Combination Therapy of Flaxseed and Hesperidin Enhances the Effectiveness of Lifestyle Modification in Metabolic Syndrome: A Randomized Controlled Clinical Trial

Background and Objectives: Regarding the increasing prevalence of metabolic syndrome (MetS), and its association with non-communicable chronic diseases, providing preventive and therapeutic strategies is a priority. A randomized controlled study was conducted to assess the effects of combination therapy of milled brown flaxseed and hesperidin during lifestyle intervention on MetS components. Materials and Methods: Forty-eight subjects were randomly assigned to receive lifestyle intervention plus combination therapy of brown flaxseed (30 g milled) and hesperidin (two 500 mg capsules) or lifestyle modification alone for 12 weeks. MetS was assessed as a primary endpoint. The trial was registered in clinicaltrial.gov:NCT03737422. Results: Forty-six percent of patients in the flaxseed-hesperidin group experienced more than three MetS factors improvement from baseline to week 12, while only 17% of patients in the control group fall in this category. A comparison of blood pressure changes throughout the study indicated a greater reduction in blood pressure in the intervention group rather than in the control group (-5.66 vs. -1.56 mmHg, P = 0.049). The reduction in plasma glucose (-20.35 vs. -7.46 mg/dL, P = 0.007) and triglyceride (-45.3 vs. -8.39 mg/dL, P = 0.020) in the flaxseed-hesperidin group was significantly more than the control group after 12 weeks of intervention. Conclusions: Our results indicate that co-administration of flaxseed and hesperidin as an adjunct to lifestyle modification program is more effective than lifestyle modification alone in the treatment of metabolic syndrome.