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

NCT06778018 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/24/1301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Keywords

Diabetic Sensorimotor Polyneuropathy; Lotus Seed; Electrophysiological; Neuroprotective; Type 2 Diabetes; Nutritional

Outcome Measures

Primary Outcomes (19)

• Body Mass Index (BMI)

  The Body Mass Index (BMI) will be calculated based on an individual's height and weight. Height will be measured using a stadiometer, and weight will be assessed with a weighing scale. BMI will be derived by dividing the weight in kilograms by the square of the height in meters. The classification thresholds established by the World Health Organization (WHO) will be utilized for interpretation.

  12 months

• HbA1c

  The HbA1c level of 6.5% will be measured by drawing blood from the individuals, followed by analysis to detect the presence of diabetes.

  12 months

• Lipid Profile

  A blood lipid profile will be collected from the individuals, and the analysis will be performed at the Private Hospital. The lipid profile will assess total cholesterol, very low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride levels.

  12 months

• Alanine Transaminase (ALT)

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure alanine transaminase (ALT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Liver Function Test-aspartate transaminase (AST)

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure aspartate transaminase (AST). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Liver Function Test-alkaline phosphatase (ALP)

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure alkaline phosphatase (ALP). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Liver Function Test-gamma-glutamyl transferase (GGT)

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure gamma-glutamyl transferase (GGT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Liver Function Test-serum bilirubin

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure serum bilirubin. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Liver Function Test-prothrombin time (PT)

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure prothrombin time (PT). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Liver Function Test-international normalized ratio (INR)

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure international normalized ratio (INR). The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Liver Function Test-total protein

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure total protein. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Liver Function Test-albumin

  Liver function tests will be performed by collecting blood from the individuals, and the analysis will take place at the Private Hospital. These tests will measure albumin. The tests will be conducted using semi-automatic or fully automated machines that operate on photometric principles.

  12 months

• Renal Function Test-serum creatinine

  Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like serum creatinine. Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.

  12 months

• Renal Function Test-blood urea nitrogen (BUN)

  Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like blood urea nitrogen (BUN). Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.

  12 months

• Renal Function Test- glomerular filtration rate (GFR)

  Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like glomerular filtration rate (GFR). Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.

  12 months

• Renal Function Test-electrolytes such as sodium, potassium, and chloride

  Renal function tests will be carried out by drawing blood from the individuals, and the analysis will be conducted at a private hospital. These tests will assess various markers of kidney function like electrolytes such as sodium, potassium, and chloride. Based on photometric principles, the tests will be performed using semi-automatic or fully automated analyzers.

  12 months

• Neuropathy disability score (NDS)

  The Neuropathy Disability Score (NDS) is a widely used clinical tool to evaluate signs of neuropathy. This assessment focuses on four key signs of neuropathy: ankle reflex, vibration sensation, pinprick sensation, and temperature perception, all tested on both sides of the largest toes. The total possible score is 10, with scores above 6 typically indicating an abnormal result.

  12 months

• Cell mediated Response CD4, CD3 and CD8.

  The patient's immune response will be assessed by measuring CD4, CD3, and CD8 levels at the Private Hospital. CD4 cells are the predominant T cells in healthy individuals and play a crucial role in assisting B cells with antibody production and enhancing immune reactions to antigens. CD4 cell count is often used as an indicator of immune suppression, with lower levels suggesting a gradual decline in immune function.

  12 months

• Immunoglobulins

  The patient's immune function will be assessed by measuring the levels of IgA, IgG, and IgM antibodies. These antibodies are proteins that the immune system generates to combat harmful microorganisms such as bacteria and viruses. The immunoglobulin test can help determine if there are any issues with the immune system, as certain conditions may lead to an imbalance in antibody production. IgM antibodies are the first to be produced after the body is exposed to pathogens, providing temporary defense until other antibodies are formed. These antibodies are present in the blood and lymph. IgG antibodies play a key role in fighting bacterial and viral infections, while IgA antibodies protect the respiratory and digestive systems.

  12 months

Study Arms (2)

Group A (Control group)

PLACEBO COMPARATOR

This group will receive the placebo treatment (starch) 200 mg/kg capsules. Baseline assessments will be conducted before the intervention, followed by health evaluations at 6 months (end of intervention), 9 months, and 12 months (follow-up assessments). Comprehensive health assessments will include nutritional status (BMI, dietary intake), biochemical markers (HbA1c, lipid profile, liver, and kidney function), and electrophysiological tests (Neuropathy Disability Score and immune-modulatory response). The data collected will be analyzed using SPSS version 25, allowing for comparisons between pre- and post-intervention outcomes in both groups.

Dietary Supplement: Placebo

Group B (Treatment group)

EXPERIMENTAL

This group will receive the intervention treatment 200 mg/kg Lotus Seed capsules. Baseline assessments will be conducted before the intervention, followed by health evaluations at 6 months (end of intervention), 9 months, and 12 months (follow-up assessments). Comprehensive health assessments will include nutritional status (BMI, dietary intake), biochemical markers (HbA1c, lipid profile, liver, and kidney function), and electrophysiological tests (Neuropathy Disability Score and immune-modulatory response). The data collected will be analyzed using SPSS version 25, allowing for comparisons between pre- and post-intervention outcomes in both groups.

Dietary Supplement: Lotus Seed

Interventions

Lotus Seed DIETARY_SUPPLEMENT

Regimen supplemented with 200 mg/kg of Lotus Seed capsules for 12-month randomized controlled trial.

Group B (Treatment group)

Placebo DIETARY_SUPPLEMENT

Regimen supplemented with 200 mg/kg of Starch capsules for 12-month randomized controlled trial.

Group A (Control group)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international university

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 38264279 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Officials

• Moha Akram Khan, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

: Imran Amjad, PhD

CONTACT

+92 33224390125; imran.amjad@riphah.edu.pk

Muhammad Imran Hussain, PhD

CONTACT

+92 300 4478597; Imran.hussain@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 16, 2025
• Study Start: December 10, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 15, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)