RecruitingNAINTERVENTIONAL

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

This study is looking into how a healthy diet, specifically one including nitrate-rich beetroot juice, might improve brain function and blood vessel health in healthy people aged 60-75 who are overweight or obese. Participants will be split into two groups: one will drink beetroot juice daily along with a diet to reduce calories, and the other will drink the same juice with a diet designed to maintain their current weight. The study lasts 28 days, and all food and drink will be provided. Researchers will measure memory, thinking skills, blood pressure, and how blood flows in the brain. They also want to understand if this type of study is easy for people to take part in. This is a small, initial study to see if further research is worthwhile.

At a glance

Status

Recruiting

Phase

Sponsor

Moira Taylor

Enrolment target

Start

06 May 2024

Estimated completion

01 Sep 2025

Healthy Older Adults Overweight and Obesity

What is this study about?

This study is looking into whether drinking beetroot juice, which is rich in nitrates, combined with a special diet can improve memory, thinking skills, and the health of blood vessels, including those in the brain. They are particularly interested in healthy older adults, aged 60 to 75, who are overweight or obese. As we get older, our brain function and blood vessel health can sometimes change, and scientists are trying to find ways to keep them in good shape.

Research suggests that nitrates found in some foods like beetroot might help blood vessels work better. This study will provide all the food and beetroot juice for 28 days to look closely at these effects. It's designed to see if reducing calories (a calorie-restricted diet) while drinking beetroot juice helps more than just drinking beetroot juice with a diet that keeps your weight stable. The main goal is to see if brain function improves, but they'll also check blood pressure and how blood moves through your brain and other parts of your body.

This is a 'pilot study', which means it's a small, initial study. It’s like testing the waters to see if this approach has promise before doing a much larger study. They also want to make sure the study itself is practical and easy for people to participate in. The information gathered from this pilot will help guide future research into healthy ageing.

Key takeaways

A 28-day study investigating beetroot juice and diet for brain and blood vessel health.
Aimed at healthy people aged 60-75 who are overweight or obese.
Participants will follow either a calorie-restricted or weight-maintenance diet, with all food/drink provided.
Measures include memory, thinking, blood pressure, and blood flow in the brain.
This is a small 'pilot study' to explore potential benefits for healthy ageing.

Who may be eligible?

To be considered for this study, you need to be a healthy non-smoker, aged between 60 and 75 years old. Your Body Mass Index (BMI), which is a measure of your weight in relation to your height, should be between 25 and 40. This means you are considered overweight or obese. You also need to be able to understand information in English.

There are several reasons why you might not be able to join. For example, if your blood pressure is very high, or if you have certain medical conditions like diabetes, kidney problems, specific cancers, or have had brain surgery or a stroke. You also can't take part if you are on certain medications like diuretics, anti-acids, or some mental health drugs. If you've recently donated blood, drunk a lot of alcohol, are vegetarian (because of specific diet requirements for the study), or have difficulty with eating patterns, you might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 60 and 75 years old?
Are you a non-smoker?
Is your BMI between 25 and 40 (overweight or obese)?
Do you generally consider yourself healthy?
Do you not have conditions like diabetes, kidney problems, or severe high blood pressure?
Are you able to speak and understand English well?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit. During this visit, researchers will ask you about your health and medical history, check if you can have an MRI scan, and ask about your availability. They will measure your height, weight, and blood pressure, and you'll complete some questionnaires about your eating habits and physical activity. You will also have some blood tests.

If you qualify, you'll be randomly placed into one of two groups. For 28 days, you'll either follow a calorie-restricted diet or a weight-maintenance diet, and both groups will drink nitrate-rich beetroot juice daily. All your food and drink will be provided for the entire 28 days. You'll have two main visits to the study centre: one at the beginning (Day 0) and one at the end of the 28 days. During these visits, researchers will measure your brain function using paper-and-pen and computer tests. They will also measure your blood pressure both at the clinic and at home, check blood flow in your brain using an MRI scan, and measure blood flow in other small vessels. Your body measurements (height, weight, body fat) will be taken, and you'll give blood samples and breathe into a device to measure nitric oxide in your breath. You'll also wear a smartwatch to track your physical activity. The total duration of active participation in the diet part of the study is 28 days.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as you'll receive a carefully planned diet and beetroot juice, which could lead to improvements in your memory, thinking skills, and blood vessel health. However, there are also some potential risks. The diet might be different from what you're used to, and the calorie-restricted diet might cause temporary changes in your energy levels. You will have blood tests and an MRI scan, which are generally safe but have small associated risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The University of Nottingham
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is 'dietary nitrate'?

Dietary nitrate is a natural compound found in certain vegetables like beetroot. When you eat it, your body can change it into nitric oxide, which may help improve blood flow.

What is 'calorie restriction'?

Calorie restriction means eating fewer calories than usual, but still enough to get all the nutrients your body needs. It's designed to help with weight management.

Will I have to pay for the food or drink?

No, all the food and nitrate-rich beetroot juice for the 28-day study period will be provided to you by the researchers.

What does 'cognitive function' mean?

Cognitive function refers to your brain's abilities like memory, attention, problem-solving, and how quickly you can process information.

How long will I need to be involved in the study?

After your initial screening and eligibility checks, the diet and juice intervention will last for 28 days, with two main visits at the beginning and end of this period.

How to find out more

Moira A Taylor, PhD RD

Moira.Taylor@nottingham.ac.uk +44 (0)115 823 0141 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.