Clinical trial NCT06240273: Assessment of Therapeutic Potential of Stigma Maydis (Cornsilk) on Metabolic Syndrome
Official title: Assessment of Therapeutic Potential of Stigma Maydis (Cornsilk) on Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Hypertension
Obesity
Insulin Resistance
Diabetes
Cornsilk powder
Dyslipidemia
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group Assignment Case-control Study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipid profile will be assessed before and after the trial.
timeFrame: 45 days
measure: waist circumference will be measured before and after the trial.
timeFrame: 45 days
measure: Blood pressure will be assessed before and after the trial.
timeFrame: 45 days
measure: Fasting glucose level will be assessed before and after the trial.
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Veterinary and Animal Sciences, lahore
name: Dr. M. Asif Ali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.