DyslipidemiaPhase 3NCT00422266
Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Food in Dyslipidemic Adults
A Phase 3 study testing Omega 3 fatty acids and plant sterol enriched drink and Omega 3 fatty acids and plant sterols in people with Dyslipidemia, run by Centre for Chronic Disease Control, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Omega 3 fatty acids and plant sterol enriched drink and Omega 3 fatty acids and plant sterols
- Type of treatment
- Pill or oral medicine
- How many people
- 178 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2006to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects aged between 35-55 years.
- Total cholesterol (TC) between 5.0 - 8.0 mmol/L.
- Body Mass Index (BMI) is between 18-30 kg/m2.
- Willing to consume the intervention product.
- Willing to participate in the study and perform all measurements including. blood drawing, anthropometry, dietary assessment and questionnaires.
- Informed consent signed by subject.
Who cannot join
- Smokers (more than 10 cigarettes per day).
- Heavy drinker (more than 6 large pegs or 360 ml of 40% alcohol per week).
- Triglycerides > 4.0 mmol/L.
- Individuals with chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke, diabetes, chronic renal failure, gastrointestinal disease, metabolic diseases (eg. thyroid, pancreas) and people with a compromised GI function like after extensive bowel resections.
- Fasting blood glucose > 120mg/dl and glycosylated hemoglobin > 7.5%.
- Individuals on medication (e.g.: insulin, oral hypoglycemic drugs, beta blockers, steroids or lipid-lowering drugs) or dietary supplements known to alter lipid and/or glucose metabolism during the study, including plant sterol-enriched foods and fish oil supplements, or having used these substances in 3 months preceding the intervention period.
- Reported participation in another biomedical trial 3 months before the start of the study or during the study.
- Reported weight loss / gain (10% or more) during the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Drink/Food on the Composite Risk Profile of Dyslipidemic Adults
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.
Read the 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.
- Conditions
- Dyslipidemia
- Being tested
- Omega 3 fatty acids and plant sterol enriched drink, Omega 3 fatty acids and plant sterols
- Keywords
- Dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acids and plant sterol enriched drinkDrug
Omega 3 fatty acids and plant sterolsDietary supplement
Capsules and Yoghurt based minidrink
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in TC, LDL-C, HDL-C, Triglycerides, and Fasting blood glucose.
Secondary outcomes (1)
Changes in LDL particle size, apo B, CRP and fibrinogen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startDec 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Chronic Disease Control, India
- Sponsor type
- University, hospital or other
- Investigators
- Srinath Reddy, MD, DM, MSc,, Principal investigator, Centre for Chronic Disease Control, IndiaPrabhakaran Dorairaj, MD, DM, MSc, Principal investigator, Centre for Chronic Disease Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422266
- Sponsor's protocol ID
- CCDC-6980
- Status last verified
- Sep 2007
- First submitted
- 12 Jan 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Drink/Food on the Composite Risk Profile of Dyslipidemic Adults
- ClinicalTrials.gov ID
- NCT00422266
- Acronym / sponsor ID
- CCDC-6980
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Centre for Chronic Disease Control, IndiaUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male subjects aged between 35-55 years.
- Total cholesterol (TC) between 5.0 - 8.0 mmol/L.
- Body Mass Index (BMI) is between 18-30 kg/m2.
- Willing to consume the intervention product.
- Willing to participate in the study and perform all measurements including. blood drawing, anthropometry, dietary assessment and questionnaires.
Key exclusion criteria (8 listed)
- Smokers (more than 10 cigarettes per day).
- Heavy drinker (more than 6 large pegs or 360 ml of 40% alcohol per week).
- Triglycerides > 4.0 mmol/L.
- Individuals with chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke, diabetes, chronic renal failure, gastrointestinal disease, metabolic diseases (eg. thyroid, pancreas) and people with a compromised GI function like after extensive bowel resections.
- Fasting blood glucose > 120mg/dl and glycosylated hemoglobin > 7.5%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 fatty acids and plant sterol enriched drink | Drug | – |
| Omega 3 fatty acids and plant sterolsCapsules and Yoghurt based minidrink | Dietary supplement | – |
Primary outcome
Changes in TC, LDL-C, HDL-C, Triglycerides, and Fasting blood glucose.
1 secondary outcome
Changes in LDL particle size, apo B, CRP and fibrinogen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinath Reddy, MD, DM, MSc, principal investigator
Centre for Chronic Disease Control, India
Prabhakaran Dorairaj, MD, DM, MSc principal investigator
Centre for Chronic Disease Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega 3 fatty acids and plant sterol enriched drink and Omega 3 fatty acids and plant sterols in people with Dyslipidemia, run by Centre for Chronic Disease Control, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in TC, LDL-C, HDL-C, Triglycerides, and Fasting blood glucose.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2007.