NCT04094194

Brief Summary

The Nordic Diet is a dietary pattern rich in traditional Nordic foods, including berries, grains, and fatty fish common in northern Europe. Studies have shown a protective effect of the Nordic Diet on cardiometabolic risk factors, however only select clinical practice guidelines for the management of diabetes (i.e. Diabetes Canada) recommend this dietary pattern. To support the update of the EASD clinical practice guidelines for nutrition therapy, the investigators propose to conduct a systematic review and meta-analysis of prospective cohort studies and clinical trials to investigate the association between the Nordic Diet, cardiometabolic outcomes and cardiovascular disease incidence and mortality. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

September 16, 2019

Last Update Submit

September 16, 2019

Conditions

Keywords

Nordic dietCardiometabolic risk factorsMortalityCardiovascular diseasesType 2 diabetesHypertensionSystematic review and meta-analysisRandomized controlled trialsProspective cohort studies

Outcome Measures

Primary Outcomes (2)

  • Incident Cardiovascular Disease (Prospective Cohort Studies)

    Relative Risks

    Time Frame: At least 1 year

  • LDL-cholesterol (randomized and non-randomized controlled trials)

    Mean difference

    Time Frame: Up to 20 years

Secondary Outcomes (15)

  • Glycemic control - Fasting blood glucose (randomized and non-randomized controlled trials)

    Time Frame: Up to 20 years

  • Glycemic control - HbA1c (randomized and non-randomized controlled trials)

    Time Frame: Up to 20-years

  • Glycemic control - Fasting insulin (randomized and non-randomized controlled trials)

    Time Frame: Up to 20-years

  • Blood lipids - non-HDL-cholesterol (randomized and non-randomized controlled trials)

    Time Frame: Up to 20-years

  • Blood lipids - HDL-cholesterol (randomized and non-randomized controlled trials)

    Time Frame: Up to 20-years

  • +10 more secondary outcomes

Interventions

Healthy dietary pattern that is consumed in Nordic countries

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All individuals, both children, and adults, regardless of health status.

You may qualify if:

  • dietary trials in humans
  • Nordic diets intervention
  • Presence of an adequate comparator (ad libitum control)
  • Diet duration \>=3 weeks
  • Viable outcome data
  • Prospective cohort studies
  • Duration \>= 1 year
  • Assessment of the exposure of a Nordic Diet
  • Ascertainment of viable data by level of exposure

You may not qualify if:

  • Non-human trials
  • Observational studies
  • Lack of suitable comparator diet (i.e. non-isocaloric)
  • Diet duration \<3-weeks
  • No viable outcome data
  • Ecological, cross-sectional, retrospective observational studies, clinical trials, and non-human studies
  • Duration \< 1 year
  • non assessment of exposure of a Nordic diet
  • No ascertainment viable clinical outcome data by level of exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (8)

  • Salas-Salvado J, Bullo M, Babio N, Martinez-Gonzalez MA, Ibarrola-Jurado N, Basora J, Estruch R, Covas MI, Corella D, Aros F, Ruiz-Gutierrez V, Ros E; PREDIMED Study Investigators. Reduction in the incidence of type 2 diabetes with the Mediterranean diet: results of the PREDIMED-Reus nutrition intervention randomized trial. Diabetes Care. 2011 Jan;34(1):14-9. doi: 10.2337/dc10-1288. Epub 2010 Oct 7.

    PMID: 20929998BACKGROUND
  • Fung TT, Rexrode KM, Mantzoros CS, Manson JE, Willett WC, Hu FB. Mediterranean diet and incidence of and mortality from coronary heart disease and stroke in women. Circulation. 2009 Mar 3;119(8):1093-100. doi: 10.1161/CIRCULATIONAHA.108.816736. Epub 2009 Feb 16.

    PMID: 19221219BACKGROUND
  • Papadaki A, Scott JA. The impact on eating habits of temporary translocation from a Mediterranean to a Northern European environment. Eur J Clin Nutr. 2002 May;56(5):455-61. doi: 10.1038/sj.ejcn.1601337.

    PMID: 12001018BACKGROUND
  • Adamsson V, Reumark A, Cederholm T, Vessby B, Riserus U, Johansson G. What is a healthy Nordic diet? Foods and nutrients in the NORDIET study. Food Nutr Res. 2012;56. doi: 10.3402/fnr.v56i0.18189. Epub 2012 Jun 27.

    PMID: 22761599BACKGROUND
  • Adamsson V, Reumark A, Fredriksson IB, Hammarstrom E, Vessby B, Johansson G, Riserus U. Effects of a healthy Nordic diet on cardiovascular risk factors in hypercholesterolaemic subjects: a randomized controlled trial (NORDIET). J Intern Med. 2011 Feb;269(2):150-9. doi: 10.1111/j.1365-2796.2010.02290.x. Epub 2010 Oct 22.

    PMID: 20964740BACKGROUND
  • Roswall N, Sandin S, Scragg R, Lof M, Skeie G, Olsen A, Adami HO, Weiderpass E. No association between adherence to the healthy Nordic food index and cardiovascular disease amongst Swedish women: a cohort study. J Intern Med. 2015 Nov;278(5):531-41. doi: 10.1111/joim.12378. Epub 2015 May 19.

    PMID: 25991078BACKGROUND
  • Kanerva N, Kaartinen NE, Rissanen H, Knekt P, Eriksson JG, Saaksjarvi K, Sundvall J, Mannisto S. Associations of the Baltic Sea diet with cardiometabolic risk factors--a meta-analysis of three Finnish studies. Br J Nutr. 2014 Aug 28;112(4):616-26. doi: 10.1017/S0007114514001159. Epub 2014 May 27.

    PMID: 24867656BACKGROUND
  • Massara P, Zurbau A, Glenn AJ, Chiavaroli L, Khan TA, Viguiliouk E, Mejia SB, Comelli EM, Chen V, Schwab U, Riserus U, Uusitupa M, Aas AM, Hermansen K, Thorsdottir I, Rahelic D, Kahleova H, Salas-Salvado J, Kendall CWC, Sievenpiper JL. Nordic dietary patterns and cardiometabolic outcomes: a systematic review and meta-analysis of prospective cohort studies and randomised controlled trials. Diabetologia. 2022 Dec;65(12):2011-2031. doi: 10.1007/s00125-022-05760-z. Epub 2022 Aug 26.

MeSH Terms

Conditions

Body WeightObesityOverweightObesity, AbdominalHypertensionHyperlipidemiasCardiovascular DiseasesCoronary DiseaseStrokeDyslipidemiasDiabetes MellitusPrediabetic StateMetabolic SyndromeDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesVascular DiseasesLipid Metabolism DisordersMetabolic DiseasesMyocardial IschemiaHeart DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGlucose Metabolism DisordersEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • John Sievenpiper, MD,PhD,FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FRCPC

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 18, 2019

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations