Active not recruitingNAINTERVENTIONAL

Enteral Nutrition and Immune Proteins Study

This study aims to understand how a special milkshake diet affects the immune system and gut bacteria in healthy adults. If you join, you'll be randomly chosen to replace all or half of your normal daily food with a special milkshake for seven days. This helps make sure the study results are fair. Before starting the diet, we'll ask for your height and weight, and samples of your blood, poo, and wee. You'll also keep a food diary. During and after the seven-day diet, we'll ask for more samples to see how your immune cells, proteins, and gut bacteria have changed. Those having half milkshake meals will also complete another short food diary.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Glasgow

Enrolment target

Start

01 Mar 2023

Estimated completion

21 Nov 2025

Healthy Adults

What is this study about?

This study is called the "Enteral Nutrition and Immune Proteins Study." We want to learn more about how a particular type of diet, which uses a special milkshake as a complete or partial meal replacement, affects your body. Specifically, we're interested in how this diet influences your immune system (your body's defence against illness) and the bacteria that naturally live in your gut. These tiny bacteria are very important for your health.

We're asking healthy adult volunteers to take part. You'll be randomly assigned to one of two groups: one group will have the special milkshake as their only food for seven days, while the other group will have the milkshake for half of their food and eat normal meals for the rest. This random assignment helps us make sure the study is fair and that any changes we see are truly due to the diet, not other factors. By taking blood, poo, and wee samples before, during, and after the diet, we can get a clear picture of how your body responds.

The information we gather from this study is really important. It will help us understand more about the link between what we eat and how our immune system works, as well as the health of our gut. This knowledge could eventually help doctors and scientists understand how to better support people's health through diet in the future. We're not making any medical recommendations, but simply gathering information.

Key takeaways

This study helps understand diet's effect on your immune system.
You'll drink a special milkshake for 7 days (all or half meals).
Blood, poo, and wee samples are collected before, during, and after.
You'll keep a food diary at certain times.
Participation contributes to important health research.

Who may be eligible?

This study is looking for healthy adults, aged 18 or older.

However, there are some reasons why you might not be able to join. You can't take part if you have an ongoing health condition that requires regular visits to a doctor or clinic, or if your weight has changed by more than 2 kg (about 4.4 pounds) in the last month. Also, if you've had surgery on your gut in the past, or if you've taken antibiotics or steroid medications in the last month, you won't be eligible.

Additionally, if you have allergies to milk protein (as the special milkshake contains this), or if you are currently pregnant or breastfeeding, unfortunately, you won't be able to participate in this study.

Quick self-check

Are you 18 years old or older?
Are you generally healthy, without ongoing serious illnesses?
Has your weight been stable (no more than 2kg up or down) in the last month?
Have you avoided antibiotics or steroid medicines in the last month?
Are you NOT pregnant or breastfeeding?
Do you NOT have a milk protein allergy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first be asked to give your consent (meaning you agree to join). Then, you'll provide your height and weight measurements. In the week leading up to starting the special diet, you'll be asked to provide blood samples, collect samples of your poo (stool) and wee (urine), and keep a detailed food diary for three specific days (seven, four, and one day before the diet starts). This diary will ask what you eat and drink using common measurements like a teaspoon or cup.

On the day you start the special milkshake diet, you'll have another weight check, blood test, and provide more poo and wee samples. You'll then follow your allocated diet for seven days (either all milkshake or half milkshake, half normal food). If you're in the half-milkshake group, you'll also keep another food diary for three days during this week. At the end of the seven days, you'll have one final weight measurement, blood test, and provide your last poo and wee samples. We don't expect any long-term follow-up beyond these seven days of dietary intervention.

Potential risks and benefits

The main benefit of taking part is contributing to scientific knowledge about diet, the immune system, and gut health. However, there are some potential risks. Blood tests can cause a little discomfort or bruising. The milkshake might taste different to your usual food, and some people might experience minor gut changes, although this is generally a safe diet. You might also find recording your food and collecting samples a bit inconvenient. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Glasgow
Glasgow, United Kingdom

Common questions

What is 'enteral nutrition'?

It's a way of providing food using special liquid formulas, like a milkshake, that you drink. It contains all the nutrients your body needs.

Will I know which diet I'm on?

Yes, you'll be told if you're having the milkshake for all your meals or for half your meals for the seven days.

What do the blood tests look for?

They're used to see how your immune system's cells and proteins respond to the special diet.

Why do you need poo and wee samples?

These samples help us understand how the different bacteria in your gut change during the diet and how your body processes things.

Will I be paid to take part?

The information provided only mentions that participants are volunteers, it does not state if payment will be given.