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Effect of a lifestyle intervention program with energy-restricted Mediterranean diet and exercise on the serum polyamine metabolome in individuals at high cardiovascular disease risk: a randomized clinical trial
Fernandez-Garcia JC, Martinez-Sanchez MA, Bernal-Lopez MR, Munoz-Garach A, Martinez-Gonzalez MA, Fito M, Salas-Salvado J, Tinahones FJ, Ramos-Molina B
The American Journal of Clinical Nutrition 2020 May;111(5):975-982
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Many food items included in the Mediterranean diet (MedDiet) are rich in polyamines, small aliphatic amines with potential cardioprotective effects. The consumption of a MedDiet could increase polyamine concentrations. Based on experimental models, polyamine concentrations may be also influenced by physical activity (PA). OBJECTIVES: We aimed to evaluate whether an intervention based on an energy-restricted MedDiet (er-MedDiet) and PA promotion, in comparison with an energy-unrestricted MedDiet and traditional health care, influences the serum pattern of polyamines and related metabolites in subjects at high risk of cardiovascular disease (CVD). METHODS: This was a substudy from the PREDIMED-plus trial, an ongoing randomized clinical trial including 6,874 participants allocated either to an intensive weight-loss lifestyle intervention based on er-MedDiet, PA promotion, and behavioral support (er-MedDiet+PA group), or to an energy-unrestricted MedDiet and traditional health care group (MedDiet group). A total of 75 patients (n = 38, er-MedDiet+PA group; n = 37, MedDiet group) were included in this study. Serum concentrations of arginine, ornithine, polyamines, and acetyl polyamines at baseline and 26 wk of intervention were measured by an ultra-high-performance LC-tandem MS platform. RESULTS: At week 26, study groups had similar adherence to the MedDiet but patients randomly assigned to the er-MedDiet+PA group showed significantly lower mean energy intake (-340.3 kcal/d; 95% CI -567.3 to -113.4 kcal/d; p = 0.004), higher mean PA (1,290.6; 95% CI 39.9 to 2,541.3 metabolic equivalent tasks min/d; p = 0.043), and higher mean decrease in BMI (in kg/m2) (-1.3; 95% CI -1.8 to -0.6; p < 0.001) than the MedDiet group. However, no significant differences in serum polyamines or related metabolites were found between study groups after 26 wk of intervention and no significant between-group differences were found in glycated hemoglobin, HDL-cholesterol, or triglyceride concentrations. CONCLUSIONS: In individuals at high CVD risk, an er-MedDiet with increased PA did not result in significant changes of serum concentrations of polyamines or related metabolites in comparison with an energy-unrestricted MedDiet and no increase in PA. This trial was registered at isrctn.com as ISRCTN89898870.
Copyright by the American Society for Clinical Nutrition.

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