The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function.
Recruiting · NCT06151015 · Interventional (participants receive a specific treatment) · Lead sponsor: Moira Taylor
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- 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).
Where it is running
1 location listed.
- The University of Nottingham - Nottingham, Nottinghamshire, United Kingdom