Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-31 @ 9:38 PM
Study NCT ID:
NCT00422266
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
2007-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Food in Dyslipidemic Adults
Sponsor:
Centre for Chronic Disease Control, India
Organization:
Study Overview
Official Title:
Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Drink/Food on the Composite Risk Profile of Dyslipidemic Adults
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence of chronic degenerative diseases, especially cardiovascular disease (CVD), is high world over and especially in India. High blood cholesterol and triglyceride levels are known to be important risk factors for CVD. There is a strong body of evidence for the beneficial effects of plant sterols on blood total and LDL-cholesterol and omega-3 fatty acids from fish on blood triglycerides. However, the combined benefits of consuming both plant sterols and omega-3 fatty acids from fish oil on blood cholesterol and triglycerides has not been investigated previously, except in one study where the methodology used was not the most appropriate for testing such a combination. In addition, most studies on plant sterol efficacy realised so far were done in Western countries. The present study will investigate the efficacy of plant sterols and omega-3 fatty acids from fish oil on improving the cardiovascular risk profile of Indian adults with dyslipidemia.
It is expected that, after 4 weeks of intervention, men consuming both plant sterols and omega-3 fatty acids from fish oil will have a lower cardiovascular risk profile than men receiving only plant sterols or only fish oil or none of these dietary supplements.
It is expected that, after 4 weeks of intervention, men consuming both plant sterols and omega-3 fatty acids from fish oil will have a lower cardiovascular risk profile than men receiving only plant sterols or only fish oil or none of these dietary supplements.
Detailed Description:
This study has a double-blind, placebo-controlled, randomized parallel (2 x 2 factorial) design with 3 experimental treatments and one control treatment. A two week run-in period will be observed during which all subjects will be given placebos for plant sterols. Thereafter the subjects will be randomly allocated to the 4 treatment groups for the intervention period of 4 weeks and will undergo baseline assessment of blood lipids, inflammatory and coagulation markers, anthropometry, lifestyle and dietary habits. The intervention period will be closed by repeating measurements of lipids, inflammatory and coagulation markers, anthropometry, lifestyle and diet. Participants are mildly hypercholesterolemic adult males (TC between 5.0-8.0 mmol/L), aged between 35-55 years who are employees of NTPC, Badarpur, New Delhi will be enrolled in the study.
The subjects will be randomly allocated to the four treatment groups (1 control and 3 experimental, 50 subjects per group) with the help of computer generated random number tables. In case of a surplus of volunteers, a lottery method of selection will be applied.
The active and control products will be almost identical with respect to taste and appearance and will only differ in coding. During the study, the treatment code of the products will be blinded and only known by a person not directly involved in the study. The subjects will only be identified by a unique identification code given to them at the time of filling their interview-schedules. All the information obtained from the subjects will be coded using this unique identification code. During the intervention period the key linking subject's names and codes will only be accessible to authorized staff.
For each subject the Investigator and Sponsor will each receive a blinded code envelope with details of treatment. In case of an emergency (e.g. Serious Adverse Event possibly related to treatments, or unexpected Adverse Events), the envelope can be opened to identify the treatment given to a subject. The Investigator and Sponsor will immediately inform each other about such de-blinding.
Randomization data are kept strictly confidential until the time of unblinding. Only after the blind review meeting of PI, Investigator and Sponsor, the randomization codes will be broken and made available for data analysis.
The subjects will be randomly allocated to the four treatment groups (1 control and 3 experimental, 50 subjects per group) with the help of computer generated random number tables. In case of a surplus of volunteers, a lottery method of selection will be applied.
The active and control products will be almost identical with respect to taste and appearance and will only differ in coding. During the study, the treatment code of the products will be blinded and only known by a person not directly involved in the study. The subjects will only be identified by a unique identification code given to them at the time of filling their interview-schedules. All the information obtained from the subjects will be coded using this unique identification code. During the intervention period the key linking subject's names and codes will only be accessible to authorized staff.
For each subject the Investigator and Sponsor will each receive a blinded code envelope with details of treatment. In case of an emergency (e.g. Serious Adverse Event possibly related to treatments, or unexpected Adverse Events), the envelope can be opened to identify the treatment given to a subject. The Investigator and Sponsor will immediately inform each other about such de-blinding.
Randomization data are kept strictly confidential until the time of unblinding. Only after the blind review meeting of PI, Investigator and Sponsor, the randomization codes will be broken and made available for data analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: