Nutritional Outcomes of Lotus Seed (Nelumbo Nucifera) on Diabetic Sensorimotor Polyneuropathy

Summary

The study focuses on Diabetic Sensorimotor Polyneuropathy (DSPN), a common complication of type 1 and type 2 diabetes caused by hyperglycemia-induced nerve damage, leading to pain, numbness, and motor dysfunction in the limbs. It also affects the digestive system, urinary tract, and cardiovascular health, often resulting in diabetic foot ulcers, amputations, and reduced quality of life. Current management involves glycemic control, pain relief, and complication prevention. Recent research highlights the neuroprotective potential of Lotus (Nelumbo nucifera) in promoting axonal regeneration, suppressing apoptosis, and enhancing motor function recovery. This randomized controlled trial will investigate the anti-diabetic effects of Lotus Seed in type 2 diabetes patients at a private hospital in Lahore, Pakistan, over 12 months. Participants will be divided into a control group receiving a standard antidiabetic regimen with placebo capsules and a treatment group receiving 200 mg/kg of Lotus Seed capsules alongside the antidiabetic regimen. Baseline characteristics and post-intervention changes will be assessed through nutritional impact (BMI, dietary intake), serum biochemical tests (HbA1c, lipid profile, liver, and renal function), and electrophysiological tests (Neuropathy Disability Score and immune-modulatory tests). Data collection will occur at baseline, 6 months (end of intervention), and follow-ups at 9 and 12 months. SPSS version 25 will be used for statistical analysis to evaluate the potential of Lotus Seed as a functional food for managing DSPN and improving health outcomes in diabetic patients.

Eligibility

Inclusion Criteria:

* Participants who have been clinically diagnosed with T2DM (Type 2 Diabetes Mellitus).
* Participants who have been clinically diagnosed with neuropathy symptoms for at least 1 year.
* Both male and female participants.
* Participants aged 40 years and older.
* Participants capable of understanding basic instructions, either independently or with assistance from their family.

Exclusion Criteria:

* Individuals with a clinical diagnosis of cardiovascular conditions.
* Cancer patients will be excluded from the study.
* Individuals diagnosed with rheumatoid arthritis.
* Individuals with a urinary tract infection.
* Individuals diagnosed with psychological disorders.
* Pregnant or breastfeeding women.

Conditions3

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