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Search / Trial NCT06151015

The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function.

Launched by MOIRA TAYLOR · Nov 27, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how a special drink made from beetroot, which is high in dietary nitrate, combined with a reduced-calorie diet affects brain and blood vessel health in healthy older adults who are overweight or obese. Researchers want to see if this combination is more beneficial than just drinking the beetroot juice without cutting calories. If you’re between 60 and 75 years old, healthy, and a non-smoker with a body mass index (BMI) between 25 and 40, you may be eligible to participate.

Participants will be provided with the beetroot juice and specific meal plans for 28 days. Before starting, eligible individuals will undergo health screenings, including height, weight, blood pressure checks, and blood tests. They will also answer questions about their physical activity and eating habits. Throughout the study, researchers will measure changes in cognitive function (how well the brain works), blood flow, and body composition. This study aims to find out how these dietary changes can improve overall health in older adults, while also ensuring that the study is practical and accessible for participants.

Gender

ALL

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).

About Moira Taylor

Moira Taylor is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on ethical practices and stringent regulatory compliance, Moira Taylor collaborates with healthcare professionals and research institutions to design and implement high-quality clinical trials across various therapeutic areas. The organization emphasizes patient safety and data integrity, leveraging cutting-edge methodologies to contribute valuable insights to the scientific community and drive the development of new treatments.

Locations

Nottingham, Nottinghamshire, United Kingdom

Patients applied

0 patients applied

Trial Officials

Moira A Taylor, PhD RD

Principal Investigator

University of Nottingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported