The role of Liposomal Vitamin C in metabolic syndrome patients

Not Applicable

• Conditions: Health Condition 1: null- Metabolic syndrome

• Registration Number: CTRI/2017/06/008906
• Lead Sponsor: CureSupport

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. 18 years of age and above

2. Metabolic abnormalities with or without alcohol consumption and/or smoking

3. Diagnosis of MetS ie. the presence of three or more criteria of the modified National Cholesterol Education Programs Adult Treatment Panel III ( NCEP ATP III:

3.1 Waist circumference 90 cm in men and 80 cm in women

3.2 Hypertriglyceridemia >= 150 mg/dl

3.3 High density lipoprotein (HDL) cholesterol 40 mg/dl in males and 50 mg/dl in females

3.4 Blood pressure >= 130/85 mm Hg

3.5 Fasting plasma glucose >= 110 mg/dl

3.6 Patients willing to provide written informed consent

Exclusion Criteria

1. Acute illness within the past 2 weeks

2. Pregnancy or breastfeeding

3. Lack of compliance with the study medication (defined as not using the medication for >1 week)

4. Documented intolerability to vitamin C

5. Participation in a concomitant trial

6. Hypersensitivity to the study medication

7. Regularly used nonsteroidal anti-inflammatory drugs (naproxen and cyclooxygenase-2 inhibitors) and/or cholesterol-lowering agents (statins)

8. Suffered from systemic and inflammatory diseases that change physical or laboratory tests (arthritis, renal, thyroid, hepatic, respiratory, gout, active malignant disease)

9. Impossibility to give informed consent

10. Intake of drugs or dietary supplements

11. Previous illnesses such as heart attack, cancer or dementia

12. Addiction illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune markers assessment: IgA, IgG and IgM <br/ ><br>Inflammatory marker C-reactive protein (CRP)Timepoint: Baseline and Week 8

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose, Body weight, anthropometric assessments, Systolic blood pressure, Diastolic blood pressure, <br/ ><br>Hematology and Biochemistry <br/ ><br>Quality of life using SF-36 questionnaireTimepoint: Baseline and at 8 weeks