Assessment of Therapeutic Potential of Stigma Maydis (Cornsilk) on Metabolic Syndrome (cornsilk)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Over the past two decades, there has been an increase in the number of people with nutrition related maladies due to changes in their dietary habits and lifestyle. Cardiovascular disease, type 2 diabetes, metabolic syndrome, obesity, and cancer have emerged as prominent contributors to both illness and death, particularly as the population continues to age. The mortality figures for cardiovascular disease and diabetes varied between 179.8 to 765.2 per 100,000 individuals, with the most elevated rates observed in poor nations. The occurrence of metabolic syndrome was markedly prevalent, spanning from 19% to 45%. The incidence of overweight and obesity (defined by a body mass index ≥25 kg/m2) has surged to concerning levels across many countries in the region, ranging from 25% to 82%, with a higher occurrence among women. Due to side effects of allopathic treatments and increase in nutrition knowledge people are more inclined to natural therapies. Subsequently, corn silk with nutraceutical properties may provide an effective alternative therapy to alleviate symptoms and decrease healthcare loss. Cornsilk, the often-overlooked byproduct of maize cultivation, is rich in bioactive compounds, including flavonoids, polysaccharides, and vitamins, cornsilk has shown promising effects in promoting health and wellness.
Hypothesis: Stigma maydis (corn silk) has a potential to manage metabolic syndrome.
Objective: To assess the therapeutic effect of Stigma maydis (corn silk) against metabolic syndrome.
Methodology: Cornsilk powder will be procured from a local market. The proximate analysis and total phenolic content of the product will be performed and then capsules of powder will be prepared to be consumed by the participants. A total of 40 subjects (20 in treatment group and 20 in control group) will be selected and capsules will be added to their diets (1000mg twice a day). After a trial of 45 days, the patients will be assessed. Assessment will include anthropometric measurements, blood pressure, lipid profile analysis and blood sugar levels which will be monitored before and after the trial and finally, the data collected will be analyzed by using SPSS 25 by paired sample t test. P value ≤ 0.05 will be considered significant.
Expected outcomes: Stigma maydis (corn silk) capsules will prove to have therapeutic potential against obesity, hypertension, glucose intolerance and dyslipidemia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rija Jafar, Mphil
- Phone Number: 0302-4586616
- Email: rijajafar@gmail.com
Study Contact Backup
- Name: Dr. M. Asif Ali, PhD
- Phone Number: 296 042-99211374
- Email: asif.ali@uvas.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Waist Circumference of ≥40 inches in males and ≥35 inches for females
- Subjects having fasting total cholesterol level of ≥ 200 mg/dl or LDL cholesterol ≥ 130 mg/dl.
- Fasting Blood Glucose ≥110mg/dl.
- SBP ≥ 130/ ≥ 85 mmHg
Exclusion Criteria:
- Participants aged 55 or above • Participants who have less than two risk factors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metabolic Syndrome patients
Cornsilk (Stigma maydis) is used for preventing symptoms of metabolic syndrome patients Dietary Intervention: Cornsilk Extract Dosage: 2g/day
|
Corn silk (CS) is abundant in phenolic compounds, especially flavonoids.
It also contains proteins, vitamins, carbohydrates, calcium, potassium, magnesium, sodium salts, volatile oils, sterols like sitosterol and stigmasterol, alkaloids, and saponins.
Numerous studies have explored the pharmacological activities associated with CS.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipid profile will be assessed before and after the trial.
Time Frame: 45 days
|
The change in lipid profile, after 45 days intervention of corn silk extract, will be assessed.
The value will be closed to optimized values.
|
45 days
|
|
waist circumference will be measured before and after the trial.
Time Frame: 45 days
|
the change in weight will be measured after 45 days of corn silk extract intervention.
The value will be close to normal ranges.
|
45 days
|
|
Blood pressure will be assessed before and after the trial.
Time Frame: 45 days
|
The change in systolic and diastolic blood pressure will be measured after 45 days intervention of corn silk extract.
The values will become close to optimized levels.
|
45 days
|
|
Fasting glucose level will be assessed before and after the trial.
Time Frame: 45 days
|
The change in fasting glucose levels will be assessed after 45 days intervention of corn silk extract powder.
The values will be become close to optimized levels
|
45 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr. M. Asif Ali, PhD, University of Veterinary and Animal Sciences, Lahore
Publications and helpful links
General Publications
- Shahzad MK, Amir Shahzad M, Qadeer U, Mehmood A. Investigation of phytochemical profiling and therapeutic effects of corn silk against diabetes in human male subjects. Pak J Pharm Sci. 2022 Nov;35(6(Special)):1699-1703.
- Shi S, Yu B, Li W, Shan J, Ma T. Corn silk decoction for blood lipid in patients with angina pectoris: A systematic review and meta-analysis. Phytother Res. 2019 Nov;33(11):2862-2869. doi: 10.1002/ptr.6474. Epub 2019 Aug 18.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Silk syndrome
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.