Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06151015
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-11-06
Brief Title:
The Combined Effect of Dietary Nitrate and Caloric Restriction on Cognitive and Vascular Function
Sponsor:
Moira Taylor
Organization:
University of Nottingham
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRNitrateMRI
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 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
Detailed Description:
Twenty healthy males and females aged 60-70 years non-smokers and living with overweight or obesity BMI 25-40 kgm2 will be recruited to a 28-day pilot randomised parallel trial to follow one of the interventions dietary nitrate with calorie-restricted diet or dietary nitrate with weight-maintenance diet if they are eligible Their energy requirement will be calculated using the Mifflin-St Jeor Equation and the participant will be instructed to follow a healthy diet pre-diet standardisation for three days before the intervention to minimise the effect of the sudden change of their habitual diet during which their energy requirement will be met At the Baseline Visit Day 0 they will be randomised to one of the two arms and the outcome measurements will be taken Cognitive function will be measured via a pen-and-paper test TMT and a cognitive battery of tests COMPASS Clinic and home resting blood pressure BP will be measured using an automated BP monitor Microvascular perfusion will be measured by a Laser Doppler monitor Cerebral blood flow will be measured using a brain MRI scan Height weight BMI skinfold thickness and waist circumference will be measured via a wall-mounted stadiometer calibrated scale BMI equation calipers and a tape measure respectively Body composition will be measured by a bioelectrical impedance analysis BIA Exhaled NO will be measured using a fractional exhaled nitric oxide analyser FeNO Blood samples will be taken to measure plasma nitrate concentrations Physical activity will be monitored through a wearable smartwatch with an integrated accelerometer The participants will be provided with 14 bottles of nitrate-rich beetroot juice 70 ml which provides 65mmol of nitrateday with their allocated diet to be consumed in the next 14 days starting from the next day Day 1 and the remaining 14 days supply will be delivered on Day 13 There will be an energy deficit of 1000 kcalday if they are allocated to the caloric restriction group Otherwise the energy requirement will be met After completing the 28-day intervention the participant will attend the End Visit Day 29 to repeat the same study measurements they have done in the Baseline Visit An exit feedback questionnaire will be given to collect information on the acceptability and compliance with the measurement protocols and intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None