Home » Trials » SLCTR/2019/021
Effects of Delta-tocotrienol and Resveratrol Supplementation on Cardiometabolic Risk Factors, Biochemical Markers and microRNAs in Patients with Metabolic Syndrome
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SLCTR Registration Number
SLCTR/2019/021
Date of Registration
The date of last modification
Sep 15, 2020
Scientific Title of Trial
Effects of Delta-tocotrienol and Resveratrol Supplementation on Cardiometabolic Risk Factors, Biochemical Markers and microRNAs in Patients with Metabolic Syndrome
Public Title of Trial
Comparing the efficacy of Delta-Tocotrienol and resveratrol mixture vs placebo on reducing the cardiometabolic risk and associated biochemical markers in patients with Metabolic Syndrome – A Randomized Controlled Trial
Disease or Health Condition(s) Studied
Metabolic Syndrome
Scientific Acronym
None
Public Acronym
None
Brief title
Effects of Delta-tocotrienol and resveratrol supplementation on cardiometabolic risk factors and biochemical markers in patients with metabolic syndrome
Universal Trial Number
U1111-1233-8736
Any other number(s) assigned to the trial and issuing authority
Cons-CHP-6/READ-IRB/19/179: ERC AFIP, Rawalpindi, Pakistan
What is the research question being addressed?
Is delta-tocotrienol and resveratrol mixture effective in improving cardiometabolic risk factors, biochemical markers and microRNAs in patients with metabolic syndrome?’
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Healthcare providers
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Study setting: This study will be conducted at Armed Forces Institutes of Pathology (AFIP), National University of Medical Sciences Rawalpindi, Pakistan.
Randomization: The patients with metabolic syndrome will be assigned to one of the two arms consisting of (A) intervention nutritional supplements (NS) and (B) control placebo (PS) arm by simple randomization.
Details of intervention: Patients in the NS arm will be assigned to receive nutritional supplement capsule (Delta-tocotrienol 250mg; Resveratrol 150mg) twice daily orally (one in the morning and one in the evening) for 24 weeks. Patients in PS arm will receive a matching placebo (cellulose 400 mg) for the same frequency and duration.
During the study period, participants in both arms will be requested to avoid consuming vitamin E, resveratrol or anti- inflammatory drugs.
Masking will be carried out as follows: Participants: Blinded Healthcare providers: Blinded
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
Improvement of metabolic syndrome parameters; including mean reduction in measurement of waist circumference (cm), serum triglyceride (mmol/L), fasting plasma glucose (mmol/L), blood pressure (mmHg) and increase HDL-cholesterol (mmol/L) at 24 weeks with baseline values. |
[ At the baseline of the study and at 24 weeks after supplementation of NS ] |
Secondary outcome(s)
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1.
Mean reduction in measurement of glycated Hb (mmol/L), serum insulin (IU/L) and Homeostatic Model Assessment for Insulin Resistance (HOMA IR |
[ At the baseline of the study and 24 weeks after supplementation of NS ] |
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2.
Mean reduction in measurement of serum total cholesterol (mmol/L), LDL- cholesterol (mmol/L), uric acid (mmol/L), alanine aminotransferase (IU/L) and Gamma-glutamyl transferase (IU/L) |
[ At the baseline of the study and 24 weeks after supplementation of NS ] |
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3.
Mean reduction in measurement of serum high sensitive C-reactive Protein (mg/l)), interleukin -6 (pg/ml) and tumour Necrosis Factor (pg/ml) |
[ At the baseline of the study and 24 weeks after supplementation of NS ] |
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4.
Mean reduction in measurement in oxidative stress marker i.e. serum malondialdehyde (ng/ml |
[ At the baseline of the study and 24 weeks after supplementation of NS ] |
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5.
Change in serum adiponectin and vascular cell adhesion molecules-1 (ng/ml) |
[ At the baseline of the study and 24 weeks after supplementation of NS ] |
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6.
Change in relative expression of circulatory micro-RNAs (miR-15b-5p, miR-130b-5p, miR-221-5p, miR-376b-5p and miR-122-5p) |
[ At the baseline of the study and 24 weeks after supplementation of NS ] |
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Target number/sample size
82(41 in each arm)
Countries of recruitment
Pakistan
Anticipated start date
2019-07-15
Anticipated end date
2020-02-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National University of Medical Sciences Rawalpindi, Pakistan.
Regulatory approvals
Status
Approved
Date of Approval
2019-02-20
Approval number
Cons-CHP-6/READ-IRB/19/179 : ERC AFIP, Rawalpindi, Pakistan.
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Armed Forces Institute of Pathology, NUMS Pakistan |
| Institutional Address: | READ Department Ethics Review Committee, Armed Forces Institute of Pathology, NUMS Pakistan |
| Telephone: | 92-51 5176397 |
| Email: | drsamreenfowad@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Dilshad Ahmed Khan
Professor of Pathology
National University of Medical Sciences (NUMS), Islamabad
0519270676
92-3005147938
dakhan@cpsp.edu.pk
Contact Person for Public Queries
Dr. Safia Fatima
PhD Scholar
Armed forces institute of Pathology (AFIP), National University of Medical Sciences (NUMS), Islamabad
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92-3320445444
safia.fatima@numspak.edu.pk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
