Nigella sativa and Trigonella foenum-graecum Supplemented Chapatis Safely Improve HbA1c, Body Weight, Waist Circumference, Blood Lipids, and Fatty Liver in Overweight and Diabetic Subjects: A Twelve-Week Safety and Efficacy Study

Abstract

In 2019, * 463 million people globally had diabetes mellitus (DM), with China (25.1%), India (16.6%), and the United States (6.69%) representing nearly 50% of that total. The primary objectives of this exploratory study were to assess the safety and potential efficacy of Nigella sativa and fenugreek seed supplemented chapatis in overweight (OW) and type 2 DM subjects. Forty subjects (15/OW; 9/DM; 16/DM/OW) consumed two chapatis twice a day 6 days/week for a daily dose of 5.45 g of an N. sativa/fenugreek combination over 12 weeks with no changes in lifestyle or medications. Anthropometric, glycemic, and vascular variables were recorded at baseline and after 6 and 12 weeks. Glycated hemoglobin (HbA1c), plasma lipids, and complete metabolic profile were measured at baseline and termination. Compliance, estimated during twice-daily individual delivery of precooked chapatis, was 100%, with no significant adverse effects. At termination, body weights, body mass index, waist and hip circumferences, index of central obesity, HbA1c, fasting blood glucose, 2-h postprandial blood glucose, estimated average glucose over 12 weeks, total cholesterol (TC), non-high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL), and triglycerides (TG) were decreased (P < .05) over all subjects. Subjects with HbA1c ‡7.0 exhibited greater improvements in all glycemic variables than HbA1c <7.0 subjects. In addition, the decrease in HbA1c was positively correlated with decreases in (1) hepatic enzymes alkaline phosphatase (r = 0.301, P = .0067) and aspartate transaminase (r = 0.277, P = .0129), (2) systolic blood pressure (r = 0.388, P = .0004), and (3) number of diagnostic metabolic syndrome criteria exhibited per subject (r = 0.391, P = .0005), cardiovascular risk score (CRS) (r = 0.281, P = .0115), and hepatic steatosis index (HSI) (r = 0.223, P = .0467). Atherogenic and diabetogenic indexes TC/HDL, low density lipoprotein/HDL, VLDL/HDL, and TG/HDL were all decreased (P < .05). Among all subjects, improvement (P < .05) was seen in CRS (-10.7%), fatty liver index (-19.8%), lipid accumulation product (-13.8%), and HSI (-7.53%). N. sativa/fenugreek supplemented chapatis present a safe and seamless dietary modification to address cardiometabolic risk.

Effects of Nigella sativa, Camellia sinensis, and Allium sativum as Food Additives on Metabolic Disorders, a Literature Review

“…In a study, the impact of N. sativa (5.45 g/day) and fenugreek seed-supplemented chapatis in individuals with overweight and type 2 diabetes mellitus was appraised. In this study, BMI, fasting blood sugar, LDL, VLDL, and TG decreased in treated subjects (Rao et al, 2020). Administration of 2 g/day of N. sativa for 12 weeks has been shown to ameliorate dyslipidemia and to prevent the cardiovascular problem in patients with type 2 diabetes mellitus (Kaatabi et al, 2012).…”

The Effect of a Persian Herbal Medicine Compound on the Lipid Profiles of Patients with Dyslipidemia: A Randomized Double-Blind Placebo-Controlled Clinical Trial

“…The study mentioned above was performed under specific limitations. Particularly, it did not have a concurrent control group [ 42 ].…”

Nigella sativa L. Phytochemistry and Pharmacological Activities: A Review (2019–2021)

“…These obtained results were attributed to the different chemical compounds present such as linoleic acid and palmitic acid [ 36 ]. A study carried out on overweight, type 2 diabetes, and overweight + type 2 diabetes volunteers by a combination of black cumin seeds and fenugreek induced a decrease in glycated hemoglobin which correlated positively with a decrease in liver enzymes [ 102 ]. From the methanolic extract of the aerial part of NS , several chemical compounds were isolated and tested on intestinal α-glucosidase and phosphatase tyrosine kinase (PTP1B), which is considered a negative regulator in insulin signal transduction.…”

“…The supplementation of overweight, type 2 diabetes, and overweight + type 2 diabetes volunteers with a combination of black cumin seeds and fenugreek induced a decrease in LDL, TG, and VLDL and also atherogenicity index [ 102 ]. It was also mentioned that TQ was responsible for the decrease of total cholesterol, LDL, and also C-reactive proteins [ 92 ] ( Table 7 ).…”