Clinical trial NCT06778018: Nutritional Outcomes of Lotus Seed (Nelumbo Nucifera) on Diabetic Sensorimotor Polyneuropathy
Official title: Effects of Lotus Seed (Nelumbo Nucifera) on the Nutritional, Electrophysiological and Immunomodulatory Outcomes in Patients With Diabetic Sensorimotor Polyneuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetic Nephropathies
Keywords: Diabetic Sensorimotor Polyneuropathy
Lotus Seed
Electrophysiological
Neuroprotective
Type 2 Diabetes
Nutritional
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: it will be a randomized controlled trial in which non probability convenient sampling will be used. Two groups of 40 and above age will be formed in which participants will be randomly divided. Group A (Control group) will receive the standard antidiabetic regimen along with a placebo capsules (Starch) at the dose rate of 200mg/kg. , while Group B (Treatment group) will receive the same antidiabetic regimen supplemented with Lotus Seed capsules at a dose of 200 mg/kg.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 months
measure: Lipid Profile
timeFrame: 12 months
measure: Alanine Transaminase (ALT)
timeFrame: 12 months
measure: Liver Function Test-aspartate transaminase (AST)
timeFrame: 12 months
measure: Liver Function Test-alkaline phosphatase (ALP)
timeFrame: 12 months
measure: Liver Function Test-gamma-glutamyl transferase (GGT)
timeFrame: 12 months
measure: Liver Function Test-serum bilirubin
timeFrame: 12 months
measure: Liver Function Test-prothrombin time (PT)
timeFrame: 12 months
measure: Liver Function Test-international normalized ratio (INR)
timeFrame: 12 months
measure: Liver Function Test-total protein
timeFrame: 12 months
measure: Liver Function Test-albumin
timeFrame: 12 months
measure: Renal Function Test-serum creatinine
timeFrame: 12 months
measure: Renal Function Test-blood urea nitrogen (BUN)
timeFrame: 12 months
measure: Renal Function Test- glomerular filtration rate (GFR)
timeFrame: 12 months
measure: Renal Function Test-electrolytes such as sodium, potassium, and chloride
timeFrame: 12 months
measure: Neuropathy disability score (NDS)
timeFrame: 12 months
measure: Cell mediated Response CD4, CD3 and CD8.
timeFrame: 12 months
measure: Immunoglobulins
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Riphah International University
name: Moha Akram Khan, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu J, Hu Z, Luo Y, Liu Y, Luo W, Du X, Luo Z, Hu J, Peng S. Diabetic peripheral neuropathy: pathogenetic mechanisms and treatment. Front Endocrinol (Lausanne). 2024 Jan 9;14:1265372. doi: 10.3389/fendo.2023.1265372. eCollection 2023.