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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

High-fat cheese

Low-fat cheese

No-cheese/carbohydrate

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Cheese, Dairy, Saturated fat, Blood lipid concentrations, Lipoprotein particle size, Metabolic Syndrome, Insulin sensitivity, Blood glucose concentrations

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Nutrition, Exercise and Sport

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

High-fat cheese (HFC) group

Low-fat cheese (LFC) group

No-cheese/carbohydrate group (CTR)

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Changes in LDL cholesterol from baseline to post-intervention

fasting, mmol/l

Secondary Outcome Measures

Blood lipid concentrations

Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l)

Particle size

HDL, VLDL and LDL particle size (by NMR)

Anthropometry

Hip circumference (cm) Waist circumference (cm) Weight (kg)

Blood pressure (BP)

Systolic BP (mmHG) Diastolic BP (mmHG)

Insulin sensitivity

Plasma glucose - fasting (mmol/l) Plasma insulin - fasting (mmol/l)

Inflammation

Serum C-reactive protein - fasting (mmol/l)

Postprandial markers of lipid metabolism

Measurements in a sub-group

Postprandial markers of glucose metabolism

Measurements in a sub-group

Postprandial appetite sensation (by VAS)

Measurements in a sub-group

Full Information

NCT ID

NCT02616471

First Posted

January 20, 2014

Last Updated

August 28, 2018

Sponsor

University of Copenhagen

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

1. Study Identification

Unique Protocol Identification Number

NCT02616471

Brief Title

Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

Acronym

Osterix

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Copenhagen

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

Cheese, Dairy, Saturated fat, Blood lipid concentrations, Lipoprotein particle size, Metabolic Syndrome, Insulin sensitivity, Blood glucose concentrations

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-fat cheese (HFC) group

Arm Type

Experimental

Arm Description

Arm Title

Low-fat cheese (LFC) group

Arm Type

Experimental

Arm Description

Arm Title

No-cheese/carbohydrate group (CTR)

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

High-fat cheese

Intervention Type

Dietary Supplement

Intervention Name(s)

Low-fat cheese

Intervention Type

Dietary Supplement

Intervention Name(s)

No-cheese/carbohydrate

Primary Outcome Measure Information:

Title

Changes in LDL cholesterol from baseline to post-intervention

Description

fasting, mmol/l

Time Frame

week 1 and week 12

Secondary Outcome Measure Information:

Title

Blood lipid concentrations

Description

Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l)

Time Frame

week 1 and week 12

Title

Particle size

Description

HDL, VLDL and LDL particle size (by NMR)

Time Frame

week 1 and week 12

Title

Anthropometry

Description

Hip circumference (cm) Waist circumference (cm) Weight (kg)

Time Frame

5 times during the 12-week intervention

Title

Blood pressure (BP)

Description

Systolic BP (mmHG) Diastolic BP (mmHG)

Time Frame

3 time during the 12-week intervention

Title

Insulin sensitivity

Description

Plasma glucose - fasting (mmol/l) Plasma insulin - fasting (mmol/l)

Time Frame

week 1 and week 12

Title

Inflammation

Description

Serum C-reactive protein - fasting (mmol/l)

Time Frame

week 1 and week 12

Title

Postprandial markers of lipid metabolism

Description

Measurements in a sub-group

Time Frame

week 12

Title

Postprandial markers of glucose metabolism

Description

Measurements in a sub-group

Time Frame

week 12

Title

Postprandial appetite sensation (by VAS)

Description

Measurements in a sub-group

Time Frame

week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arne Astrup, Prof, MD

Organizational Affiliation

Head of Department of Nutrition, Exercise and Sports

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nutrition, Exercise and Sport

City

Copenhagen

State/Province

Frederiksberg

ZIP/Postal Code

1958

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

27557654

Citation

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.

Results Reference

derived

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Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

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