Metabolic SyndromecornsilkNCT06240273
Assessment of Therapeutic Potential of Stigma Maydis (Cornsilk) on Metabolic Syndrome
A study testing Corn silk powder in people with Metabolic Syndrome, run by University of Veterinary and Animal Sciences, Lahore - Pakistan.
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… Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Corn silk powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2024to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Participants aged 55 or above • Participants who have less than two risk factors
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Corn silk powder
- Keywords
- Metabolic Syndrome, Hypertension, Obesity, Insulin Resistance, Diabetes, Cornsilk powder, Dyslipidemia
- Medical subject headings
- Metabolic Syndrome, Hypertension, Obesity, Insulin Resistance, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn silk powderDietary supplement
Also called stigma maydis
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.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Syndrome patients | Experimental | Cornsilk (Stigma maydis) is used for preventing symptoms of metabolic syndrome patients Dietary Intervention: Cornsilk Extract Dosage: 2g/day Receives: Dietary Supplement: Corn silk powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 days
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.
Measured: 45 days
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.
Measured: 45 days
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
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion20 Apr 2024 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group Assignment Case-control Study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. M. Asif Ali, PhD, Principal investigator, University of Veterinary and Animal Sciences, lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240273
- Sponsor's protocol ID
- Silk syndrome
- Acronym
- cornsilk
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36861231Shi 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.
PubMed 31423665
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Therapeutic Potential of Stigma Maydis (Cornsilk) on Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06240273
- Acronym / sponsor ID
- cornsilk / Silk syndrome
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Hypertension, Obesity, Insulin Resistance, Diabetes, Cornsilk powder, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group Assignment Case-control Study
| Arm | Type | Receives |
|---|---|---|
| Metabolic Syndrome patients | Experimental | Dietary Supplement: Corn silk powderCornsilk (Stigma maydis) is used for preventing symptoms of metabolic syndrome patients Dietary Intervention: Cornsilk Extract Dosage: 2g/day |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participants aged 55 or above • Participants who have less than two risk factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corn silk powderAlso: stigma maydisCorn 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. | Dietary supplement | Metabolic Syndrome patients |
Primary outcome
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.
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 36861231Shahzad 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.
- Background: PubMed 31423665Shi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. M. Asif Ali, PhD principal investigator
University of Veterinary and Animal Sciences, lahore
Questions about this trial
What is this clinical trial studying?
A study testing Corn silk powder in people with Metabolic Syndrome, run by University of Veterinary and Animal Sciences, Lahore - Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rija Jafar, Mphil (0302-4586616, rijajafar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile will be assessed before and after the trial. (time frame: 45 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06240273, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.