Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

NCT ID: NCT02616471

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-05-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

High-fat cheese

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: EXPERIMENTAL

Low-fat cheese

Intervention Type: DIETARY_SUPPLEMENT

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.

Group Type: ACTIVE_COMPARATOR

No-cheese/carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

Interventions

High-fat cheese

Intervention Type: DIETARY_SUPPLEMENT

Low-fat cheese

Intervention Type: DIETARY_SUPPLEMENT

No-cheese/carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Danish Dairy Research Foundation, Denmark

OTHER

Sponsor Role: collaborator

Dairy Research Institute

OTHER

Sponsor Role: collaborator

Dairy Farmers of Canada

OTHER

Sponsor Role: collaborator

Centre National Interprofessionel de l'Economie Laitière

OTHER

Sponsor Role: collaborator

Dairy Australia

INDUSTRY

Sponsor Role: collaborator

Nederlandse Zuivel Organisatie

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Arne Astrup

Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arne Astrup, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Department of Nutrition, Exercise and Sports

Locations

Department of Nutrition, Exercise and Sport

Copenhagen, Frederiksberg, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 27557654 (View on PubMed)

Other Identifiers

B306

Identifier Type: -

Identifier Source: org_study_id