Dairy Products and Metabolic Effects (Norwegian Part)

Inclusion criteria

Apparently healthy men and women aged 30-65 years with:

• BMI < 35 kg/m2.
• Having signed a written informed consent
• Limited habitual intake of dairy products according to dietary questionnaire.
• Traits of the metabolic syndrome - two or more of the following criteria fulfilled:

• Fasting plasma glucose ≥ 6.1 mmol/l
• Serum triglycerides ≥ 1.7 mmol/l
• Serum HDL cholesterol < 1.0 mmol/l (40 mg/dl) (men) and < 1.3 mmol/l (50 mg/dl) (women)
• Blood pressure ≥130/ 85 mmHg
• Waist circumference >94cm (men) and >88cm (women).

Exclusion criteria

Patients with any of the following conditions will not be included in the trial:

• Known Type 1 diabetes, or treated type 2 diabetes.
• With HbA1c ≥ 7,5% at the first blood sample.
• Pregnant or lactating women.
• Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.
• Having received an investigational drug in the last 30 days before date of randomisation.
• Unable or unwilling to comply with the protocol.
• Likely to withdraw from the study before its completion.

Concomitant medications:

• With a lipid lowering drug (fibrate, statin) within the last 6 weeks before randomisation.
• Treated with antidiabetic drugs.
• Treated with Cyclosporin A.
• Change within the last 6 weeks before randomisation and during the study in the medications that could interfere with the lipid profile (i.e., anti- hypertensive drugs, oral corticosteroids, thyroid hormones, retinoids, thiazidic derivative, hormone replacement therapy).
• Treated with oral anticoagulants.
• Treated with protease inhibitors (indinavir, ritonavir, saquinavir)
• Treated against obesity: medical treatment within the last 6 weeks (orlistat, sibutramine) and/or surgery (gastroplasty, bypass).

Associated diseases or conditions:

• Diabetic ketoacidosis, diabetic pre-coma.
• Current chronic pancreatitis, or identified risk or known history of acute pancreatitis.
• Hepatic insufficiency, acute alcohol intoxication, alcoholism.
• Known cholelithiasis without cholecystectomy.
• AST and/or ALT > 2 times the upper normal limit (UNL).
• Renal failure or renal dysfunction defined by serum creatinine levels > 135 µmol/L in males and > 110 µmol/L in females.
• Recent myocardial infarction (within 3 months prior to randomisation),
• Known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomisation capable of modifying the intestinal absorption of the drugs.
• Any other severe pathology such as cancer, mental illness, etc, which in the opinion of the investigator might pose a risk to the patient or confound the results of the study.
• Blood pressure >160/100 mmHg.
• Body weight changes exceeding ± 5% of total body weight during the last three months before admission. Drugs affecting lipid and glucose metabolism, weight reducing drugs, antihypertensives and other drugs with known metabolic effects.