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The Miracle study: Research on how daily fat intake from different sources for 4 weeks affects our immune system.

The MIRACLE study: Modulating Immune Responses After Consistent Lipid Exposure - The MIRACLE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58006
Enrollment
39
Registered
2025-03-24
Start date
2025-11-28
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fat induced postprandial inflammation

Interventions

The dietary lipid challenge tests will be provided in the form of a liquid shake (0.6 L). Each shake will contain 95 gram of fat. The two types of fat that will be tested include: a) 100% plant-derive
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Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 dayHaving a mobile phone suitable for installing the research app Signed informed consent and able to adhere to the protocol

Exclusion criteria

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 dietInability 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. 

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to establish the impact of daily repetitive (T1) exposure to lipids from the same lipid source on the postprandial immune response reflected by IL-6 levels, compared to the effects of acute exposure (T0) using two different lipid sources (i.e. plant-derived and dairy-derived). Therefore we will determine postprandial IL-6 levels in the circulation as part of an ELISA multiplex assay after a high fat shake at T0 and T1. By measuring t=0 and all other sampling time points postprandially we will be able to determine protein dynamics and iAUCs of these cytokines. 

Secondary

MeasureTime frame
Secondary objectives are to:1) Compare postprandial IL-6 iAUC values at T0, T1, and T2, as defined by a multiplex ELISA assay2) Compare postprandial iAUC IL-6 values at T0, T1, and T2 between the plant-derived-fat and dairy-derived-fat, as defined by a multiplex ELISA assay3) Identify mechanisms underlying the immunomodulatory effect on PBMCs of different lipids at T0 as well as T1 and T2 after intake of lipids from the two fat sources. Using different readouts to define immune cell functioning, immune cell phenotypes, and circulating inflammatory parameters.4) Explore the effect of intake from the same lipid source on postprandial metabolic markers such as glucose and triglyceride levels, comparing levels at T0 with T1 and T2. Glucose will be measured through continuous glucose monitors, other metabolic markers will be measured in plasma 5) Assess the relationship between body composition (Dual Energy Xray absorptiometry [DXA] scan) and postprandial immunological responses, investigating T0, T1 and T2. 

Countries

Netherlands

Contacts

Public ContactR. Stienstra

Wageningen Universiteit

rinke.stienstra@wur.nl+31317482338

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026