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Fruit juice, fruit and type 2 diabetes


- candidate number28781
- NTR NumberNTR7135
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-apr-2018
- Secondary IDsMEC-TNO-93/01 
- Public TitleFruit juice, fruit and type 2 diabetes
- Scientific TitlePure fruit juice and fruit consumption and the risk of type 2 diabetes: The EPIC-NL Study.
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Fruit consumption, Fruit
- Inclusion criteriaThe EPIC-NL study consists of two cohorts: the MORGEN cohort and the Prospect cohort. The MORGEN cohort consists of men and women aged 20 65 years selected from random samples of the Dutch population in three towns in the Netherlands (Amsterdam, Doetinchem, Maastricht). The Prospect cohort consists of women, from the Dutch town Utrecht or its vicinity, who participated in a breast cancer screening program.
- Exclusion criteriaPrevalent diabetes, missing FFQ, implausible energy intake, missing follow-up, missing data on confounders.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2018
- planned closingdate1-jun-2018
- Target number of participants37000
- InterventionsCox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CI) for the association of fruit juice consumption and fruit consumption with diabetes. The first model was adjusted for age and sex. The second model was adjusted for age, sex, educational level, physical activity, smoking, family history of diabetes, alcohol, DHD15-index and fruit/fruit juice consumption. In the third model energy intake and in the fourth model BMI and waist circumference were added as covariates, considering these as potential intermediate factors.
- Primary outcomeType 2 diabetes
- Secondary outcomenone
- TimepointsThree sources for identification of possible type 2 diabetes cases were used: self-report, linkage with the national hospital discharge register (HDR) and urinary glucose strip test. Firstly, self-reported occurrence of diabetes was collected with two follow-up questionnaires at 3 5 years intervals. Secondly, diagnoses of diabetes were also obtained from the HDR that holds a hospital discharge diagnosis database from 1990 onwards. Thirdly, for the Prospect cohort only, incident type 2 diabetes cases were also identified via a urinary glucose strip test, sent out with the first follow-up questionnaire, for detection of glucosuria
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Floor Scheffers
- CONTACT for SCIENTIFIC QUERIES Floor Scheffers
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports (VWS), ZonMw, European Commission, Netherlands Organisation for Scientific Research (NWO), World Cancer Research Fund
- Publications
- Brief summaryWe will study the association of pure fruit juice and fruit consumption with type 2 diabetes in the European Prospective Investigation into Cancer and Nutrition-Netherlands (EPIC-NL) cohort. Furthermore, we examine whether pure fruit juice consumption has a different effect on the risk of type 2 diabetes for low or high fruit consumers, Cox proportional hazards models will be used to estimate hazard ratios (HRs) and 95% confidence intervals (CI).
- Main changes (audit trail)
- RECORD8-apr-2018 - 15-apr-2018


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