AzTrials
AzTrials

Metabolic Syndrome XNCT00140816

Dairy Products and Metabolic Effects (Norwegian Part)

A study testing Increased intake of dairy products in people with Metabolic Syndrome X and Heart Disease, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome X, Heart Disease
What is being tested?
Increased intake of dairy products
How many people
40 participants
Where
1 siteNorway
Study dates
Sep 2005to Nov 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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).

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Lipidklinikken, Medisinsk avdeling, Rikshospitalet

    Oslo, 0027

Other trials in Norway

About this study

Official title: 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.

Being tested
Increased intake of dairy products
Medical subject headings
Metabolic Syndrome, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Increased intake of dairy productsBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

  2. Body mass index (BMI)

  3. Waist circumference/sagittal abdominal diameter

  4. Proportion of body fat (bioelectrical impedance analysis [BIA], dual energy x-ray absorptiometry [DEXA])

  5. Serum lipids (triglycerides [TG], cholesterol [chol], high-density lipoprotein [HDL] chol, low-density lipoprotein [LDL] chol, apolipoprotein (apo) B, apo A1, fatty acid composition)

  6. Blood glucose, HbA1c%

  7. Serum insulin, C-peptide

  8. Blood pressure (systolic blood pressure [SBP], diastolic blood pressure [DBP])

  9. Marker of fibrinolysis: plasminogen activator inhibitor [PAI-1]

  10. Markers for inflammation: micro C-reactive protein (microCRP), interleukin-6 (IL-6), 15-keto-DH-prostaglandin F2 alfa (in urine), fibrinogen

  11. Markers of endothelial function: vascular cell adhesion molecule (VCAM), vWillebrand factor

  12. Lipid peroxidation ("oxidative stress"): 8-F2-isoprostanes (in urine)

Secondary outcomes (9)

  1. Adiponectin, leptin

  2. LDL particle size

  3. Gene expression in leukocytes

  4. Direct measurement of insulin sensitivity

  5. Glucose tolerance test (0, 30, 60, 90, 120)

  6. Fat load test (0, 4, 6)

  7. Serum free fatty acids (FFA)

  8. Fat content of faeces

  9. 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00140816
Sponsor's protocol ID
Melk61015
Status last verified
Feb 2009
First submitted
30 Aug 2005
Last updated
6 Jul 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Increased intake of dairy products in people with Metabolic Syndrome X and Heart Disease, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight. The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00140816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in