RecruitingNAINTERVENTIONAL

Effects of Almonds in Glucose-intolerant Adults (AGAMEMNON)

The AGAMEMNON study is investigating if eating almonds can help people who have prediabetes and a common liver condition called Non-Alcoholic Fatty Liver Disease (NAFLD). Scientists already know that healthy foods like those in the Mediterranean diet, which includes nuts, can be good for your heart and help prevent serious conditions like type 2 diabetes. Almonds are rich in healthy fats and fibre, but it's not fully clear how much they contribute to these benefits. This study will follow 150 participants for 16 weeks to see if daily almond consumption, compared to no additional treatment, can improve blood sugar levels, reduce fat in the liver, and positively affect body composition and inflammation.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

150

Start

23 May 2024

Estimated completion

01 Jul 2026

PreDiabetes NAFLD

What is this study about?

This research, called the AGAMEMNON project, is looking into whether eating almonds can make a real difference for people who have both prediabetes and a condition called Non-Alcoholic Fatty Liver Disease (NAFLD). Prediabetes means your blood sugar levels are higher than normal, but not yet high enough to be classed as type 2 diabetes. NAFLD means there's too much fat stored in your liver, which can lead to more serious liver problems if not managed.

We know that healthy eating, like the Mediterranean diet, can help prevent heart disease and type 2 diabetes. Foods like almonds, which are part of this diet, are packed with good fats and fibre. This study wants to find out specifically how almonds might help improve various aspects of your health, such as controlling blood sugar, reducing liver fat, and affecting your overall body makeup and inflammation. Previous studies haven't fully shown these benefits, so this project aims to get a clearer picture.

The researchers will follow 150 adults for 16 weeks. Some will eat almonds daily, while others won't. They will carefully check things like blood sugar levels, how much fat is in the liver, and other health markers. The study is designed so that any changes seen are likely due to the almonds themselves, not just weight loss. This will help them understand the specific ways almonds might benefit your health.

Key takeaways

Study examines if almonds help with prediabetes and fatty liver disease.
Participation involves adding almonds to diet or maintaining usual diet for 16 weeks.
Measurements include blood sugar, liver fat, body shape, and inflammation.
Open to adults aged 35-70 with diagnosed prediabetes and NAFLD.
Aims to understand specific benefits of almonds on metabolic health.

Who may be eligible?

To be considered for this study, you would need to be between 35 and 70 years old. You must have been diagnosed with prediabetes, meaning your blood sugar levels are higher than normal but not yet full-blown diabetes. You also need to have Non-Alcoholic Fatty Liver Disease (NAFLD), which will be checked using a special scan. Your body mass index (BMI) should be between 25 and 40, meaning you are overweight or obese.

There are several reasons why you might not be able to join. For example, if you are currently taking medication for diabetes, have full-blown diabetes, or suffer from serious heart, lung, or kidney problems, you wouldn't be eligible. Conditions like severe mental health issues, a recent cancer diagnosis (within the last 5 years), or any liver disease other than NAFLD would also exclude you. You also can't be pregnant, allergic to almonds, or have certain metal implants in your body.

Additionally, if you smoke, drink too much alcohol, are currently trying to lose a lot of weight, or have recently finished another medical study, you wouldn't be able to take part. 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 35 and 70 years old?
Have you been told you have prediabetes?
Do you have Non-Alcoholic Fatty Liver Disease (NAFLD)?
Do you have a BMI between 25 and 40?
Are you NOT currently taking diabetes medication?
Are you NOT allergic to almonds?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be followed for a total of 16 weeks. You would be asked to either include a specific amount of raw whole almonds in your daily diet or continue your usual diet without adding almonds. The study is designed so that your overall calorie intake stays the same, regardless of whether you eat almonds or not. Throughout the 16 weeks, you would have several visits to the clinic where researchers will perform various assessments. These might include blood tests to check blood sugar and fats, body scans to measure liver fat and body composition, and other checks for inflammation and gut health. At the end of the study, there will be a final check-up. The exact number of visits and tests will be explained to you in detail if you decide to inquire about participation.

Potential risks and benefits

Participating in this study might offer potential benefits, such as gaining a better understanding of your own health conditions and potentially seeing improvements in your blood sugar or liver fat levels if almonds prove beneficial. It also helps contribute to medical knowledge that could benefit many others in the future. Potential risks are generally low, mainly related to blood tests or scans, or possibly minor digestive discomfort if you are sensitive to almonds. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Charite University Hospital Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is prediabetes?

Prediabetes means your blood sugar levels are higher than normal, but not high enough to be called type 2 diabetes. It's a warning sign.

What is NAFLD?

NAFLD stands for Non-Alcoholic Fatty Liver Disease, which means there's too much fat in your liver, not caused by heavy drinking.

How long does the study last?

The study involves a 16-week period where you will be asked to follow specific dietary instructions, with follow-up appointments.

Will I have to pay for the almonds?

No, if you are in the almond group, the almonds will be provided to you by the study.

Can I eat other nuts during the study?

Specific instructions on diet will be given. Generally, it's important to stick to the study's guidance to ensure accurate results.

How to find out more

Stefan Kabisch, Dr. med.

stefan.kabisch@charite.de 0049-30-450514 Official trial record

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