Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

Metabolic Syndrome Clinical Trial

— Osterix  

Official title:

Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors in a Metabolically Vulnerable Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616471
• Other study ID #: B306
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• High-fat cheese

• Low-fat cheese

• No-cheese/carbohydrate

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sport	Copenhagen	Frederiksberg

Sponsors (7)

Lead Sponsor	Collaborator
University of Copenhagen	Centre National Interprofessionel de l'Economie Laitière, Dairy Australia, Dairy Farmers of Canada, Dairy Research Institute, Nederlandse Zuivel Organisatie, The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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