AzTrials
AzTrials

Metabolic SyndromeOsterixNCT02616471

Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors

A study testing High-fat cheese, Low-fat cheese and No-cheese/carbohydrate in people with Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The overall aim of the present research project is to examine whether consumption of high daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a study population of men and women with metabolic syndrome risk factors. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome
What is being tested?
High-fat cheese, Low-fat cheese and No-cheese/carbohydrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteDenmark
Study dates
Feb 2014to May 2015
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men or women
  • Age 18-70
  • Waist circumference > 80 cm for women / > 94 cm for men
  • Plus at least one additional established risk factor for the metabolic syndrome using the following criteria:
  • Elevated BP (Systolic BP > 130 mmHg and/or diastolic BP > 85 mmHg);
  • Elevated triglycerides (>1.7 mmol/l);
  • Reduced HDL-C (<1.0 mmol/l for men and < 1.3 mmol/l for women);
  • Elevated fasting glucose (> 5.6 mmol/l). BMI 18.5 - 35 kg/m2

Who cannot join

  • Chronic diseases (known diabetes; cardiovascular disease; other chronic diseases which could affect the results of the present study)
  • Milk allergy
  • Use of dietary supplements incl. multivitamins (2 months before and during the entire study period)
  • >10 hours of strenuous physical activity per week
  • Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids or medicine which have interactions with the intervention products (safety)
  • Drug or alcohol abuse
Show all 10Show fewer
  • Blood donation <1 month before study commencement and during study period
  • Simultaneous participation in other clinical studies
  • Pregnant or lactating women, or women who are planning to become pregnant within the next 6 months.
  • Inability 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 Sport

    Copenhagen, Frederiksberg, 1958

Other trials in Denmark

About this study

Official title: Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors in a Metabolically Vulnerable Population

The overall aim of the present research project is to examine whether consumption of high daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a study population of men and women with metabolic syndrome risk factors.

It will be explored whether high-fat and/or low-fat cheese consumption can be regarded healthy to consume for at-risk populations (assessed by within-group comparisons from baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to be recommended (assessed by between-group comparisons).

In addition, it will be assessed if cheese consumption affects women and men differently as suggested by observational data. The present research project will examine the health effects of cheese as a food product per se and not as a sum of single nutrients, knowing that the single components of cheese cannot be adequately placebo-matched. A relatively high daily intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a carbohydrate control.

Being tested
High-fat cheese, Low-fat cheese, No-cheese/carbohydrate
Keywords
Cheese, Dairy, Saturated fat, Blood lipid concentrations, Lipoprotein particle size, Metabolic Syndrome, Insulin sensitivity, Blood glucose concentrations
Medical subject headings
Metabolic Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-fat cheeseDietary supplement

  • Low-fat cheeseDietary supplement

  • No-cheese/carbohydrateDietary supplement

Study groups in NCT02616471
Study groupRoleWhat they receive
High-fat cheese (HFC) groupExperimentalThe subjects in the HFC group will be supplied with equal amounts of two types of regular/high fat cheeses. The cheeses are normal-fat Danbo (Riberhus, 25% fat, Arla, DK) and normal-fat Cheddar (Sharp Cheddar, 32% fat, Cabot, US). No further dairy and cheese consumption is allowed
Receives: Dietary Supplement: High-fat cheese
Low-fat cheese (LFC) groupExperimentalThe subjects in the LFC group will be supplied with equal amounts of two types of reduced/low fat cheeses. The cheeses are reduced-fat Danbo(Cheasy, 13% fat, Arla, DK) and reduced-fat Cheddar (Sharp Light Cheddar, 16% fat, Cabot, US). No further dairy/cheese consumption is allowed.
Receives: Dietary Supplement: Low-fat cheese
No-cheese/carbohydrate group (CTR)Active comparatorFor subjects in the CTR group, cheese is replaced by simple and starchy carbohydrates in jam and white bread, which will be supplied by the department. The daily energy and sodium contents will be matched to those of the cheese in the HFC group. No dairy/cheese consumption is allowed.
Receives: Dietary Supplement: No-cheese/carbohydrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in LDL cholesterol from baseline to post-intervention

    fasting, mmol/l

    Measured: week 1 and week 12

Secondary outcomes (9)

  1. Blood lipid concentrations

    Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l)

    Measured: week 1 and week 12

  2. Particle size

    HDL, VLDL and LDL particle size (by NMR)

    Measured: week 1 and week 12

  3. Anthropometry

    Hip circumference (cm) Waist circumference (cm) Weight (kg)

    Measured: 5 times during the 12-week intervention

  4. Blood pressure (BP)

    Systolic BP (mmHG) Diastolic BP (mmHG)

    Measured: 3 time during the 12-week intervention

  5. Insulin sensitivity

    Plasma glucose - fasting (mmol/l) Plasma insulin - fasting (mmol/l)

    Measured: week 1 and week 12

  6. Inflammation

    Serum C-reactive protein - fasting (mmol/l)

    Measured: week 1 and week 12

  7. Postprandial markers of lipid metabolism

    Measurements in a sub-group

    Measured: week 12

  8. Postprandial markers of glucose metabolism

    Measurements in a sub-group

    Measured: week 12

  9. Postprandial appetite sensation (by VAS)

    Measurements in a sub-group

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616471
Sponsor's protocol ID
B306
Acronym
Osterix
Status last verified
Aug 2018
First submitted
20 Jan 2014
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Raziani F, Tholstrup T, Kristensen MD, Svanegaard ML, Ritz C, Astrup A, Raben A. High intake of regular-fat cheese compared with reduced-fat cheese does not affect LDL cholesterol or risk markers of the metabolic syndrome: a randomized controlled trial. Am J Clin Nutr. 2016 Oct;104(4):973-981. doi: 10.3945/ajcn.116.134932. Epub 2016 Aug 24.

    PubMed 27557654

Questions about this trial

What is this clinical trial studying?

A study testing High-fat cheese, Low-fat cheese and No-cheese/carbohydrate in people with Metabolic Syndrome, 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 8 inclusion and 10 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 31 Aug 2018. 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?

Changes in LDL cholesterol from baseline to post-intervention (time frame: week 1 and week 12). 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 NCT02616471, 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 31 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in