Effects of Fasting and Lifestyle Modification in Patients with Metabolic Syndrome: A Randomized Controlled Trial
Creators: name: Cramer, Holger
name: Hohmann, Christoph
name: Lauche, Romy
name: Choi, Kyung-Eun Anna
name: Schneider, Nadia
name: Steckhan, Nico
name: Rathjens, Florian
name: Anheyer, Dennis
name: Paul, Anna
name: Scheidt, Christel Von
name: Ostermann, Thomas
name: Schneider, Elisabeth
name: Koppold-Liebscher, Daniela A.
name: Kessler, Christian S.
name: Dobos, Gustav
name: Michalsen, Andreas
name: Jeitler, Michael
Publisher: name: Charité - Universitätsmedizin Berlin
Year: 2022
Subjects: subject: fasting
subject: metabolic syndrome
subject: modified DASH diet
subject: Mediterranean diet
subject: lifestyle
subject: relaxation
subject: MICOM (mind-body medicine in integrative and complementary medicine)
subject: 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit

description: Background: Lifestyle interventions, such as fasting, diet, and exercise, are increasingly used as a treatment option for patients with metabolic syndrome (MS). This study assesses the efficacy and safety of fasting followed by lifestyle modification in patients with MS compared to lifestyle modification only. Methods: Single-blind, multicenter, parallel, randomized controlled trial in two German tertiary referral hospitals in metropolitan areas. Interventions: (a) 5-day fasting followed by 10 weeks of lifestyle modification (modified DASH diet, exercise, mindfulness; n = 73); (b) 10 weeks of lifestyle modification only (n = 72). Main outcomes and measures: Co-primary outcomes were ambulatory systolic blood pressure and the homeostasis model assessment (HOMA) index at week 12. Further outcomes included anthropometric, laboratory parameters, and the PROCAM score at weeks 1, 12, and 24. Results: A total of 145 patients with metabolic syndrome (62.8% women; 59.7 +/- 9.3 years) were included. No significant group differences occurred for the co-primary outcomes at week 12. However, compared to lifestyle modification only, fasting significantly reduced HOMA index (Delta = -0.8; 95% confidence interval [CI] = -1.7, -0.1), diastolic blood pressure (Delta = -4.8; 95% CI = -5.5, -4.1), BMI (Delta = -1.7; 95% CI = -2.0, -1.4), weight (Delta = -1.7; 95% CI = -2.0, -1.4), waist circumference (Delta = -2.6; 95% CI = -5.0, -0.2), glucose (Delta = -10.3; 95% CI = -19.0, -1.6), insulin (Delta = -2.9; 95% CI = -5.3, -0.4), HbA1c (Delta = -0.2; 95% CI = -0.4, -0.05;), triglycerides (Delta = -48.9; 95% CI = -81.0, -16.9), IL-6 (Delta = -1.2; 95% CI = -2.5, -0.005), and the 10-year risk of acute coronary events (Delta = -4.9; 95% CI = -9.5, -0.4) after week 1. Fasting increased uric acid levels (Delta = 1.0; 95% CI = 0.1, 1.9) and slightly reduced eGRF (Delta = -11.9; 95% CI = -21.8, -2.0). Group differences at week 24 were found for weight (Delta = -2, 7; 95% CI = -4.8, -0.5), BMI (Delta = -1.0; 95% CI = -1.8, -0.3), glucose (Delta = -7.7; 95% CI = -13.5, -1.8), HDL (Delta = 5.1; 95% CI = 1.5, 8.8), and CRP (Delta = 0.2; 95% CI = 0.03, 0.4). No serious adverse events occurred. Conclusions: A beneficial effect at week 24 was found on weight; fasting also induced various positive short-term effects in patients with MS. Fasting can thus be considered a treatment for initializing lifestyle modification for this patient group; however, it remains to be investigated whether and how the multilayered effects of fasting can be maintained in the medium and longer term.