NCT00140816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

July 6, 2011

Status Verified

February 1, 2009

Enrollment Period

3.2 years

First QC Date

August 30, 2005

Last Update Submit

July 3, 2011

Conditions

Metabolic Syndrome XHeart Disease

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (9)

  • Adiponectin, leptin

  • LDL particle size

  • Gene expression in leukocytes

  • Direct measurement of insulin sensitivity

  • Glucose tolerance test (0, 30, 60, 90, 120)

  • +4 more secondary outcomes

Interventions

Increased intake of dairy productsBEHAVIORAL

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lipidklinikken, Medisinsk avdeling, Rikshospitalet

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Metabolic SyndromeHeart Diseases

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCardiovascular Diseases

Study Officials

  • Jan I Pedersen, Prof. dr. med.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

September 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

July 6, 2011

Record last verified: 2009-02

Locations

NO(1)