Combining dietary nitrate with calorie restriction to improve cognitive and vascular function in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the effects of dietary nitrate combined with caloric restriction compared to dietary nitrate alone on cognitive and vascular function in healthy older adults aged 60-70 years with overweight or obesity. Participants will be randomly assigned to consume nitrate-rich beetroot juice along with either a calorie-restricted diet or a weight-maintenance diet for 28 days. The study will assess various health metrics, including cognitive function through standardized tests, blood pressure, and microvascular perfusion using advanced monitoring techniques. The outcomes will be measured at baseline and after the intervention to evaluate any changes.

Why it matters

Who can join: the full rules

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's running

• The University of Nottingham
  Nottingham, Nottinghamshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Moira A Taylor, PhD RD — University of Nottingham
• Study coordinator: Moira A Taylor, PhD RD
• Email: Moira.Taylor@nottingham.ac.uk
• Phone: +44 (0)115 823 0141

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.