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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: High-fat cheese; Dietary supplement: Low-fat cheese; Dietary supplement: No-cheese/carbohydrate

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg
    • Copenhagen, Frederiksberg, Denmark, 1958
      • Department of Nutrition, Exercise and Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in LDL cholesterol from baseline to post-intervention	fasting, mmol/l	week 1 and week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Dairy Farmers of Canada; The Danish Dairy Research Foundation, Denmark; Dairy Research Institute; 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 and helpful links

General Publications

• Raziani F, Tholstrup T, Kristensen MD, Svanegaard ML, Ritz C, Astrup A, Raben A. High intake of regular-fat cheese compared with reduced-fat cheese does not affect LDL cholesterol or risk markers of the metabolic syndrome: a randomized controlled trial. Am J Clin Nutr. 2016 Oct;104(4):973-981. doi: 10.3945/ajcn.116.134932. Epub 2016 Aug 24.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 30, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; Dairy; Cheese; Saturated fat; Blood lipid concentrations; Lipoprotein particle size; Insulin sensitivity; Blood glucose concentrations
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: B306

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No