Assessment of Therapeutic Potential of Stigma Maydis (Cornsilk) on Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— cornsilk  

Official title:

Assessment of Therapeutic Potential of Stigma Maydis (Cornsilk) on Metabolic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240273
• Other study ID #: Silk syndrome
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: May 20, 2024

Study information

• Verified date: January 2024
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: Rija Jafar, Mphil
• Phone: 0302-4586616
• Email: rijajafar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 20, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Corn silk powder
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Veterinary and Animal Sciences, Lahore - Pakistan

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid profile will be assessed before and after the trial.	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
Primary	waist circumference will be measured before and after the trial.	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
Primary	Blood pressure will be assessed before and after the trial.	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
Primary	Fasting glucose level will be assessed before and after the trial.	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