Status:
RECRUITING
The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function.
Lead Sponsor:
Moira Taylor
Collaborating Sponsors:
King Abdulaziz University
Conditions:
Healthy
Older Adults
Eligibility:
All Genders
60-75 years
Phase:
NA
Brief 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 s...
Detailed Description
Twenty healthy males and females, aged 60-70 years, non-smokers, and living with overweight or obesity (BMI 25-40 kg/m2) will be recruited to a 28-day pilot, randomised, parallel trial to follow one o...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06151015
Start Date
May 6 2024
End Date
September 1 2025
Last Update
December 24 2024
Active Locations (1)
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1
The University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD