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Completed

NCT Number: NCT01739153

Effect of Cheese on Cardiovascular Risk

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–68 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention: CHEESE (High cheese intake)

Other

Dietary intervention: MEAT (High Meat intake)

Other

Dietary intervention: CARB (High Carbohydrate intake)

Other

Primary outcomes

  1. LDL cholesterol

    Time frame: day 1 and day 14 in each diet period

    fasting, mmol/l

Secondary outcomes

  1. Blood lipid concentrations

    Time frame: day 1 and day 14 in each diet period

    Total cholesterol and HDL cholesterol. Fasting, mmol/l.

    Triglycerides. Fasting and non-fasting, mmol/l

  2. ApoA1 and ApoB

    Time frame: day 1 and day 14 in each diet period

  3. Dietary fat digestibility

    Time frame: 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

  4. Blood pressure

    Time frame: day 1 and day 14 in each diet period

    mmHg

  5. Anthropometry

    Time frame: day 1 and day 14 in each diet period

    waist to hip ratio, waist circumference and body weight

  6. Insulin sensitivity

    Time frame: day 1 and 14 in each diet period

    Fasting and non-fasting glucose and insulin

  7. Bile acid metabolism

    Time frame: day 14 of each intervention period

    Serum alpha-HC, fecal bile acid excretion

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • 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

Registry information

Acronym: ECCA

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 3, 2012
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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