Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

Not Applicable

Completed

• Conditions: Metabolic Syndrome

• Registration Number: NCT02616471
• Lead Sponsor: University of Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-20
• Study Start: 2014-02
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in LDL cholesterol from baseline to post-intervention	week 1 and week 12	fasting, mmol/l

Secondary Outcome Measures

Name	Time	Method
Particle size	week 1 and week 12	HDL, VLDL and LDL particle size (by NMR)
Blood lipid concentrations	week 1 and week 12	Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l)
Anthropometry	5 times during the 12-week intervention	Hip circumference (cm) Waist circumference (cm) Weight (kg)
Blood pressure (BP)	3 time during the 12-week intervention	Systolic BP (mmHG) Diastolic BP (mmHG)
Insulin sensitivity	week 1 and week 12	Plasma glucose - fasting (mmol/l) Plasma insulin - fasting (mmol/l)
Inflammation	week 1 and week 12	Serum C-reactive protein - fasting (mmol/l)
Postprandial markers of lipid metabolism	week 12	Measurements in a sub-group
Postprandial markers of glucose metabolism	week 12	Measurements in a sub-group
Postprandial appetite sensation (by VAS)	week 12	Measurements in a sub-group

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sport; 🇩🇰 Copenhagen, Frederiksberg, Denmark