 months of the anticipated intervention beginnings.
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
- High-alcohol consumers (≥ 14 units/week for females, and ≥ 22 units/week for males).
- Vegetarianism (likely to have very high nitrate intake and food provided during the dietary intervention unsuitable).
- Weight change over 3.0kg in the last 2 months (important influence on vascular function).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
Mushari Alharbi, MBBS, MSc, +44 (0)115 823 0141, Mushari.Alharbi@nottingham.ac.uk
Moira A Taylor, PhD RD, +44 (0)115 823 0141, Moira.Taylor@nottingham.ac.uk
About this study
Official title: Testing the Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function in Older Adults Living with Overweight or Obesity: a 28-Day Pilot Randomised Trial
This pilot study will compare the effect of combining dietary nitrate and caloric restriction versus dietary nitrate alone. The participant will be contacted, having responded to an advertisement on social media and posters, to attend the screening visit. They will be asked about their health status, suitability for MRI and availability. The investigators will use physical activity and eating attitude questionnaires. The investigators will also measure their height, weight, body mass index (BMI), and blood pressure (BP) and undertake blood tests. If they are eligible, they will be randomised to one of the two arms. The first group will consume nitrate-rich beetroot juice with a calorie-restricted diet for 28 days. The second group will drink the same juice with a weight-maintenance diet for the same period. The food and drinks will be provided. The outcome measures will be measured twice (at the baseline and end visits) to evaluate the change. The primary outcome is the cognitive function. The secondary outcomes are peripheral vascular health (BP and microvascular perfusion), cerebral vascular health (brain blood flow), anthropometry, body composition, and exhaled NO and nitrate concentrations. Also, the feasibility and accessibility of the study will be assessed.
Read the detailed description
Twenty healthy males and females, aged 60-70 years, non-smokers, and living with overweight or obesity (BMI 25-40 kg/m2) will be recruited to a 28-day pilot, randomised, parallel trial to follow one of the interventions (dietary nitrate with calorie-restricted diet or dietary nitrate with weight-maintenance diet) if they are eligible. Their energy requirement will be calculated using the Mifflin-St Jeor Equation, and the participant will be instructed to follow a healthy diet ( pre-diet standardisation) for three days before the intervention to minimise the effect of the sudden change of their habitual diet (during which their energy requirement will be met). At the Baseline Visit (Day 0), they will be randomised to one of the two arms, and the outcome measurements will be taken. Cognitive function will be measured via a pen-and-paper test (TMT) and a cognitive battery of tests (COMPASS). Clinic and home resting blood pressure (BP) will be measured using an automated BP monitor. Microvascular perfusion will be measured by a Laser Doppler monitor. Cerebral blood flow will be measured using a brain MRI scan. Height, weight, BMI, skinfold thickness, and waist circumference will be measured via a wall-mounted stadiometer, calibrated scale, BMI equation, calipers, and a tape measure, respectively. Body composition will be measured by a bioelectrical impedance analysis (BIA). Exhaled NO will be measured using a fractional exhaled nitric oxide analyser (FeNO). Blood samples will be taken to measure plasma nitrate concentrations. Physical activity will be monitored through a wearable smartwatch with an integrated accelerometer. The participants will be provided with 14 bottles of nitrate-rich beetroot juice (70 ml, which provides 6.5mmol of nitrate/day) with their allocated diet to be consumed in the next 14 days, starting from the next day (Day 1), and the remaining 14 days' supply will be delivered on Day 13. There will be an energy deficit of 1,000 kcal/day if they are allocated to the caloric restriction group. Otherwise, the energy requirement will be met. After completing the 28-day intervention, the participant will attend the End Visit (Day 29), to repeat the same study measurements they have done in the Baseline Visit. An exit feedback questionnaire will be given to collect information on the acceptability and compliance with the measurement protocols and intervention.
- Conditions
- Healthy, Older Adults, Overweight and Obesity
- Being tested
- Nitrate-rich beetroot juice plus calorie-restricted diet, Nitrate-rich beetroot juice plus weight-maintenance diet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate-rich beetroot juice plus calorie-restricted dietOther
One daily bottle (70ml) of nitrate-rich beetroot juice with a calorie-restricted diet (1,000kcal deficit).
Nitrate-rich beetroot juice plus weight-maintenance dietOther
One daily bottle (70ml) of nitrate-rich beetroot juice with a weight-maintenance diet (energy will be met).
| Study group | Role | What they receive |
|---|---|---|
| Dietary nitrate plus caloric restriction | Experimental | Participants will drink beetroot juice with a calorie-restricted diet for 28 days. Receives: Other: Nitrate-rich beetroot juice plus calorie-restricted diet |
| Dietary nitrate alone | Active comparator | Participants will drink beetroot juice with a weight-maintenance diet for 28 days. Receives: Other: Nitrate-rich beetroot juice plus weight-maintenance diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function (TMT-B)
Change in cognitive function from the baseline after 28 days intervention using a pen-and-paper cognitive test (TMT-B) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Secondary outcomes (20)
Composite score of cognitive function
Change in the composite score of cognitive function from the baseline after 28 days intervention using a computerised cognitive battery (COMPASS) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual tasks (alphabetic working memory)
Change in the cognitive function of individual task (alphabetic working memory) from the baseline after 28 days of intervention using a computerised cognitive battery (COMPASS) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual task (serial subtraction)
Change in the cognitive function of individual task (serial subtraction) from the baseline after 28 days of intervention using a computerised cognitive battery (COMPASS) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual task (stroop)
Change in the cognitive function of individual task (stroop) from the baseline after 28 days of intervention using a computerised cognitive battery (COMPASS) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual task (peg and ball)
Change in the cognitive function of individual task (peg and ball) from the baseline after 28 days of intervention using a computerised cognitive battery (COMPASS) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual task (simple reaction time)
Change in the cognitive function of individual task (simple reaction time) from the baseline after 28 days of intervention using a computerised cognitive battery (COMPASS) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function (TMT-A)
Change in cognitive function from the baseline after 28 days intervention using a pen-and-paper cognitive test (TMT-A) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Clinic blood pressure for systolic and diastolic pressure
Change in clinic blood pressure (systolic and diastolic pressure) from the baseline after 28 days intervention using automated blood pressure device compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Continuous home blood pressure for systolic and diastolic pressure
Changes in home blood pressure (systolic and diastolic pressure) from the first day of the intervention until last day using an automated blood pressure device compared to the comparator.
Measured: Every three days starting from Day 1 until Day 28 of the intervention.
Microvascular perfusion
Change in microvascular perfusion from the baseline after 28 days intervention using a Laser Doppler monitor compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cerebral blood flow
Change in cerebral blood flow from the baseline after 28 days intervention using a brain MRI scan compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Anthropometry (weight)
Change in weight in kilograms from the baseline after 28 days intervention using a calibrated scale compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Anthropometry (BMI)
Change in BMI in kg/m^2 from the baseline after 28 days intervention using the BMI equation (weight and height will be combined to report BMI in kg/m^2) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Anthropometry (skinfold thickness)
Change in skinfold thickness in millimetre from the baseline after 28 days intervention using a skinfold calipers, compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Anthropometry (waist circumference)
Change in waist circumference from the baseline after 28 days intervention using a tape measure compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Body composition (fat mass)
Change in body composition (fat mass in kg) from the baseline after 28 days intervention using a bioelectrical impedance analysis (BIA) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Body composition (fat-free mass)
Change in body composition (fat-free mass in kg) from the baseline after 28 days intervention using a bioelectrical impedance analysis (BIA) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Exhaled nitric oxide
Change in nitric oxide from the baseline after 28 days intervention using a fractional exhaled nitric oxide analyser (FeNO) compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Nitrate concentrations
Change in plasma nitrate concentrations from the baseline after 28 days intervention using an Ozone-based chemiluminescence compared to the comparator.
Measured: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Feasibility and accessibility
A paper exit feedback questionnaire will be administered at the end of the study to collect information on the acceptability and compliance with the measurement protocols and intervention.
Measured: End Visit (Day 29).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start6 May 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, randomised, parallel trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moira Taylor
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz University
- Responsible party
- Sponsor-investigator, Moira Taylor, University of Nottingham
- Investigators
- Moira A Taylor, PhD RD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151015
- Sponsor's protocol ID
- 323-0723
- Acronym
- CRNitrateMRI
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2023
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis.
Publications
Alharbi M, Stephan BC, Shannon OM, Siervo M. Does dietary nitrate boost the effects of caloric restriction on brain health? Potential physiological mechanisms and implications for future research. Nutr Metab (Lond). 2023 Oct 25;20(1):45. doi: 10.1186/s12986-023-00766-9.
PubMed 37880786Alharbi M, Chiurazzi M, Nasti G, Muscariello E, Mastantuono T, Koechl C, Stephan BC, Shannon OM, Colantuoni A, Siervo M. Caloric Restriction (CR) Plus High-Nitrate Beetroot Juice Does Not Amplify CR-Induced Metabolic Adaptation and Improves Vascular and Cognitive Functions in Overweight Adults: A 14-Day Pilot Randomised Trial. Nutrients. 2023 Feb 10;15(4):890. doi: 10.3390/nu15040890.
PubMed 36839248Babateen AM, Shannon OM, O'Brien GM, Olgacer D, Koehl C, Fostier W, Mathers JC, Siervo M. Moderate doses of dietary nitrate elicit greater effects on blood pressure and endothelial function than a high dose: A 13-week pilot study. Nutr Metab Cardiovasc Dis. 2023 Jun;33(6):1263-1267. doi: 10.1016/j.numecd.2023.02.024. Epub 2023 Mar 2.
PubMed 36958967Shannon OM, Gregory S, Siervo M. Dietary nitrate, aging and brain health: the latest evidence. Curr Opin Clin Nutr Metab Care. 2022 Nov 1;25(6):393-400. doi: 10.1097/MCO.0000000000000866. Epub 2022 Aug 9.
PubMed 35943128Siervo M, Babateen A, Alharbi M, Stephan B, Shannon O. Dietary nitrate and brain health. Too much ado about nothing or a solution for dementia prevention? Br J Nutr. 2022 Sep 28;128(6):1130-1136. doi: 10.1017/S0007114522002434.
PubMed 36688430Babateen AM, Shannon OM, O'Brien GM, Okello E, Smith E, Olgacer D, Koehl C, Fostier W, Wightman E, Kennedy D, Mathers JC, Siervo M. Incremental Doses of Nitrate-Rich Beetroot Juice Do Not Modify Cognitive Function and Cerebral Blood Flow in Overweight and Obese Older Adults: A 13-Week Pilot Randomised Clinical Trial. Nutrients. 2022 Mar 2;14(5):1052. doi: 10.3390/nu14051052.
PubMed 35268027Siervo M, Arnold R, Wells JC, Tagliabue A, Colantuoni A, Albanese E, Brayne C, Stephan BC. Intentional weight loss in overweight and obese individuals and cognitive function: a systematic review and meta-analysis. Obes Rev. 2011 Nov;12(11):968-83. doi: 10.1111/j.1467-789X.2011.00903.x. Epub 2011 Jul 18.
PubMed 21762426
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function in Older Adults Living with Overweight or Obesity: a 28-Day Pilot Randomised Trial
- ClinicalTrials.gov ID
- NCT06151015
- Acronym / sponsor ID
- CRNitrateMRI / 323-0723
- Conditions
- Healthy, Older Adults, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Moira TaylorUniversity, hospital or other
- Collaborators
- King Abdulaziz University
- Study start
- 6 May 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 30 Nov 2023 (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.
This pilot study will compare the effect of combining dietary nitrate and caloric restriction versus dietary nitrate alone. The participant will be contacted, having responded to an advertisement on social media and posters, to attend the screening visit. They will be asked about their health status, suitability for MRI and availability. The investigators will use physical activity and eating attitude questionnaires. The investigators will also measure their height, weight, body mass index (BMI), and blood pressure (BP) and undertake blood tests. If they are eligible, they will be randomised to one of the two arms. The first group will consume nitrate-rich beetroot juice with a calorie-restricted diet for 28 days. The second group will drink the same juice with a weight-maintenance diet for the same period. The food and drinks will be provided. The outcome measures will be measured twice (at the baseline and end visits) to evaluate the change. The primary outcome is the cognitive function. The secondary outcomes are peripheral vascular health (BP and microvascular perfusion), cerebral vascular health (brain blood flow), anthropometry, body composition, and exhaled NO and nitrate concentrations. Also, the feasibility and accessibility of the study will be assessed.
Detailed description
Twenty healthy males and females, aged 60-70 years, non-smokers, and living with overweight or obesity (BMI 25-40 kg/m2) will be recruited to a 28-day pilot, randomised, parallel trial to follow one of the interventions (dietary nitrate with calorie-restricted diet or dietary nitrate with weight-maintenance diet) if they are eligible. Their energy requirement will be calculated using the Mifflin-St Jeor Equation, and the participant will be instructed to follow a healthy diet ( pre-diet standardisation) for three days before the intervention to minimise the effect of the sudden change of their habitual diet (during which their energy requirement will be met). At the Baseline Visit (Day 0), they will be randomised to one of the two arms, and the outcome measurements will be taken. Cognitive function will be measured via a pen-and-paper test (TMT) and a cognitive battery of tests (COMPASS). Clinic and home resting blood pressure (BP) will be measured using an automated BP monitor. Microvascular perfusion will be measured by a Laser Doppler monitor. Cerebral blood flow will be measured using a brain MRI scan. Height, weight, BMI, skinfold thickness, and waist circumference will be measured via a wall-mounted stadiometer, calibrated scale, BMI equation, calipers, and a tape measure, respectively. Body composition will be measured by a bioelectrical impedance analysis (BIA). Exhaled NO will be measured using a fractional exhaled nitric oxide analyser (FeNO). Blood samples will be taken to measure plasma nitrate concentrations. Physical activity will be monitored through a wearable smartwatch with an integrated accelerometer. The participants will be provided with 14 bottles of nitrate-rich beetroot juice (70 ml, which provides 6.5mmol of nitrate/day) with their allocated diet to be consumed in the next 14 days, starting from the next day (Day 1), and the remaining 14 days' supply will be delivered on Day 13. There will be an energy deficit of 1,000 kcal/day if they are allocated to the caloric restriction group. Otherwise, the energy requirement will be met. After completing the 28-day intervention, the participant will attend the End Visit (Day 29), to repeat the same study measurements they have done in the Baseline Visit. An exit feedback questionnaire will be given to collect information on the acceptability and compliance with the measurement protocols and intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, randomised, parallel trial
| Arm | Type | Receives |
|---|---|---|
| Dietary nitrate plus caloric restriction | Experimental | Other: Nitrate-rich beetroot juice plus calorie-restricted dietParticipants will drink beetroot juice with a calorie-restricted diet for 28 days. |
| Dietary nitrate alone | Active comparator | Other: Nitrate-rich beetroot juice plus weight-maintenance dietParticipants will drink beetroot juice with a weight-maintenance diet for 28 days. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is able to give written informed consent for their participation in the study.
- Healthy.
- Non-smoking adults.
- Male or female.
- Aged 60 to 75 years.
Key exclusion criteria (11 listed)
- Systolic BP > 180mmHg and/or diastolic BP >110mmHg at the Clinic Screening Visit.
- Contraindication for MRI.
- Does not have adequate understanding of verbal and written information in English, sufficient to complete an MRI safety screening and to give informed consent.
- Any existing or previous medical condition that may affect the study outcomes (i.e., diabetes, kidney dysfunction, malignant cancer, brain surgery, stroke).
- Any medical treatment that may affect the study outcomes (i.e., diuretics, anti-acids, organic nitrates, anti-pyschotics or neuro-stimulants).
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 |
|---|---|---|
| Nitrate-rich beetroot juice plus calorie-restricted dietOne daily bottle (70ml) of nitrate-rich beetroot juice with a calorie-restricted diet (1,000kcal deficit). | Other | Dietary nitrate plus caloric restriction |
| Nitrate-rich beetroot juice plus weight-maintenance dietOne daily bottle (70ml) of nitrate-rich beetroot juice with a weight-maintenance diet (energy will be met). | Other | Dietary nitrate alone |
Primary outcome
Cognitive function (TMT-B)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Change in cognitive function from the baseline after 28 days intervention using a pen-and-paper cognitive test (TMT-B) compared to the comparator.
20 secondary outcomes
Composite score of cognitive function
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual tasks (alphabetic working memory)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual task (serial subtraction)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual task (stroop)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual task (peg and ball)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function individual task (simple reaction time)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cognitive function (TMT-A)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Clinic blood pressure for systolic and diastolic pressure
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Continuous home blood pressure for systolic and diastolic pressure
Time frame: Every three days starting from Day 1 until Day 28 of the intervention.
Microvascular perfusion
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Cerebral blood flow
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Anthropometry (weight)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Anthropometry (BMI)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Anthropometry (skinfold thickness)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Anthropometry (waist circumference)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Body composition (fat mass)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Body composition (fat-free mass)
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Exhaled nitric oxide
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Nitrate concentrations
Time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.
Feasibility and accessibility
Time frame: End Visit (Day 29).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 37880786Alharbi M, Stephan BC, Shannon OM, Siervo M. Does dietary nitrate boost the effects of caloric restriction on brain health? Potential physiological mechanisms and implications for future research. Nutr Metab (Lond). 2023 Oct 25;20(1):45. doi: 10.1186/s12986-023-00766-9.
- Background: PubMed 36839248Alharbi M, Chiurazzi M, Nasti G, Muscariello E, Mastantuono T, Koechl C, Stephan BC, Shannon OM, Colantuoni A, Siervo M. Caloric Restriction (CR) Plus High-Nitrate Beetroot Juice Does Not Amplify CR-Induced Metabolic Adaptation and Improves Vascular and Cognitive Functions in Overweight Adults: A 14-Day Pilot Randomised Trial. Nutrients. 2023 Feb 10;15(4):890. doi: 10.3390/nu15040890.
- Background: PubMed 36958967Babateen AM, Shannon OM, O'Brien GM, Olgacer D, Koehl C, Fostier W, Mathers JC, Siervo M. Moderate doses of dietary nitrate elicit greater effects on blood pressure and endothelial function than a high dose: A 13-week pilot study. Nutr Metab Cardiovasc Dis. 2023 Jun;33(6):1263-1267. doi: 10.1016/j.numecd.2023.02.024. Epub 2023 Mar 2.
- Background: PubMed 35943128Shannon OM, Gregory S, Siervo M. Dietary nitrate, aging and brain health: the latest evidence. Curr Opin Clin Nutr Metab Care. 2022 Nov 1;25(6):393-400. doi: 10.1097/MCO.0000000000000866. Epub 2022 Aug 9.
- Background: PubMed 36688430Siervo M, Babateen A, Alharbi M, Stephan B, Shannon O. Dietary nitrate and brain health. Too much ado about nothing or a solution for dementia prevention? Br J Nutr. 2022 Sep 28;128(6):1130-1136. doi: 10.1017/S0007114522002434.
- Background: PubMed 35268027Babateen AM, Shannon OM, O'Brien GM, Okello E, Smith E, Olgacer D, Koehl C, Fostier W, Wightman E, Kennedy D, Mathers JC, Siervo M. Incremental Doses of Nitrate-Rich Beetroot Juice Do Not Modify Cognitive Function and Cerebral Blood Flow in Overweight and Obese Older Adults: A 13-Week Pilot Randomised Clinical Trial. Nutrients. 2022 Mar 2;14(5):1052. doi: 10.3390/nu14051052.
- Background: PubMed 21762426Siervo M, Arnold R, Wells JC, Tagliabue A, Colantuoni A, Albanese E, Brayne C, Stephan BC. Intentional weight loss in overweight and obese individuals and cognitive function: a systematic review and meta-analysis. Obes Rev. 2011 Nov;12(11):968-83. doi: 10.1111/j.1467-789X.2011.00903.x. Epub 2011 Jul 18.
- Individual participant dataSharing planned: Yes. Only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Moira A Taylor, PhD RD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate-rich beetroot juice plus calorie-restricted diet and Nitrate-rich beetroot juice plus weight-maintenance diet in people with Healthy and Older Adults, run by Moira Taylor 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 24 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moira A Taylor, PhD RD (+44 (0)115 823 0141, Moira.Taylor@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (TMT-B) (time frame: Baseline Visit (Day 0)-one day before intervention, and End Visit (Day 29)-one day after intervention.). 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 NCT06151015, which also lists 7 linked publications.
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 24 Dec 2024.