NCT06240273

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 17, 2024

Last Update Submit

January 31, 2024

Conditions

Keywords

Metabolic SyndromeHypertensionObesityInsulin ResistanceDiabetesCornsilk powderDyslipidemia

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Metabolic Syndrome patients

EXPERIMENTAL

Cornsilk (Stigma maydis) is used for preventing symptoms of metabolic syndrome patients Dietary Intervention: Cornsilk Extract Dosage: 2g/day

Dietary Supplement: Corn silk powder

Interventions

Corn silk powderDIETARY_SUPPLEMENT

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.

Also known as: stigma maydis
Metabolic Syndrome patients

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Participants aged 55 or above • Participants who have less than two risk factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 36861231BACKGROUND
  • 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.

    PMID: 31423665BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeHypertensionObesityInsulin ResistanceDiabetes MellitusDyslipidemias

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine System DiseasesLipid Metabolism Disorders

Study Officials

  • Dr. M. Asif Ali, PhD

    University of Veterinary and Animal Sciences, lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rija Jafar, Mphil

CONTACT

Dr. M. Asif Ali, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
None (open-label) Participants Groups
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single group Assignment Case-control Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 5, 2024

Study Start

February 20, 2024

Primary Completion

April 20, 2024

Study Completion

May 20, 2024

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share