Abstract
BackgroundHealth benefits of the Mediterranean Diet (MD) have been shown in different at-risk populations. A German translation of the Mediterranean Diet Adherence Screener (MEDAS) from the PREvención con DIeta MEDiterránea (PREDIMED) consortium was used in the LIBRE study, investigating effects of lifestyle-intervention on women with BRCA1/2 mutations. The purpose of the present study is to validate the MEDAS German version.MethodsLIBRE is a multicentre (three university hospitals during this pilot phase), unblinded, randomized, controlled clinical trial. Women with a BRCA1/2 mutation of age 18 or over who provided written consent were eligible for the trial. As part of the assessment, all were given a full-length Food Frequency Questionnaire (FFQ) and MEDAS at baseline and after 3 months. Data derived from FFQ was compared to MEDAS in order to evaluate agreement or concordance between the two questionnaires. Additionally, the association of dietary intake biomarkers in the blood (β-carotene, omega-3, omega-6 and omega-9 fatty acids and high-sensitivity C-reactive protein (hsCRP)) with some MEDAS items was analyzed using t-Tests and a multivariate regression.ResultsThe participants of the LIBRE pilot study were 68 in total (33 Intervention, 35 Control). Only participants who completed both questionnaires were included in this analysis (baseline: 66, month three: 54). The concordance between these two questionnaires varied between the items (Intraclass correlation coefficient of 0.91 for pulses at the highest and −0.33 for sugar-sweetened drinks). Mean MEDAS scores (sum of all items) were 9% higher than their FFQ counter-parts at baseline and 15% after 3 months. Higher fish consumption (at least 3 portions) was associated with lower omega-6 fatty acid levels (p = 0.026) and higher omega-3 fatty acid levels (p = 0.037), both results being statistically significant.ConclusionsWe conclude that the German MEDAS in its current version could be a useful tool in clinical trials and in practice to assess adherence to MD.Trial registrationClinicalTrials.gov, registered on March 12, 2014, identifier: NCT02087592. World Health Organization Trial Registration, registered on 3 August 2015, identifier: NCT02087592.
Highlights
Health benefits of the Mediterranean Diet (MD) have been shown in different at-risk populations
Study population The Lifestyle intervention in BRCA 1/2-mutation carriers (LIBRE) study is divided into two parts: firstly, a feasibility study to prove the practicability of the lifestyle intervention and the presently recruiting main trial with the aim of attaining 600 study participants to demonstrate the effects of the lifestyle intervention on the breast cancer incidence in women with BRCA1 or BRCA2
The intervention group (IG) comprised 35 women at this point in time, while the control group (CG) comprised 32. Considering attributes such as Body Mass Index (BMI), age and history of breast cancer, these groups did not differ statistically significantly from one another. Both groups included a number of smokers (11% in the IG and 9% in the CG)
Summary
Health benefits of the Mediterranean Diet (MD) have been shown in different at-risk populations. A German translation of the Mediterranean Diet Adherence Screener (MEDAS) from the PREvención con DIeta MEDiterránea (PREDIMED) consortium was used in the LIBRE study, investigating effects of lifestyle-intervention on women with BRCA1/ 2 mutations. Epidemiological studies from the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort suggested further that MD might protect against cancer, especially gastric cancer [7], colorectal cancer [8] and bladder cancer [9]. Such trials raised the need for a useful tool to assess MD adherence in study populations. The PREDIMED investigators could show that MEDAS is able to capture a strong monotonic inverse association between adherence to MD and obesity indices in a population of adults with a high cardiovascular risk [12]
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