Effect of Cheese on Cardiovascular Risk

Hyperlipidemia Clinical Trial

— ECCA  

Official title:

Effect of Cheese on Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739153
• Other study ID #: B302
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: November 20, 2014
• Start date: January 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 68 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Other:
• Dietary intervention: CHEESE (High cheese intake)

• Dietary intervention: MEAT (High Meat intake)

• Dietary intervention: CARB (High Carbohydrate intake)

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen	Frederiksberg

Sponsors (7)

Lead Sponsor	Collaborator
University of Copenhagen	Centre National Interprofessionel de l'Economie Laitière, Dairy Australia, Dairy Farmers of Canada, Dairy Research Institute, Nederlandse Zuivel Organisatie, The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol	fasting, mmol/l	day 1 and day 14 in each diet period	No
Secondary	Blood lipid concentrations	Total cholesterol and HDL cholesterol. Fasting, mmol/l.; Triglycerides. Fasting and non-fasting, mmol/l	day 1 and day 14 in each diet period	No
Secondary	ApoA1 and ApoB		day 1 and day 14 in each diet period	No
Secondary	Dietary fat digestibility	Fecal fat and energy excretion.; Total excretion of fecal fat (grams/day) and energy (kJ/day) averaged over five days	During day 10-14 in each period	No
Secondary	Blood pressure	mmHg	day 1 and day 14 in each diet period	No
Secondary	Anthropometry	waist to hip ratio, waist circumference and body weight	day 1 and day 14 in each diet period	No
Secondary	Insulin sensitivity	Fasting and non-fasting glucose and insulin	day 1 and 14 in each diet period	No
Secondary	Bile acid metabolism	Serum alpha-HC, fecal bile acid excretion	day 14 of each intervention period	No