Clinical trial NCT02616471: Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors
Official title: Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors in a Metabolically Vulnerable Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Cheese
Dairy
Saturated fat
Blood lipid concentrations
Lipoprotein particle size
Metabolic Syndrome
Insulin sensitivity
Blood glucose concentrations
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Dairy Research Foundation, Denmark
name: Dairy Research Institute
name: Dairy Farmers of Canada
name: Centre National Interprofessionel de l'Economie Laitière
name: Dairy Australia
name: Nederlandse Zuivel Organisatie
First posted: 2015-11-30
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes in LDL cholesterol from baseline to post-intervention
timeFrame: week 1 and week 12
Secondary outcomes:
measure: Blood lipid concentrations
timeFrame: week 1 and week 12
measure: Particle size
timeFrame: week 1 and week 12
measure: Anthropometry
timeFrame: 5 times during the 12-week intervention
measure: Blood pressure (BP)
timeFrame: 3 time during the 12-week intervention
measure: Insulin sensitivity
timeFrame: week 1 and week 12
measure: Inflammation
timeFrame: week 1 and week 12
measure: Postprandial markers of lipid metabolism
timeFrame: week 12
measure: Postprandial markers of glucose metabolism
timeFrame: week 12
measure: Postprandial appetite sensation (by VAS)
timeFrame: week 12
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sport
state: Frederiksberg
Study officials:
affiliation: Head of Department of Nutrition, Exercise and Sports
name: Arne Astrup, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.