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
  Purpose

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.


Condition Intervention
Metabolic Syndrome X
Heart Disease
Behavioral: Increased intake of dairy products

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Dairy Products and Metabolic Effects - A Multicentre Nordic Study

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 40
Study Start Date: September 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140816

Locations
Norway
Lipidklinikken, Medisinsk avdeling, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Tine BA.
Opplysningskontoret for meieriprodukter.
The Research Council of Norway
Investigators
Principal Investigator: Jan I Pedersen, Prof. dr. med. Inst. of Basic Medical Sciences, Dept. of Nutrition, University of Oslo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00140816     History of Changes
Other Study ID Numbers: Melk61015
Study First Received: August 30, 2005
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Heart Diseases
Metabolic Syndrome X
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 18, 2014