The effect of the fenugreek hydrolyzed protein on lipid profile in patients with mild-to-moderate hypercholesterolemia: A confirmatory triple-blind randomized-controlled clinical trial.

Background: The risk of coronary artery disease in people with high serum cholesterol is more than twice as high as in those with moderate serum cholesterol. Natural medicines, especially herbs, have been the focus of attention for many years because of the desirable and minimal side effects for controlling blood lipids. Purpose: The present study aims to investigate the effect of fenugreek hydrolyzed protein (FHP) on lipid profile in patients with mild-to-moderate hypercholesterolemia. Methods: This study is a confirmatory, triple-blind, two-group parallel, randomized controlled trial, phase 3 conducted on patients aged 18-65 years with mild-to-moderate hypercholesterolemia and low risk for cardiovascular disease. Patients were recruited from a private clinic from May 2021 to June 2021. Sixty patients were randomized with a 1:1 allocation ratio into the FHP group (N = 30) and the placebo group (N = 30). The intervention group was administrated 40 mg/day of FHP for 8 weeks. Patients were examined at baseline and 8 weeks after randomization. The primary outcome was the patient's lipid profile including total cholesterol (TC), high-density lipoprotein (HDL-c), low-density lipoprotein (LDL-c), triglyceride (TG), and non-HDL-c. All participants, caregivers, outcome assessors, and analyzers were blind to the type of intervention. Results: In the intervention group, lipid profile improved through a significant reduction in TC (P < 0.001), LDL-c (P = 0.043), and non-HDL-c (P < 0.001), but no significant changes were observed in the TG level. The mean difference of these variables was -10.07 mg/dl [95 %CI:30.84; 10.70], -8.93 mg/dl [95 %CI:27.07; 9.21], and -10.37 mg/dl [95 %CI:32.26; 11.52] for TC, LDL-c, and non-HDL-c, respectively. FHP successfully decreased LDL-c level by 7 %. There was no significant change in any component of the lipid profile in the comparison group. FHP was well tolerated with only 1 patient experiencing gastrointestinal adverse manifestations. Conclusion: These findings suggest that FHP administration can improve the lipid profile of patients with mild-to-moderate hypercholesterolemia. Considering the low adverse effects of FHP and patients' high tolerance, it can be considered in the management of these patients, who fall into the low-risk cardiovascular disease category, adjuvant to the main therapies. Registration code: IRCT20210125050 142N1.