Description

The research project aims to investigate the therapeutic impact of Lotus Seed (Nelumbo nucifera) on Diabetic Sensorimotor Polyneuropathy (DSPN), a common complication observed in patients with type 1 and type 2 diabetes. DSPN is caused by chronic hyperglycemia, which leads to the degeneration of sensory and motor nerves, particularly the long peripheral nerves that extend to the arms, hands, legs, and feet. This damage results in pain, tingling, numbness, and loss of motor control. Additionally, DSPN can affect the functioning of the digestive system, urinary tract, blood vessels, and cardiovascular system. Over time, it serves as a precursor to more severe complications such as non-healing diabetic wounds, infections, diabetic foot ulcers, amputations, and, in extreme cases, death. The resulting neurological dysfunctions significantly reduce the quality of life for diabetic patients.

Conventional management of DSPN emphasizes glycemic control, symptom relief, and the prevention of long-term complications. Treatment options typically include medications for pain relief, such as neuropathic pain medications, alongside lifestyle changes and regular health monitoring. However, emerging research suggests that functional foods with neuroprotective properties, such as Lotus Seed, may offer an alternative or complementary approach. Histological studies indicate that Lotus exhibits neuroprotective and regenerative effects on nerve cells by inhibiting cellular apoptosis, especially during the acute injury phase. It has also been found to support axonal regeneration, reduce axonal dieback, and enhance motor function recovery. Additionally, Lotus overexpression has been shown to improve neuronal plasticity in the brainstem and cervical spinal cord after stroke, demonstrating its potential for future therapeutic applications in nerve-related disorders.

This study will be a 12-month randomized controlled trial (RCT) conducted at a private hospital in Lahore, Pakistan, targeting patients with a confirmed diagnosis of type 2 diabetes mellitus (T2DM). The participants will be randomly assigned to one of two groups. Group A (Control group) will receive the standard antidiabetic regimen along with a placebo capsule, while Group B (Treatment group) will receive the same antidiabetic regimen supplemented with Lotus Seed capsules at a dose of 200 mg/kg. The intervention period will last for 6 months, followed by two post-intervention follow-ups at 9 and 12 months to monitor the sustainability of the treatment effects. Before enrollment, all participants will provide informed consent, and their baseline health status will be assessed through comprehensive testing.

The key parameters to be evaluated include both nutritional, biochemical, and electrophysiological markers. Nutritional impact will be measured through anthropometric indices (such as Body Mass Index), dietary intake assessments, and changes in overall nutritional status. Serum biochemical tests will analyze metabolic markers, including glycemic parameters (HbA1c), lipid profile, liver function, and renal function. Neurological assessments will include the Neuropathy Disability Score and an evaluation of immune-modulatory responses to track changes in nerve function. These tests will be conducted at four time points: baseline (pre-intervention), 6 months (end of intervention), 9 months (follow-up), and 12 months (final follow-up).

All collected data will be analyzed using SPSS version 25. Statistical analysis will focus on comparing changes in health outcomes between the control and treatment groups to determine the impact of Lotus Seed supplementation on DSPN management. This research aims to establish evidence for the use of Lotus Seed as a functional food that can complement standard medical treatment, promoting nerve regeneration, improving metabolic parameters, and enhancing the overall health and well-being of patients with type 2 diabetes.