Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors (Osterix)
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|ClinicalTrials.gov Identifier: NCT02616471|
Recruitment Status : Completed
First Posted : November 30, 2015
Last Update Posted : August 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Dietary Supplement: High-fat cheese Dietary Supplement: Low-fat cheese Dietary Supplement: No-cheese/carbohydrate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors in a Metabolically Vulnerable Population|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: High-fat cheese (HFC) group
The 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
Dietary Supplement: High-fat cheese
Experimental: Low-fat cheese (LFC) group
The 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.
Dietary Supplement: Low-fat cheese
Active Comparator: No-cheese/carbohydrate group (CTR)
For 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.
Dietary Supplement: No-cheese/carbohydrate
- Changes in LDL cholesterol from baseline to post-intervention [ Time Frame: week 1 and week 12 ]fasting, mmol/l
- Blood lipid concentrations [ Time Frame: week 1 and week 12 ]Total and HDL cholesterol - fasting (mmol/l) Triglycerides - fasting (mmol/l)
- Particle size [ Time Frame: week 1 and week 12 ]HDL, VLDL and LDL particle size (by NMR)
- Anthropometry [ Time Frame: 5 times during the 12-week intervention ]Hip circumference (cm) Waist circumference (cm) Weight (kg)
- Blood pressure (BP) [ Time Frame: 3 time during the 12-week intervention ]Systolic BP (mmHG) Diastolic BP (mmHG)
- Insulin sensitivity [ Time Frame: week 1 and week 12 ]Plasma glucose - fasting (mmol/l) Plasma insulin - fasting (mmol/l)
- Inflammation [ Time Frame: week 1 and week 12 ]Serum C-reactive protein - fasting (mmol/l)
- Postprandial markers of lipid metabolism [ Time Frame: week 12 ]Measurements in a sub-group
- Postprandial markers of glucose metabolism [ Time Frame: week 12 ]Measurements in a sub-group
- Postprandial appetite sensation (by VAS) [ Time Frame: week 12 ]Measurements in a sub-group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616471
|Department of Nutrition, Exercise and Sport|
|Copenhagen, Frederiksberg, Denmark, 1958|
|Principal Investigator:||Arne Astrup, Prof, MD||Head of Department of Nutrition, Exercise and Sports|