Clinical trial NCT01739153: Effect of Cheese on Cardiovascular Risk
Official title: Effect of Cheese on Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Keywords: Dairy
Cheese
Blood lipid concentrations
Blood lipid sizes
Fecal fat
Fat digestibility
bile acids
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: 2012-12-03
Enrollment: 19
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The main objective of the current study is to examine whether a high intake of regular-fat cheeses (Danbo and Cheddar) affect blood lipids differently than an isocaloric intake of either other fatty animal food products or of starchy carbohydrates. Furthermore, effects on fat digestibility, blood pressure, anthropometry, bile acid metabolism and insulin sensitivity is investigated.

To do this, a randomized crossover intervention study with 3x14 days full diet periods (cheese diet, meat diet or carb diet)will be conducted in 16 postmenopausal women. Between the diet periods there will be at least 14 days of wash-out where the subjects eat their habitual diets. Fasting blood samples will be drawn before and after the diet periods, and also a non-fasting blood sample will be drawn after the diet periods. Furthermore, total feces is collected the last 5 days of each diet period.


Eligibility criteria: Inclusion Criteria:

* Female gender
* Postmenopausal for \>1 year
* Age 45-68 years
* BMI 25-32 kg/m2
* TC \> 4.5 mmol/L and \< 7 mmol/L
* Systolic blood pressure \<160 mmHg and/or diastolic blood pressure \<100 mmHg

Exclusion Criteria:

* Chronic diseases (known diabetes; CVD; other chronic diseases which could affect the results of the present study)
* Milk allergy
* Nut allergy
* Use of dietary supplements incl. multivitamins (2 months before and during the entire study period)
* Smoking
* Elite athletes (\>10 hours of strenuous physical activity per week)
* Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids
* Use of lipid-lowering agents
* Stable dose of antihypertensive medication \>3 months before study commencement for subjects with high blood pressure
* Hormone replacement therapy
* Blood donation \<1 month before study commencement and during study period
* Simultaneous participation in other clinical studies
* Inability (physically or psychologically) to comply with the procedures required by the protocol

Primary outcomes:
measure: LDL cholesterol
timeFrame: day 1 and day 14 in each diet period
Secondary outcomes:
measure: Blood lipid concentrations
timeFrame: day 1 and day 14 in each diet period
measure: ApoA1 and ApoB
timeFrame: day 1 and day 14 in each diet period
measure: Dietary fat digestibility
timeFrame: During day 10-14 in each period
measure: Blood pressure
timeFrame: day 1 and day 14 in each diet period
measure: Anthropometry
timeFrame: day 1 and day 14 in each diet period
measure: Insulin sensitivity
timeFrame: day 1 and 14 in each diet period
measure: Bile acid metabolism
timeFrame: day 14 of each intervention period
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
state: Frederiksberg
Study officials:
affiliation: Head of Department of Nutrition, Exercise and Sports
name: Arne Astrup, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorning TK, Raziani F, Bendsen NT, Astrup A, Tholstrup T, Raben A. Diets with high-fat cheese, high-fat meat, or carbohydrate on cardiovascular risk markers in overweight postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2015 Sep;102(3):573-81. doi: 10.3945/ajcn.115.109116. Epub 2015 Jul 15.