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

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 study is testing if drinking beetroot juice while following a calorie-restricted diet can help improve thinking and blood flow in healthy older adults who are overweight or obese.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 60 Years to 75 Years
• Sex: All
• Sponsor: University of Nottingham (Academic / other)
• Locations: 1 site (Nottingham, Nottinghamshire)
• Trial ID: NCT06151015 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy, non-smoking adults aged 60 to 75 years with a BMI between 25 and 40 kg/m2.

Not a fit: Patients with significant medical conditions affecting study outcomes, such as diabetes or kidney dysfunction, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive and vascular health in older adults, potentially reducing the risk of cognitive decline.

How similar studies have performed: While the combination of dietary nitrate and caloric restriction is a novel approach, similar studies have shown promising results in improving health outcomes in older populations.

Eligibility criteria

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 this trial is running

Nottingham, Nottinghamshire

• 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

Conditions Healthy; Older Adults; Overweight and Obesity