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
- Conditions
- Metabolic Syndrome
- Registration Number
- SLCTR/2019/021
- Lead Sponsor
- AFIP / National University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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]<br>
- Secondary Outcome Measures
Name Time Method