The effect of green Mediterranean diet on cardiometabolic risk; a randomised controlled trial.

BACKGROUND: A Mediterranean diet is favourable for cardiometabolic risk. OBJECTIVE: To examine the residual effect of a green Mediterranean diet, further enriched with green plant-based foods and lower meat intake, on cardiometabolic risk. METHODS: For the DIRECT-PLUS parallel, randomised clinical trial we assigned individuals with abdominal obesity/dyslipidaemia 1:1:1 into three diet groups: healthy dietary guidance (HDG), Mediterranean and green Mediterranean diet, all combined with physical activity. The Mediterranean diets were equally energy restricted and included 28 g/day walnuts. The green Mediterranean diet further included green tea (3-4 cups/day) and a Wolffia globosa (Mankai strain; 100 g/day frozen cubes) plant-based protein shake, which partially substituted animal protein. We examined the effect of the 6-month dietary induction weight loss phase on cardiometabolic state. RESULTS: Participants (n=294; age 51 years; body mass index 31.3 kg/m2; waist circumference 109.7 cm; 88% men; 10 year Framingham risk score 4.7%) had a 6-month retention rate of 98.3%. Both Mediterranean diets achieved similar weight loss ((green Mediterranean -6.2 kg; Mediterranean -5.4 kg) vs the HDG group -1.5 kg; p<0.001), but the green Mediterranean group had a greater reduction in waist circumference (-8.6 cm) than the Mediterranean (-6.8 cm; p=0.033) and HDG (-4.3 cm; p<0.001) groups. Stratification by gender showed that these differences were significant only among men. Within 6 months the green Mediterranean group achieved greater decrease in low-density lipoprotein cholesterol (LDL-C; green Mediterranean -6.1 mg/dL (-3.7%), -2.3 (-0.8%), HDG -0.2 mg/dL (+1.8%); p=0.012 between extreme groups), diastolic blood pressure (green Mediterranean -7.2 mm Hg, Mediterranean -5.2 mm Hg, HDG -3.4 mm Hg; p=0.005 between extreme groups), and homeostatic model assessment for insulin resistance (green Mediterranean -0.77, Mediterranean -0.46, HDG -0.27; p=0.020 between extreme groups). The LDL-C/high-density lipoprotein cholesterol (HDL-C) ratio decline was greater in the green Mediterranean group (-0.38) than in the Mediterranean (-0.21; p=0.021) and HDG (-0.14; p<0.001) groups. High-sensitivity C-reactive protein reduction was greater in the green Mediterranean group (-0.52 mg/L) than in the Mediterranean (-0.24 mg/L; p=0.023) and HDG (-0.15 mg/L; p=0.044) groups. The green Mediterranean group achieved a better improvement (-3.7% absolute risk reduction) in the 10-year Framingham Risk Score (Mediterranean-2.3%; p=0.073, HDG-1.4%; p<0.001). CONCLUSIONS: The green MED diet, supplemented with walnuts, green tea and Mankai and lower in meat/poultry, may amplify the beneficial cardiometabolic effects of Mediterranean diet. TRIAL REGISTRATION NUMBER: This study is registered under ClinicalTrials.gov Identifier no NCT03020186.

Risk factors associated with neonatal thrombocytopenia in pregnant women with immune thrombocytopenic purpura.

Objectives: To characterize the risk factors associated with neonatal thrombocytopenia among pregnant women with immune thrombocytopenic purpura (ITP).Methods: We reviewed the records of ITP patients who delivered during 2006-2016 at our medical center.Results: Of 253 pregnancies, median maternal age at diagnosis was 29 [25-33] years, 222 (87.7%) had previously-diagnosed ITP and 31 (12.3%) were diagnosed with new-onset ITP during pregnancy. Baseline characteristics were comparable between the groups except for a higher proportion of nulliparity among those with new-onset disease (p = .002). Maternal nadir platelet count was significantly lower among those with new-onset compared to previously diagnosed ITP (median 62 × 109/L versus 81 × 109/L, p = .005). Neonatal thrombocytopenia (<150 × 109/L) was encountered in 24 (9.5%) pregnancies and required treatment in 12 (50%) of them. Neonatal platelet count was directly correlated with maternal platelet count at delivery (r = 0.23, p = .01), with significantly lower maternal platelet count among those whose newborns experienced thrombocytopenia (p < .001). Neonatal thrombocytopenia followed a higher proportion of pregnancies of women with new-onset than previously diagnosed ITP (22.6 versus 7.7%, p = .02). In multivariate analysis, the presence of new-onset ITP (odds ratio [95% CI]: 4.88 (1.68, 14.16), p = .004) was the only independent predictor of the development of neonatal thrombocytopenia.Conclusion: Neonatal thrombocytopenia presented following almost one-tenth of pregnancies with ITP. New pregnancy-onset disease was the only prognostic marker for neonatal thrombocytopenia. This finding could contribute to risk stratification and individualized patient management.

Clinical characteristics, neonatal risk and recurrence rate of gestational thrombocytopenia with platelet count <100 × 109/L.

OBJECTIVE: Gestational thrombocytopenia (GT) accounts for 75% of cases of thrombocytopenia in pregnancy. In most cases of GT, thrombocytopenia is mild (100-150 × 109/L) and has no consequences for either the mother or the fetus. We aimed to investigate the characteristics, neonatal risk and recurrence rate of GT with a platelet count <100 × 109/L. STUDY DESIGN: We reviewed the records of women who delivered during 2006-2016 at a large tertiary care university hospital, and who had platelet count <100 × 109/L during pregnancy. RESULTS: Of 97 pregnancies in which platelet count lower than 100 × 109/L was encountered, 66 (68%) were diagnosed as GT and 31 (32%) as new-onset immune-thrombocytopenic purpura (ITP). The proportions of women with onset of thrombocytopenia in early pregnancy (P = 0.004) and a lower maternal nadir platelet count (P = 0.01) were higher among those with new-onset ITP than GT. There was no difference in the rate of neonatal thrombocytopenia (<100 × 109/L) between those with newly diagnosed ITP and GT (16.1% vs. 10.6%, P = 0.51). Among women with GT, the rate of neonatal thrombocytopenia was higher in those who experienced antepartum bleeding (P = 0.009) and in whom the onset of thrombocytopenia was in early pregnancy (P = 0.002). Of 40 subsequent pregnancies, a recurrence of GT (<100 × 109/L) was encountered in 22 (55%), with similar maternal and perinatal outcomes compared to the initial pregnancy. CONCLUSION: The risk of neonatal thrombocytopenia was substantial, with no difference found between those with GT and new-onset ITP. The recurrence rate of GT was high in subsequent pregnancies.