RecruitingNAINTERVENTIONAL

PROTeIn-rich Meals to Control Glucose

This study, called "PROTeIn-rich Meals to Control Glucose," aims to find the best diet for preventing and treating type 2 diabetes. It's specifically looking at how the timing of high-protein and high-carbohydrate meals affects blood sugar control and inflammation in people who are overweight, have prediabetes, or type 2 diabetes. Participants will try two different eating plans over several weeks, separated by a break. One plan involves a high-protein breakfast and high-carb dinner, while the other switches those around. The goal is to see which approach helps the body manage sugar levels more effectively and reduces inflammation.

At a glance

Status

Recruiting

Phase

Sponsor

German Institute of Human Nutrition

Enrolment target

Start

12 Apr 2024

Estimated completion

28 Feb 2027

Overweight Obesity Prediabetes Type 2 Diabetes

What is this study about?

This research is focused on a very common health challenge: managing blood sugar in people who are overweight, have prediabetes (meaning their blood sugar is higher than normal but not yet full-blown diabetes), or already have type 2 diabetes. The main idea behind this study is to explore if simply changing *when* you eat certain types of food – specifically protein and carbohydrates – can make a big difference in how well your body handles sugar and reduces inflammation.

Type 2 diabetes and prediabetes are often linked to how our bodies process food, especially sugars. Inflammation can also play a role in these conditions. By carefully looking at two different eating patterns, scientists hope to learn more about how diet can be used as a tool to improve health for these groups. Understanding this could lead to more effective and practical advice for people looking to improve their health.

The study is comparing two ways of eating: one where breakfast is high in protein and dinner is higher in carbohydrates, and another where it's the other way around. Both diets will have the same total amount of calories, so it's not about eating more or less, but about the *timing* of these key nutrients. The results could offer valuable insights into personalising dietary advice for better blood sugar control and overall well-being.

Key takeaways

This study explores how meal timing affects blood sugar in prediabetes and type 2 diabetes.
It compares eating a high-protein breakfast versus a high-protein dinner.
Your participation could help improve dietary advice for managing diabetes.
The study lasts about 12 weeks, including breaks between diet phases.
You must be overweight or have obesity, with prediabetes or non-insulin-treated type 2 diabetes.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old. You should either have prediabetes (meaning your fasting blood sugar is between 5.6 and 6.9 mmol/L) or type 2 diabetes (where your fasting blood sugar is 7.0 mmol/L or higher). Additionally, you should be considered overweight or have obesity, with a Body Mass Index (BMI) between 25 and 50.

There are several reasons why someone might not be able to join. For example, if you are currently taking insulin for your diabetes, you wouldn't be suitable. The study also excludes people who have had significant weight changes recently (more than a 5% change in the last three months) or who work night shifts, as this can affect eating patterns. Certain health conditions, like severe heart, liver, or kidney problems, severe anaemia, uncontrolled high blood pressure (above 180/110 mmHg), or some immune diseases, would also prevent participation.

Other reasons for not being able to join include if you've had cancer in the last two years, have an eating disorder, food allergies or intolerances to typical foods, or if you regularly take blood thinners that can't be stopped. Also, if you are pregnant or breastfeeding, or if you have any other severe medical or mental health condition or take medicines that might interfere with the study's results, you wouldn't be able to participate. The study is open to both men and women.

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 18 and 75 years old?
Do you have prediabetes or type 2 diabetes (not treated with insulin)?
Are you considered overweight or obese (BMI 25-50)?
Do you have any severe heart, liver, or kidney problems?
Have you had significant, unplanned weight changes lately (more than 5% in 3 months)?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be on two different diet plans, each lasting 4 weeks. These diet phases will be separated by a 4-week 'wash-out' period, where you'll return to your usual eating habits. Because it's a 'cross-over design', you'll try both diets at different times. This means you'll be part of the study for a total of about 12 weeks (4 weeks diet A + 4 weeks break + 4 weeks diet B).

During the study, you'll be asked to follow specific meal plans for breakfast, lunch, and dinner, which will be provided or clearly outlined. You won't be taking any new medication specifically for the study. The researchers will likely monitor your blood sugar levels and other health markers throughout the intervention periods and at the start and end of the study. This might involve blood tests. Specific details on the number of clinic visits or assessments would be provided by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as gaining a better understanding of how your diet affects your blood sugar and overall health, which could help you manage your condition more effectively. You would also be contributing to medical research that could help many others with prediabetes and type 2 diabetes. As with any diet change, you might experience minor, temporary side effects like digestive changes. All food will be carefully planned to be safe, but if you have any known food intolerances, you should discuss these with the study team. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Olga Ramich
Verified postcode
Potsdam, Germany· Recruiting

Common questions

What is prediabetes?

Prediabetes means your blood sugar levels are higher than normal, but not high enough to be diagnosed as type 2 diabetes. It's a warning sign that you're at increased risk for developing type 2 diabetes.

What does 'macronutrient composition' mean?

Macronutrients are the main types of food your body needs in large amounts: proteins, carbohydrates, and fats. The study is looking at how changing the amounts of these in different meals, like breakfast or dinner, affects your health.

What is a 'cross-over design'?

A cross-over design means you will try all the different diets or treatments being tested, but at different times. This allows researchers to compare the effects of each diet on the same person.

Will I have to prepare my own meals?

The study aims to provide clear guidance on what to eat, or may provide some meals. Specific details on meal preparation and provision will be given by the study team.

Will I know which diet I'm on?

Yes, you will know whether you are on the diet with high-protein breakfast or high-protein dinner. This is not a 'blinded' study regarding the diet plans.

How to find out more

Olga Ramich, PD Dr.

olga.ramich@dife.de +4933200882749 Official trial record

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