Combination therapy of flaxseed and hesperidin enhances the effectiveness of lifestyle modification in cardiovascular risk control in prediabetes: a randomized controlled trial

Abstract

Background Regarding the increasing prevalence of cardiometabolic abnormalities, and its association with non-communicable chronic diseases, providing preventive and therapeutic strategies is a priority. A randomized placebo-controlled study was conducted to assess the effects of combination therapy of milled brown flaxseed and hesperidin during lifestyle intervention on controlling cardiovascular risk in prediabetes. Methods A total of 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. Changes from baseline in anthropometric measures, lipid profile and atherogenic indices, glucose homeostasis parameters, and inflammatory biomarkers was assessed as a primary end point. Results Anthropometric data comparison between the two groups showed a significant reduction in weight (p = 0.048). Waist circumference reduction was about twice that of the control group (− 6.75 cm vs − 3.57 cm), but this difference was not statistically significant. Comparison of blood pressure changes throughout the study indicated a greater reduction in blood pressure in the intervention group rather than control group (− 5.66 vs. − 1.56 mmHg, P = 0.049). Improvements of lipid profile and atherogenic indices, glucose homeostasis parameters, and inflammatory biomarkers in flaxseed-hesperidin group was significantly more than the control group after 12 weeks of intervention (p < 0.05). Conclusion 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 metabolic abnormalities remission of prediabetic patients. Trial registration: The trial was registered with ClinicalTrials.gov, number NCT03737422. Registered 11 November 2018. Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=NCT03737422&cntry=&state=&city=&dist=.

The effect of phytochemicals in prediabetic patients: A systematic review of randomized controlled trials

“…The total sample size was 2177 participants. The studies were conducted in Iran (Karandish et al, 2021; Karandish et al, 2022; Yari et al, 2021), Japan (Funamoto et al, 2019), Italy (Cicero et al, 2020; Colletta et al, 2020; Derosa, D'angelo, et al, 2020; Derosa, Maffioli, et al, 2020), China (Ming et al, 2021; Shanobin et al, 2007; Wang et al, 2020; Yang et al, 2017, 2021; Yang, Ling, et al, 2020; Yang, Liu, et al, 2020; Ye et al, 2015, 2021; Zhang et al, 2018), USA (Moreno‐Ulloa et al, 2018; Pollack et al, 2017), Brazil (Ribeiro et al, 2019), and Australia (Thota et al, 2019; Thota et al, 2020). The participants were prediabetic patients (or defined as patients with IGT, IFG, IGR, or hyperglycemia without overt diabetes).…”

“…Out of 23 included studies, 15 articles were categorized as high‐quality studies (Cicero et al, 2020; Derosa, Maffioli, et al, 2020; Funamoto et al, 2019; Karandish et al, 2021; Karandish et al, 2022; Ming et al, 2021; Ribeiro et al, 2019; Thota et al, 2019; Wang et al, 2020; Yang et al, 2017, 2021; Yang, Ling, et al, 2020; Yari et al, 2021; Ye et al, 2015, 2021), three studies had fair quality (Derosa, D'angelo, et al, 2020; Thota et al, 2020; Yang, Liu, et al, 2020), and three studies were categorized as low quality (Colletta et al, 2020; Moreno‐Ulloa et al, 2018; Pollack et al, 2017). We did not have access to the full text of two studies (Shanobin et al, 2007; Zhang et al, 2018) (Figure 2).…”

“…However, the findings of glycemic indices might be stronger than the lipid profile. In six arms, a reduction in the number of inflammatory factors was reported (Derosa, D'angelo, et al, 2020; Derosa, Maffioli, et al, 2020; Ribeiro et al, 2019; Yari et al, 2021). In our systematic review, we did not observe notable positive effects of phytochemicals on blood pressure and anthropometry indices.…”

“…Out of 23 included studies, 15 articles were categorized as highquality studies (Cicero et al, 2020;Funamoto et al, 2019;Karandish et al, 2021;Karandish et al, 2022;Ming et al, 2021;Ribeiro et al, 2019;Thota et al, 2019;Wang et al, 2020;Yang et al, 2017Yang et al, , 2021Yari et al, 2021;Ye et al, 2015Ye et al, , 2021, three studies had fair quality Thota et al, 2020;, and three studies were categorized as low quality (Colletta et al, 2020;Moreno-Ulloa et al, 2018;Pollack et al, 2017).…”

The Effect of Different Levels of Flaxseed Oil on Biochemical Changes in Hypercholesterolemic Rats

“…• Henry's, (1974) kinetic method was used to determine creatinine [17]. • Patton and Crouch's, (1977) enzymatic method was used to evaluate urea [18].…”