Effect of Cheese on Cardiovascular Risk

Not Applicable

Completed

• Conditions: Hyperlipidemia

• Registration Number: NCT01739153
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-12-03
• Study Start: 2013-01
• Primary Completion: 2013-08
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
LDL cholesterol	day 1 and day 14 in each diet period	fasting, mmol/l

Secondary Outcome Measures

Name	Time	Method
Dietary fat digestibility	During day 10-14 in each period	Fecal fat and energy excretion.; Total excretion of fecal fat (grams/day) and energy (kJ/day) averaged over five days
Bile acid metabolism	day 14 of each intervention period	Serum alpha-HC, fecal bile acid excretion
Blood pressure	day 1 and day 14 in each diet period	mmHg
ApoA1 and ApoB	day 1 and day 14 in each diet period
Anthropometry	day 1 and day 14 in each diet period	waist to hip ratio, waist circumference and body weight
Blood lipid concentrations	day 1 and day 14 in each diet period	Total cholesterol and HDL cholesterol. Fasting, mmol/l.; Triglycerides. Fasting and non-fasting, mmol/l
Insulin sensitivity	day 1 and 14 in each diet period	Fasting and non-fasting glucose and insulin

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports; 🇩🇰 Copenhagen, Frederiksberg, Denmark