Relative validity and reproducibility of the CyFFQ semiquantitative food frequency questionnaire for assessing dietary intake in Cypriot adults.

BACKGROUND: Assessment of dietary intake is fundamental for evaluating the interrelationships between diet and disease. The present study aimed to develop and validate the semiquantitative Cypriot food frequency questionnaire (CyFFQ). METHODS: A 171-item paper-and-pencil semiquantitative interview-administered FFQ was developed, including local foods and culturally specific meals commonly consumed among Cypriot adults. FFQ reproducibility was assessed by comparing the energy-adjusted daily macro- and micronutrients intake at baseline (FFQ1) and 1 year later (FFQ2) using a Wilcoxon matched pairs signed rank test and intraclass correlation coefficients (ICCs) in a random sample of Cypriot adults. FFQ relative validity was evaluated by comparing the intake as estimated by FFQ2 with that obtained from the average of three 24-h recalls taken over the year between FFQ1 and FFQ2. Associations between nutrient intakes estimated using FFQ2 and the 24-h recalls were assessed using Spearman rank correlation and Bland-Altman plots were used to assess agreement between the FFQ and the 24-h recalls. RESULTS: Among eligible participants, 68 (78%) completed the study (44.1% males, aged 30.5-47.5 years). The energy-adjusted intakes of macro- and micronutrients did not significantly differ between the two FFQs, excluding magnesium. The FFQ2 and the averaged 24-h recalls were significantly correlated for most macro- and micronutrients. The median (interquartile) ICC for all macro- and micronutrients was 0.46 (0.38-0.52) (p < 0.05). Agreement was satisfactory (>30%) for most micro- and macronutrients. Bland-Altman plots also confirmed good agreement between the two methods. CONCLUSIONS: The CyFFQ is a valid and reliable tool for assessing dietary consumption in Cypriot adults.

Phase III, randomised, double-blind, placebo-controlled trial of Neuroaspis plp10 as an adjuvant treatment for relapsing multiple sclerosis: the MINERAL Study.

Objectives: To assess the effectiveness of Neuroaspis plp10 nutritional supplement when added to interferon (IFN)-ß treatment in patients with relapsing-remitting multiple sclerosis (RRMS). Design: A 30-month phase III multicentre, randomised, double-blind, placebo-controlled trial. Randomisation stratified by centre using a computer-generated procedure with Neuroaspis plp10 versus placebo in 1:1 ratio. The first 6 months were used as both the pre-entry and normalisation period. Setting: 3 teaching hospitals in Greece and 1 Neurology Institute in Cyprus. Participants: 61 patients with RRMS on IFN-ß were randomly assigned to receive Neuroaspis plp10 (n=32) or placebo (n=29), 20 mL, orally, once daily, for 30 months. Intervention: Neuroaspis plp10, a cocktail mixture, containing specific PUFA (12 150 mg) and γ-tocopherol (760 mg) versus virgin olive oil (placebo). Main outcome measure: The primary end point was the annual relapse rate (ARR) whereas the secondary ones were the rate of sustained progression of disability, as measured by the Expanded Disability Status Scale (EDSS) and the brain T2 and gadolinium-enhancing lesions, at 2 years. Results: For the intention-to-treat analyses Neuroaspis plp10 significantly reduced the ARR by 80%, (RRR, 0.20; 95% CI: 0.09 to 0.45; p=0.0001) and the risk of sustained progression of disability by 73% (HR, 0.27; 95% CI: 0.09 to 0.83; p=0.022) versus placebo, at 2 years. The number of T1 gadolinium-enhancing lesions and the number of new/enlarged T2-hyperintense lesions were significantly reduced (p=0.01 and p<0.0001, respectively). Both T1-enhancing and new/enlarging T2-hyperintense lesions were significantly reduced (p=0.05 and p<0.0001, respectively). No significant adverse events were reported. Conclusions: Neuroaspis plp10 added to IFN-ß was significantly more effective than IFN-ß alone in patients with RRMS. Trial registration number: ISRCTN06166891.