RecruitingNAINTERVENTIONAL

Dairy Lipids and Cardiometabolic Risk

This research study is for adults living with severe obesity. We want to understand if eating different kinds of dairy products can help improve certain markers in your blood related to heart health, specifically something called apolipoprotein B. Participants will be split into groups and asked to include either low-fat dairy, regular whole-fat dairy, or whole-fat dairy with extra special fats from milk in their diet for three months. All of this will be part of a weight loss plan. Before and after the three months, we'll check your blood, both when you haven't eaten (fasting) and after you've had a standard meal, to see if there are any changes. This will help us learn more about how dairy might impact heart health in this group.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

28 Jun 2023

Estimated completion

01 Oct 2026

Morbid Obesity

What is this study about?

This study is about understanding how different types of dairy products can affect your heart health, especially if you have severe obesity. We know that certain blood fats can be important for your heart, and this study focuses on one called apolipoprotein B. The researchers want to see if changing the type of dairy you eat can help lower this particular blood fat.

Participants will be asked to include certain dairy products in their daily diet for three months, as part of a plan to help with weight loss. There will be three groups: one will have low-fat dairy, another will have regular whole-fat dairy, and the third will have whole-fat dairy that has been enriched with special fats found in milk. By comparing these groups, we hope to find out if whole-fat dairy, especially with these added special fats, might be more helpful in reducing apolipoprotein B than low-fat dairy.

Throughout the study, we'll be carefully checking your blood and other health measurements, both before you start and after the three months. This will help us track any changes in your body and understand the effects of the different dairy products. The aim is to get a clearer picture of how dairy choices can play a role in managing heart health for people with severe obesity.

Key takeaways

The study investigates how different dairy products affect heart health markers in adults with severe obesity.
It lasts for three months and involves a weight loss plan.
Participants will consume either low-fat, whole-fat, or special enriched whole-fat dairy.
Blood tests will be done before and after the study to check for changes.
Your involvement helps researchers learn more about diet and heart health.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old with a Body Mass Index (BMI) that shows you have severe obesity (between 35 and 60). You should also have had a stable weight for the past three months (not changing by more than 5%) and currently eat at least one serving of cow's milk dairy every day. You'll also need to agree to take part by giving your informed consent.

However, there are several reasons why you might not be able to join. For example, if you've had certain surgeries like weight loss surgery, or if you have digestive problems that might affect the study results. You also can't take part if you drink more than three glasses of alcohol a day, are pregnant, breastfeeding, or have allergies to dairy.

Additionally, if you are vegetarian, follow a very high protein diet, use certain dietary supplements, or are taking medications for cholesterol (like statins) or certain other conditions (like diabetes or some heart conditions), you would not be eligible. Anyone who has recently had antibiotics that affect gut bacteria, uses laxatives, or smokes 5 or more cigarettes a day would also not be able to join. These rules help make sure the study results are clear and reliable.

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 70 years old?
Do you have severe obesity (BMI between 35 and 60)?
Have you been eating cow's milk dairy at least once a day?
Are you able to commit to a 3-month study period?
Are you not currently pregnant or breastfeeding?
Are you currently not taking certain medications for cholesterol or diabetes?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for three months. You'll be asked to include a specific type of dairy product (low-fat, whole-fat, or special whole-fat enriched dairy) in your daily diet as part of a weight loss plan. Before the study starts and at the end of the three months, you'll have several assessments. These will include blood tests, both when you haven't eaten (fasting) and after you've had a standard meal provided by the study. These tests will help us measure various health markers. You won't need to take any specific medication from the study, but your current medications will be reviewed to ensure they don't interfere with the study's goals. There will be no long-term follow-up after the three-month intervention.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you'll receive guidance as part of a weight loss plan and contribute to scientific understanding that could help improve heart health for people with severe obesity. There are no major expected risks, but you will need to have blood tests, which carry small risks like bruising or discomfort. The dairy products provided are regular foods, but if you experience any unexpected reactions, you should inform the study team immediately. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

Centre de Recherche en Nutrition Humaine Rhône-Alpes
Verified postcode
Pierre-Bénite, France· Active not recruiting
Centres Hospitalier Lyon Sud, Service d'Endocrinologie-Diabète-Nutrition
Verified postcode
Pierre-Bénite, France· Recruiting

Common questions

What is 'apolipoprotein B'?

It's a type of protein in your blood that helps carry fats. High levels can sometimes indicate a higher risk for heart problems.

Why is 'severe obesity' the focus?

People with severe obesity often have a higher risk of heart-related problems, so understanding how diet impacts their health is important.

Will I know which dairy product I'm eating?

No, this is a 'blinded' study, meaning you won't know which specific type of dairy product you've been given until after the study is over. This helps keep the results fair.

Do I need to follow a special diet?

You'll be part of a weight loss plan and asked to include specific dairy products. Other dietary advice will be provided to help you with the weight loss goal.

How many times will I visit the study clinic?

You'll likely have a screening visit, an initial assessment visit, and a final assessment visit after three months. The exact number will be confirmed by the study team.

How to find out more

Emmanuel DISSE, Pr

emmanuel.disse@chu-lyon.fr +33 4 78 86 14 89 Official trial record

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