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

10 Jul 2019

The date of last modification

Jul 10, 2019



Application Summary


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


Trial Details


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

  1. Both men and women
  2. Aged 18-60 years
  3. Participants who are diagnosed to have metabolic syndrome according to International Diabetic Federation -2005 Criteria; (South Asian specific waist circumference cut-off (>90 cm in male and > 80 cm in female) plus any two of the following four cardiometabolic risk factors: a. Blood pressure: Systolic BP >130 or diastolic BP> 85 mmHg b. Triglyceride: >1.7 mmol/l c. HDL-cholesterol: <1.03 mmol/l in males and < 1.29 mmol/ l in females d. Fasting plasma glucose>5.6 mmol/ l

Exclusion criteria

  1. Women who are pregnant, lactating and/or in puerperium
  2. Patients with ischemic heart disease.
  3. Patients with diabetes mellitus (FBG> 7.0 mmol/l), hypertension (BP> 160/100 mmHg) or hypertriglyceridemia (Serum triglyceride > 5.65mmol/l)
  4. Patients of chronic inflammatory diseases, renal failure, hepatic or thyroid disorders
  5. Body Mass Index >40 kg/m2
  6. Patients using supplements containing antioxidants or anti-inflammatory drugs


Primary outcome(s)

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)

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

]
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

]
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

]
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

]
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

]
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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

AFIP / National University of Medical Sciences

Rawalpindi, Pakistan



Secondary study sponsor (If any)

None





Trial Completion details


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