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Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors (Osterix)

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ClinicalTrials.gov Identifier: NCT02616471
Recruitment Status : Completed
First Posted : November 30, 2015
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
The Danish Dairy Research Foundation, Denmark
Dairy Research Institute
Dairy Farmers of Canada
Centre National Interprofessionel de l'Economie Laitière
Dairy Australia
Nederlandse Zuivel Organisatie
Information provided by (Responsible Party):
Arne Astrup, 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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: High-fat cheese Dietary Supplement: Low-fat cheese Dietary Supplement: No-cheese/carbohydrate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors in a Metabolically Vulnerable Population
Actual Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-fat cheese (HFC) group

The subjects in the HFC group will be supplied with equal amounts of two types of regular/high fat cheeses. The cheeses are normal-fat Danbo (Riberhus, 25% fat, Arla, DK) and normal-fat Cheddar (Sharp Cheddar, 32% fat, Cabot, US).

No further dairy and cheese consumption is allowed

Dietary Supplement: High-fat cheese
Experimental: Low-fat cheese (LFC) group
The subjects in the LFC group will be supplied with equal amounts of two types of reduced/low fat cheeses. The cheeses are reduced-fat Danbo(Cheasy, 13% fat, Arla, DK) and reduced-fat Cheddar (Sharp Light Cheddar, 16% fat, Cabot, US). No further dairy/cheese consumption is allowed.
Dietary Supplement: Low-fat cheese
Active Comparator: No-cheese/carbohydrate group (CTR)
For subjects in the CTR group, cheese is replaced by simple and starchy carbohydrates in jam and white bread, which will be supplied by the department. The daily energy and sodium contents will be matched to those of the cheese in the HFC group. No dairy/cheese consumption is allowed.
Dietary Supplement: No-cheese/carbohydrate



Primary Outcome Measures :
  1. Changes in LDL cholesterol from baseline to post-intervention [ Time Frame: week 1 and week 12 ]
    fasting, mmol/l


Secondary Outcome Measures :
  1. Blood lipid concentrations [ Time Frame: week 1 and week 12 ]
    Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l)

  2. Particle size [ Time Frame: week 1 and week 12 ]
    HDL, VLDL and LDL particle size (by NMR)

  3. Anthropometry [ Time Frame: 5 times during the 12-week intervention ]
    Hip circumference (cm) Waist circumference (cm) Weight (kg)

  4. Blood pressure (BP) [ Time Frame: 3 time during the 12-week intervention ]
    Systolic BP (mmHG) Diastolic BP (mmHG)

  5. Insulin sensitivity [ Time Frame: week 1 and week 12 ]
    Plasma glucose - fasting (mmol/l) Plasma insulin - fasting (mmol/l)

  6. Inflammation [ Time Frame: week 1 and week 12 ]
    Serum C-reactive protein - fasting (mmol/l)

  7. Postprandial markers of lipid metabolism [ Time Frame: week 12 ]
    Measurements in a sub-group

  8. Postprandial markers of glucose metabolism [ Time Frame: week 12 ]
    Measurements in a sub-group

  9. Postprandial appetite sensation (by VAS) [ Time Frame: week 12 ]
    Measurements in a sub-group



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616471


Locations
Denmark
Department of Nutrition, Exercise and Sport
Copenhagen, Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Danish Dairy Research Foundation, Denmark
Dairy Research Institute
Dairy Farmers of Canada
Centre National Interprofessionel de l'Economie Laitière
Dairy Australia
Nederlandse Zuivel Organisatie
Investigators
Principal Investigator: Arne Astrup, Prof, MD Head of Department of Nutrition, Exercise and Sports

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arne Astrup, Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02616471     History of Changes
Other Study ID Numbers: B306
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Arne Astrup, University of Copenhagen:
Cheese
Dairy
Saturated fat
Blood lipid concentrations
Lipoprotein particle size
Metabolic Syndrome
Insulin sensitivity
Blood glucose concentrations

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases