HyperlipidemiaECCANCT01739153
Effect of Cheese on Cardiovascular Risk
A study testing Dietary intervention: CHEESE (High cheese intake), Dietary intervention: MEAT (High Meat intake) and Dietary intervention: CARB (High Carbohydrate intake) in people with Hyperlipidemia, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 45 to 68 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Dietary intervention: CHEESE (High cheese intake), Dietary intervention: MEAT (High Meat intake) and Dietary intervention: CARB (High Carbohydrate intake)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 68 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958
About this study
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.
- Conditions
- Hyperlipidemia
- Being tested
- Dietary intervention: CHEESE (High cheese intake), Dietary intervention: MEAT (High Meat intake), Dietary intervention: CARB (High Carbohydrate intake)
- Keywords
- Dairy, Cheese, Blood lipid concentrations, Blood lipid sizes, Fecal fat, Fat digestibility, bile acids
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention: CHEESE (High cheese intake)Other
Dietary intervention: MEAT (High Meat intake)Other
Dietary intervention: CARB (High Carbohydrate intake)Other
| Study group | Role | What they receive |
|---|---|---|
| CARB diet | Experimental | The CARB diet will be a low-fat diet where cheese is replaced by starchy carbohydrates and lean meat. The CARB diet will have the same protein content (15 E%) and quality as the CHEESE and MEAT diet but a lower fat content (approx. 25 E%) and a correspondingly higher carbohydrate content (approx. 60 E%). Receives: Other: Dietary intervention: CARB (High Carbohydrate intake) |
| CHEESE diet | Experimental | The CHEESE diet will contain cheese in amounts corresponding to 120 g/day on a 10 MJ diet (approx. 1.8 MJ from cheese). A high dose of cheese is chosen to provoke effects within this short time frame. The cheese types used in this study will be Danbo (45+) and Cheddar (50+) which will be supplied in equal amounts. The CHEESE diet will have the same macronutrient composition as that of the average Danish diet (15 E% from protein, max 35 E% from fat, and max 15 E% from saturated fat). Receives: Other: Dietary intervention: CHEESE (High cheese intake) |
| MEAT diet | Experimental | The MEAT diet will be a diet without dairy products. In this diet cheese is mainly replaced by high-fat mixed meat products to achieve saturated fat content and protein quality similar to that of the CHEESE diet. The MEAT diet will have the same macronutrient composition as that of the average Danish diet (15 E% from protein, max 35 E% from fat, and max 15 E% from saturated fat). Receives: Other: Dietary intervention: MEAT (High Meat intake) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
fasting, mmol/l
Measured: day 1 and day 14 in each diet period
Secondary outcomes (7)
Blood lipid concentrations
Total cholesterol and HDL cholesterol. Fasting, mmol/l.
Triglycerides. Fasting and non-fasting, mmol/l
Measured: day 1 and day 14 in each diet period
ApoA1 and ApoB
Measured: day 1 and day 14 in each diet period
Dietary fat digestibility
Fecal fat and energy excretion.
Total excretion of fecal fat (grams/day) and energy (kJ/day) averaged over five days
Measured: During day 10-14 in each period
Blood pressure
mmHg
Measured: day 1 and day 14 in each diet period
Anthropometry
waist to hip ratio, waist circumference and body weight
Measured: day 1 and day 14 in each diet period
Insulin sensitivity
Fasting and non-fasting glucose and insulin
Measured: day 1 and 14 in each diet period
Bile acid metabolism
Serum alpha-HC, fecal bile acid excretion
Measured: day 14 of each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, Dairy Research Institute, Dairy Farmers of Canada, Centre National Interprofessionel de l'Economie Laitière, Dairy Australia, Nederlandse Zuivel Organisatie
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Prof, MD, Principal investigator, Head of Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739153
- Sponsor's protocol ID
- B302
- Acronym
- ECCA
- Status last verified
- Nov 2014
- First submitted
- 27 Nov 2012
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26178720
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cheese on Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT01739153
- Acronym / sponsor ID
- ECCA / B302
- Conditions
- Hyperlipidemia
- Keywords
- Dairy, Cheese, Blood lipid concentrations, Blood lipid sizes, Fecal fat, Fat digestibility, bile acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Dairy Research Foundation, Denmark, Dairy Research Institute, Dairy Farmers of Canada, Centre National Interprofessionel de l'Economie Laitière, Dairy Australia, Nederlandse Zuivel Organisatie
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CARB diet | Experimental | Other: Dietary intervention: CARB (High Carbohydrate intake)The CARB diet will be a low-fat diet where cheese is replaced by starchy carbohydrates and lean meat. The CARB diet will have the same protein content (15 E%) and quality as the CHEESE and MEAT diet but a lower fat content (approx. 25 E%) and a correspondingly higher carbohydrate content (approx. 60 E%). |
| CHEESE diet | Experimental | Other: Dietary intervention: CHEESE (High cheese intake)The CHEESE diet will contain cheese in amounts corresponding to 120 g/day on a 10 MJ diet (approx. 1.8 MJ from cheese). A high dose of cheese is chosen to provoke effects within this short time frame. The cheese types used in this study will be Danbo (45+) and Cheddar (50+) which will be supplied in equal amounts. The CHEESE diet will have the same macronutrient composition as that of the average Danish diet (15 E% from protein, max 35 E% from fat, and max 15 E% from saturated fat). |
| MEAT diet | Experimental | Other: Dietary intervention: MEAT (High Meat intake)The MEAT diet will be a diet without dairy products. In this diet cheese is mainly replaced by high-fat mixed meat products to achieve saturated fat content and protein quality similar to that of the CHEESE diet. The MEAT diet will have the same macronutrient composition as that of the average Danish diet (15 E% from protein, max 35 E% from fat, and max 15 E% from saturated fat). |
Who may qualify
- Ages
- 45 to 68 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female gender
- Postmenopausal for >1 year
- Age 45-68 years
- BMI 25-32 kg/m2
- TC > 4.5 mmol/L and < 7 mmol/L
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention: CHEESE (High cheese intake) | Other | CHEESE diet |
| Dietary intervention: MEAT (High Meat intake) | Other | MEAT diet |
| Dietary intervention: CARB (High Carbohydrate intake) | Other | CARB diet |
Primary outcome
LDL cholesterol
Time frame: day 1 and day 14 in each diet period
fasting, mmol/l
7 secondary outcomes
Blood lipid concentrations
Time frame: day 1 and day 14 in each diet period
ApoA1 and ApoB
Time frame: day 1 and day 14 in each diet period
Dietary fat digestibility
Time frame: During day 10-14 in each period
Blood pressure
Time frame: day 1 and day 14 in each diet period
Anthropometry
Time frame: day 1 and day 14 in each diet period
Insulin sensitivity
Time frame: day 1 and 14 in each diet period
Bile acid metabolism
Time frame: day 14 of each intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Derived from this study: PubMed 26178720Thorning 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Prof, MD principal investigator
Head of Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention: CHEESE (High cheese intake), Dietary intervention: MEAT (High Meat intake) and Dietary intervention: CARB (High Carbohydrate intake) in people with Hyperlipidemia, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL cholesterol (time frame: day 1 and day 14 in each diet period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.