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

NCT06778018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-11

No results posted yet for this study

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 9 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, 3 months (end of intervention), and follow-ups at 6 and 9 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.

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetic Nephropathies

Interventions

DIETARY_SUPPLEMENT

Lotus Seed

Regimen supplemented with 200 mg/kg of Lotus Seed capsules for 9-month randomized controlled trial.

DIETARY_SUPPLEMENT

Placebo

Regimen supplemented with 200 mg/kg of Starch capsules for 9-month randomized controlled trial.

Sponsors & Collaborators

  • Riphah International University

    lead OTHER

Principal Investigators

  • Moha Akram Khan, PhD* · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2026-02-10
Completion
2026-04-07

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06778018 on ClinicalTrials.gov