NCT06151015Recruiting
The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function.
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
Source: ClinicalTrials.gov · Last updated 24 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 6 Nov 2023
- Start date
- 6 May 2024
- Primary completion date
- Sept 2025
- Lead sponsor
- Moira Taylor
- Diseases
- Obesity
- NCT number
- NCT06151015
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 6 May 2024 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any existing or previous medical condition that may affect the study outcomes (i.e., diabetes, kidney dysfunction, malignant cancer, brain surgery, stroke).
Other illness
- Evidence of an eating disorder as indicated by the Three-factor eating questionnaire (Eating Attitudes Tests-26).
Other
- 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 medical treatment that may affect the study outcomes (i.e., diuretics, anti-acids, organic nitrates, anti-pyschotics or neuro-stimulants).
- 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).
Who the study is looking for
- 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.
Age in the registry: 60 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Nottingham Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.