Dairy Products and Metabolic Effects (Norwegian Part)

NCT ID: NCT00140816

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-11-30

Brief Summary

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.

Conditions

Metabolic Syndrome X; Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

Increased intake of dairy products

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Tine

INDUSTRY

Sponsor Role: collaborator

Opplysningskontoret for meieriprodukter.

UNKNOWN

Sponsor Role: collaborator

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jan I Pedersen, Prof. dr. med.

Role: PRINCIPAL_INVESTIGATOR

Inst. of Basic Medical Sciences, Dept. of Nutrition, University of Oslo

Locations

Lipidklinikken, Medisinsk avdeling, Rikshospitalet

Oslo, , Norway

Countries

Norway

Other Identifiers

Melk61015

Identifier Type: -

Identifier Source: org_study_id