Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors (NCT02616471) | Clinical Trial Compass
CompletedNot Applicable
Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors
Denmark168 participantsStarted 2014-02
Plain-language summary
The overall aim of the present research project is to examine whether consumption of high daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a study population of men and women with metabolic syndrome risk factors.
It will be explored whether high-fat and/or low-fat cheese consumption can be regarded healthy to consume for at-risk populations (assessed by within-group comparisons from baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to be recommended (assessed by between-group comparisons).
In addition, it will be assessed if cheese consumption affects women and men differently as suggested by observational data. The present research project will examine the health effects of cheese as a food product per se and not as a sum of single nutrients, knowing that the single components of cheese cannot be adequately placebo-matched. A relatively high daily intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a carbohydrate control.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Men or women
Age 18-70
Waist circumference \> 80 cm for women / \> 94 cm for men
Plus at least one additional established risk factor for the metabolic syndrome using the following criteria:
* Elevated BP (Systolic BP \> 130 mmHg and/or diastolic BP \> 85 mmHg);
* Elevated triglycerides (\>1.7 mmol/l);
* Reduced HDL-C (\<1.0 mmol/l for men and \< 1.3 mmol/l for women);
* Elevated fasting glucose (\> 5.6 mmol/l). BMI 18.5 - 35 kg/m2
Exclusion Criteria:
Chronic diseases (known diabetes; cardiovascular disease; other chronic diseases which could affect the results of the present study)
Milk allergy
Use of dietary supplements incl. multivitamins (2 months before and during the entire study period)
\>10 hours of strenuous physical activity per week
Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids or medicine which have interactions with the intervention products (safety)
Drug or alcohol abuse
Blood donation \<1 month before study commencement and during study period
Simultaneous participation in other clinical studies
Pregnant or lactating women, or women who are planning to become pregnant within the next 6 months.
Inability to comply with the procedures required by the protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in LDL cholesterol from baseline to post-intervention