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Insulin ResistanceNCT00405197

MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

A study testing Isocaloric diet high in MUFA or Mediterranean diet in people with Insulin Resistance and Metabolic Syndrome X, run by Wageningen University at 2 sites in Netherlands.

Completed

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

Official record
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Trial summary

Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is expected to increasing. Prevention is therefore warranted. In this respect the amount and type of fat in the diet deserves attention. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
What is being tested?
Isocaloric diet high in MUFA or Mediterranean diet
How many people
60 participants
Where
2 sitesNetherlands
Study dates
Nov 2006to Apr 2007
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 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Waist circumference ≥ 94 cm for men or ≥ 80 cm for women
  • Age from 40 to 65 years at the time of randomisation
  • Written informed consent obtained

Who cannot join

  • Unable or unwilling to comply with study procedures.
  • The use of drugs for lowering serum cholesterol, serum triglycerides, blood pressure, or diabetes.
  • Unusual dietary patterns, including high alcohol intakes
  • Recent (< 4 weeks) or current participation in a study with any investigational drug or dietary intervention.
  • High concentrations of total cholesterol (>8 mmol/L).
  • Diabetes mellitus.
  • Being pregnant or giving breastfeeding.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Hospital Gelderse Vallei

    Ede, 6710 HN

  • Wageningen University, Division of Human Nutrition

    Wageningen

Other trials in Netherlands

About this study

Official title: Study on the Effect of Mono-Unsaturated Fatty Acids (MUFA) and the Mediterranean Diet on Hyperinsulinemia and Other Components of the Metabolic Syndrome

Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is expected to increasing. Prevention is therefore warranted. In this respect the amount and type of fat in the diet deserves attention. Recently, an intervention study reported that a diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin sensitivity in healthy subjects. However, additional beneficial effects can be expected from the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a typical Mediterranean diet will even have more pronounced effects. Study objectives: To investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets for a period of 8 weeks. Measurements of serum insulin concentration and other parameters will be carried out at weeks 2 and 10. Expected results: Our study will provide information on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean type of diet on the metabolic syndrome.

Being tested
Isocaloric diet high in MUFA or Mediterranean diet
Keywords
MUFA, Mediterranean diet, Insulin resistance, metabolic syndrome X
Medical subject headings
Insulin Resistance, Metabolic Syndrome, Dyslipidemias, Hypertension, Overweight

What participants receive

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

  • Isocaloric diet high in MUFA or Mediterranean dietBehavioural

What is being measured

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

  1. Fasting Insulin

Secondary outcomes (10)

  1. Systolic/ diastolic blood pressure

  2. plasma glucose

  3. serum HDL-cholesterol

  4. serum triglycerides

  5. waist-hip circumference

  6. serum total cholesterol

  7. serum LDL-cholesterol

  8. Blood sample will be stored for measuring markers of inflammation.

  9. Additionally in half of the subjects insulin sensitivity will be measured by the euglycemic hyperinsulinemic clamp.

  10. Molecular markers in fat and muscle biopsies

Timeline

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

  1. First posted29 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Study completionApr 2007

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00405197
Sponsor's protocol ID
NHS 2003B068
Status last verified
Dec 2007
First submitted
28 Nov 2006
Last updated
12 Dec 2007
Results posted
No

Publications

  • Esposito K, Marfella R, Ciotola M, Di Palo C, Giugliano F, Giugliano G, D'Armiento M, D'Andrea F, Giugliano D. Effect of a mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial. JAMA. 2004 Sep 22;292(12):1440-6. doi: 10.1001/jama.292.12.1440.

    PubMed 15383514

  • Vessby B, Uusitupa M, Hermansen K, Riccardi G, Rivellese AA, Tapsell LC, Nalsen C, Berglund L, Louheranta A, Rasmussen BM, Calvert GD, Maffetone A, Pedersen E, Gustafsson IB, Storlien LH; KANWU Study. Substituting dietary saturated for monounsaturated fat impairs insulin sensitivity in healthy men and women: The KANWU Study. Diabetologia. 2001 Mar;44(3):312-9. doi: 10.1007/s001250051620.

    PubMed 11317662

  • Panagiotakos DB, Polychronopoulos E. The role of Mediterranean diet in the epidemiology of metabolic syndrome; converting epidemiology to clinical practice. Lipids Health Dis. 2005 Apr 12;4:7. doi: 10.1186/1476-511X-4-7.

    PubMed 15826300

  • Serra-Majem L, Roman B, Estruch R. Scientific evidence of interventions using the Mediterranean diet: a systematic review. Nutr Rev. 2006 Feb;64(2 Pt 2):S27-47. doi: 10.1111/j.1753-4887.2006.tb00232.x.

    PubMed 16532897

  • van Dijk SJ, Feskens EJ, Bos MB, de Groot LC, de Vries JH, Muller M, Afman LA. Consumption of a high monounsaturated fat diet reduces oxidative phosphorylation gene expression in peripheral blood mononuclear cells of abdominally overweight men and women. J Nutr. 2012 Jul;142(7):1219-25. doi: 10.3945/jn.111.155283. Epub 2012 May 23.

    PubMed 22623392

  • van Dijk SJ, Feskens EJ, Bos MB, Hoelen DW, Heijligenberg R, Bromhaar MG, de Groot LC, de Vries JH, Muller M, Afman LA. A saturated fatty acid-rich diet induces an obesity-linked proinflammatory gene expression profile in adipose tissue of subjects at risk of metabolic syndrome. Am J Clin Nutr. 2009 Dec;90(6):1656-64. doi: 10.3945/ajcn.2009.27792. Epub 2009 Oct 14.

    PubMed 19828712

Questions about this trial

What is this clinical trial studying?

A study testing Isocaloric diet high in MUFA or Mediterranean diet in people with Insulin Resistance and Metabolic Syndrome X, run by Wageningen University at 2 sites in Netherlands.

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 3 inclusion and 7 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 12 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

Fasting Insulin. 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 NCT00405197, which also lists 6 linked publications.

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 12 Dec 2007.

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