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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 75
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
The University of Nottingham
RECRUITING
Nottingham
Contact Information
Primary
Moira A Taylor, PhD RD
Moira.Taylor@nottingham.ac.uk
+44 (0)115 823 0141
Backup
Mushari Alharbi, MBBS, MSc
Mushari.Alharbi@nottingham.ac.uk
+44 (0)115 823 0141
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2025-09
Participants
Target number of participants: 20
Treatments
Experimental: Dietary nitrate plus caloric restriction
Participants will drink beetroot juice with a calorie-restricted diet for 28 days.
Active_comparator: Dietary nitrate alone
Participants will drink beetroot juice with a weight-maintenance diet for 28 days.
Related Therapeutic Areas
Sponsors
Collaborators: King Abdulaziz University
Leads: Moira Taylor

This content was sourced from clinicaltrials.gov