Skip to main content
OpenTrials
Completed

NCT Number: NCT02616471

Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sport

Copenhagen, Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-fat cheese

Dietary Supplement

Low-fat cheese

Dietary Supplement

No-cheese/carbohydrate

Dietary Supplement

Primary outcomes

  1. Changes in LDL cholesterol from baseline to post-intervention

    Time frame: week 1 and week 12

    fasting, mmol/l

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: Osterix

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 30, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.