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 range18 Years – 70 Years

SexALL

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

What they're measuring

Changes in LDL cholesterol from baseline to post-intervention

Timeframe: week 1 and week 12

Trial details

NCT IDNCT02616471

SponsorUniversity of Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05