Chronomedicine Insights: Evaluating the Impact of Time-Restricted Meal Intake on Lipid Profile Parameters Among Individuals With Type 2 Diabetes in Northern India.

INTRODUCTION: Time-restricted meal intake (TRM) has shown potential benefits such as enhanced insulin sensitivity, lowered blood sugar levels, and possible weight loss in individuals with type 2 diabetes mellitus (T2DM). Our study aimed to investigate the impact of TRM on lipid profile parameters such as total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and very low-density lipoprotein (VLDL) in fasting conditions in T2DM patients.

METHODS: In total, 400 patients from the endocrinology department at King George's Medical University (KGMU), Lucknow were enrolled in this study, adhering to the guidelines of the American Diabetes Association (ADA). Male and female patients with recently diagnosed T2DM (in the past five years), aged between 25 to 60 years, on oral anti-diabetic therapy excluding insulin, expressing willingness to provide written consent and to adhere to TRM were included in the TRM group. It was a longitudinal study as diabetic dyslipidemia is primarily caused by insulin resistance and nutritional reasons and we wanted to assess the effect of TRM on lipid profile in T2DM patients. Patients were enrolled via simple random sampling using the random number table method (computerized). The TRM group had an early dinner at 7 pm whereas the control group was of non-TRM/late-night eaters. TRM group was given comprehensive guidance including strategies to manage hunger, permissible beverage options (water and prescribed medication) during the fasting period, and daily maintenance of a diary documenting their timing, type, and quantity of food intake which they were requested to bring fortnightly. Emphasis was placed on recording even minor dietary items consumed throughout the day. The TRM group consumed food ad libitum during a 12-hour eating window from breakfast at 7 am to dinner at 7 pm. Data distribution was non-parametric. Mann-Whitney U test compared TRM and control group using mean values at baseline and follow-ups. Analysis used GraphPad Prism 9.2.0 software (GraphPad Inc., La Jolla, CA). A p-value less than 0.05 (p < 0.05) was considered statistically significant.

RESULTS: A total of 127 patients were lost to follow-up, resulting in 273 patients who completed the study. The mean value of TC in the TRM and non-TRM groups using the Mann-Whitney U test registered a highly significant p-value <0.0001 at 18 months, with a decrease of 14.17% from baseline in the TRM group and a decrease of 1.53% from baseline in the non-TRM group. The TRM group had a decrease of 24.75% in TG from a baseline value of 145.4±41.9, whereas the non-TRM group showed a decrease of 2.2% from a baseline value of 154.7±37.30 (p-value <0.0001). The TRM group showed an increase of 9.25% in HDL from a baseline value of 50.14±8.58; the non-TRM group showed an increase of 0.82% from a baseline value of 48.62±9.31 (p-value <0.0001). TRM group showed a decrease of 8.62% in LDL from a baseline value of 68.20±16.2 while the non-TRM group showed an increase of 1.54% from a baseline value of 65.38±19.3 (p-value <0.0002). The TRM group showed a decrease of 13.97% in VLDL from a baseline value of 32.20±18.7; the non-TRM group showed an increase of 4% from a baseline value of 30.16±24.2 (p-value <0.0001).

CONCLUSION: Our study's promising results underscore the potential of TRM as an effective strategy for managing dyslipidemia in individuals with T2DM, even over prolonged periods.