NCT05604300

Brief Summary

The objective of this study is to evaluate the effect of vitamin E incorporated oat supplementation among the metabolic syndrome (MetS) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

October 27, 2022

Last Update Submit

December 6, 2023

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (5)

  • Change in Triacylglycerol concentrations

    Triacylglycerol concentration is measured in mg/dL

    Baseline and 12 weeks

  • Change in HDL-cholesterol concentrations

    HDL-cholesterol concentration is measured in mg/dL

    Baseline and 12 weeks

  • Change in fasting blood glucose concentrations

    Fasting blood glucose concentration is measured in mg/dL

    Baseline and 12 weeks

  • Change in systolic and diastolic blood pressure

    Systolic and diastolic blood pressure are measured in mmHg

    Baseline and 12 weeks

  • Change in waist circumference

    Waist circumference is measured in cm

    Baseline and 12 weeks

Study Arms (3)

Vitamin E incorporated oat

ACTIVE COMPARATOR

Oral vitamin E incorporated oat supplementation

Dietary Supplement: Vitamin E incorporated oat supplement

Placebo

PLACEBO COMPARATOR

Oral oat supplementation

Dietary Supplement: Oat supplement

Control

NO INTERVENTION

Control

Interventions

Vitamin E incorporated oat supplementDIETARY_SUPPLEMENT

A twice daily supplementation of Vitamin E incorporated oat for 12 weeks

Vitamin E incorporated oat
Oat supplementDIETARY_SUPPLEMENT

A twice daily supplementation of oat for 12 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years old and above
  • Individuals who have been identified as having metabolic syndrome (meet ≥3 out of 5 NCEP-ATP III Criteria)
  • Stable weight (± 2 kg during the past 3months) to ensure reliable weight changes with the treatment given.
  • Not taking antioxidant/anti-inflammatory supplements (Example of antioxidant: vitamin C, vitamin E, grape seed extract, garlic capsule, ginkgo biloba); (Example of the anti-inflammatory supplement: fish oil, curcumin extract, ginger extract, spirulina)

You may not qualify if:

  • Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders
  • Cancer (all types) and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism).
  • Alcohol and drug abuse (self-mentioned or as recorded in the medical card)
  • Hormone replacement therapy (for at least three months prior to entering the study)
  • Use of steroids, chemotherapy, immunosuppressant, or radiotherapy
  • Currently pregnant or lactating
  • Participations currently under another supplementary program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Medical and Dental Institute (AMDI)

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lai Kuan Lee, PhD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 3, 2022

Study Start

June 1, 2022

Primary Completion

June 30, 2023

Study Completion

November 30, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)