Modulating immune responses after regular fat exposure

The MIRACLE Study: Modulating Immune Responses After Consistent Lipid Exposure

This project will see if daily dairy-based versus plant-based breakfast shakes change immune and inflammatory responses after repeated fat exposure in generally healthy adults aged 40–70.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: Wageningen University (other)
• Locations: 1 site (Wageningen)
• Trial ID: NCT07502898 on ClinicalTrials.gov

What this trial studies

Participants will consume a prescribed dairy-derived or plant-derived breakfast shake daily while researchers measure markers of postprandial inflammation and immune activation. Repeated blood sampling, including catheter-based draws, will be used to track triglycerides, circulating lipopolysaccharide and inflammatory mediators (for example IL-6, TNFα, VCAM1, ICAM1) and changes in gene expression in peripheral blood mononuclear cells. The protocol targets generally healthy middle-aged adults with BMI 22–27 and excludes people with diabetes, known cardiovascular disease, major GI disorders, recent antibiotic use, or relevant food allergies. Data will be used to compare the inflammatory impact of sustained dietary fat exposure from dairy versus plant sources.

Who should consider this trial

Good fit: Ideal candidates are generally healthy men or women aged 40–70 with BMI 22–27, suitable veins for blood sampling, no diabetes or major cardiovascular or gastrointestinal disease, and willingness to consume the assigned breakfast shake daily and use a study mobile app.

Not a fit: People with diabetes, prior cardiovascular events, major digestive diseases, recent antibiotic use, relevant food allergies/intolerances, or those outside the specified age and BMI ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could inform dietary recommendations to reduce chronic postprandial inflammation and long-term risk of metabolic and cardiovascular disease.

How similar studies have performed: Previous single-meal studies have shown that high-fat meals can raise postprandial inflammation, but longer-term comparisons of daily dairy versus plant fat exposure are limited and results to date are mixed.

Eligibility criteria

Inclusion Criteria:

* Apparently healthy man or woman
* Age 40-70y at the time of screening
* BMI of 22-27 kg/m2
* Having a Hb value above 8.4 (men) or 7.4 (women) mmol/L
* Having veins suitable for blood sampling via a catheter cannula (judged by study nurse/ medical doctor)
* Willing to have dairy-based breakfast every day
* Having a mobile phone suitable for installing the research app
* Signed informed consent and able to adhere to the protocol

Exclusion Criteria:

* A history of cardiovascular diseases, such as a stroke or heart disease;
* Having an eating disorder;
* Having diabetes (type I or type II);
* Having used antibiotics in the past 3 months;
* Using diabetes medication;
* Using medications that may affect the study results (as assessed by the study physician);
* Suffering from stomach or intestinal problems, such as Crohn's disease, ulcerative colitis, irritable bowel syndrome, or having undergone major digestive system surgery;
* Having known food allergies or intolerances to foods used in the study (e.g., cow's milk);
* Having an Hb level of less than 8.5 mmol/L (for men) or less than 7.5 mmol/L (for women) - to be tested during the eligibility assessment;
* Being allergic or intolerant to medical skin patches;
* Suffering from chronic or acute inflammatory diseases, such as rheumatoid arthritis or psoriatic arthritis;
* Having an autoimmune disease;
* Having thyroid problems;
* Having recently donated blood (within 2 months before the eligibility assessment) or planning to donate blood during the study period;
* Having recently participated in another medical-scientific study (within 2 months before the eligibility assessment);
* Suffering from severe kidney or liver problems or a chronic kidney or liver disease;
* Following a specific diet that may affect the results or is unsuitable for the study, such as a vegan diet;
* Using tobacco/drugs or smoking (including snus and/or vaping);
* Drinking more than 14 (for women) or 21 (for men) alcoholic drinks per week;
* Being pregnant, planning to become pregnant, or breastfeeding;
* Gained or lost more than 5 kg body weight in the past 3 months;
* Intention to lose or gain more than 5 kg during the study period;
* Intention to change exercise intensity during the study period;
* Not having a mobile phone suitable for using a research application;
* Having another serious medical condition that may interfere with participation, thus being deemed unsuitable for participation in the study as assessed by the study physician or principal investigator (e.g., displaying inappropriate behavior);
* Inability to comply with the study diet
* Inability to understand study information/communicate with staff;
* Being employed or doing an internship at the Department of Human Nutrition and Health of Wageningen University or FrieslandCampina.

Where this trial is running

Wageningen

• Wageningen University — Wageningen, Netherlands (RECRUITING)

Conditions: Lipid Metabolism, Postprandial Inflammation