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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

Phase 2
Not yet recruiting
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
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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