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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

Effects of Delta-tocotrienol and Resveratrol Supplementation on Cardiometabolic Risk Factors, Biochemical Markers and microRNAs in Patients with Metabolic Syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2019/021
Enrollment
Unknown
Registered
2019-07-10
Start date
2019-07-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Interventions

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 s
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 duratio

Sponsors

AFIP / National University of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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: 5.6 mmol/ l

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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] 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] 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] 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] 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] 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] [] [] [] [] []

Countries

Pakistan

Contacts

Public ContactDr. Dilshad Ahmed Khan

Professor of Pathology

dakhan@cpsp.edu.pk0519270676

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026