Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dairy Products and Metabolic Effects (Norwegian Part)

This study has been completed.
Sponsor:
Collaborators:
University of Oslo
Tine BA.
Opplysningskontoret for meieriprodukter.
The Research Council of Norway
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00140816
First received: August 30, 2005
Last updated: July 3, 2011
Last verified: February 2009

August 30, 2005
July 3, 2011
September 2005
November 2008   (final data collection date for primary outcome measure)
  • Weight
  • Body mass index (BMI)
  • Waist circumference/sagittal abdominal diameter
  • Proportion of body fat (bioelectrical impedance analysis [BIA], dual energy x-ray absorptiometry [DEXA])
  • Serum lipids (triglycerides [TG], cholesterol [chol], high-density lipoprotein [HDL] chol, low-density lipoprotein [LDL] chol, apolipoprotein (apo) B, apo A1, fatty acid composition)
  • Blood glucose, HbA1c%
  • Serum insulin, C-peptide
  • Blood pressure (systolic blood pressure [SBP], diastolic blood pressure [DBP])
  • Marker of fibrinolysis: plasminogen activator inhibitor [PAI-1]
  • Markers for inflammation: micro C-reactive protein (microCRP), interleukin-6 (IL-6), 15-keto-DH-prostaglandin F2 alfa (in urine), fibrinogen
  • Markers of endothelial function: vascular cell adhesion molecule (VCAM), vWillebrand factor
  • Lipid peroxidation ("oxidative stress"): 8-F2-isoprostanes (in urine)
Same as current
Complete list of historical versions of study NCT00140816 on ClinicalTrials.gov Archive Site
  • Adiponectin, leptin
  • LDL particle size
  • Gene expression in leukocytes
  • Direct measurement of insulin sensitivity
  • Glucose tolerance test (0, 30, 60, 90, 120)
  • Fat load test (0, 4, 6)
  • Serum free fatty acids (FFA)
  • Fat content of faeces
  • Polymorphisms in genes with direct influence on relation between endogen lipid synthesis and lipid oxidation (AMP-kinase, SREBP1c, stearoyl desaturase-SCD1, acetyl-CoA carboxylase-ACC2, acyl-CoA synthetase-ACS1)
  • Adiponectin, leptin
  • LDL particle size
  • Gene expression in leukocytes
  • Direct measurement of insulin sensitivity
  • Glucose tolerance test (0, 30, 60, 90, 120)
  • Fat load Test (0, 4, 6)
  • Serum FFA
  • Fat content of faeces
  • Polymorphisms in genes with direct influence on relation between endogen lipid synthesis and lipid oxidation (AMP-kinase, SREBP1c, steaoryl desaturase-SCD1, acetyl-CoA carboxylase-ACC2, acyl-CoA syntetas-ACS1)
Not Provided
Not Provided
 
Dairy Products and Metabolic Effects (Norwegian Part)
Dairy Products and Metabolic Effects - A Multicentre Nordic Study

Foods containing more dairy fat (and thus a higher proportion of short and medium chain fatty acids and possibly some other nutrients or micronutrients with effect on energy intake, satiety or energy metabolism) affect energy balance and metabolic profile in subjects prone to develop abdominal adiposity and metabolic syndrome.

The aim of the study is to test the hypothesis that intake of dairy products has a favorable effect on markers of the metabolic syndrome.

To explore such a hypothesis the participants have to be in a free living situation during an extended study period.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Metabolic Syndrome X
  • Heart Disease
Behavioral: Increased intake of dairy products
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00140816
Melk61015
Not Provided
Not Provided
Oslo University Hospital
  • University of Oslo
  • Tine BA.
  • Opplysningskontoret for meieriprodukter.
  • The Research Council of Norway
Principal Investigator: Jan I Pedersen, Prof. dr. med. Inst. of Basic Medical Sciences, Dept. of Nutrition, University of Oslo
Oslo University Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP