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.

Study Overview

• Status: Completed
• Conditions: Heart Disease; Metabolic Syndrome X
• Intervention / Treatment: Behavioral: Increased intake of dairy products

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0027
    • Lipidklinikken, Medisinsk avdeling, Rikshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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)

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; The Research Council of Norway; Tine; Opplysningskontoret for meieriprodukter.
• Investigators: Principal Investigator: Jan I Pedersen, Prof. dr. med., Inst. of Basic Medical Sciences, Dept. of Nutrition, University of Oslo

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: August 30, 2005
• First Submitted That Met QC Criteria: August 31, 2005
• First Posted (Estimate): September 1, 2005

Study Record Updates

• Last Update Posted (Estimate): July 6, 2011
• Last Update Submitted That Met QC Criteria: July 3, 2011
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Heart Diseases; Metabolic Syndrome
• Other Study ID Numbers: Melk61015