Metabolic Syndrome XPhase 2/3FIMSNCT00733772
Flaxseed Intervention on Metabolic Syndrome
A Phase 2/3 study testing flaxseed and Health lifestyle counseling in people with Metabolic Syndrome X, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is effective in the treatment of metabolic syndrome (MetS). Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- flaxseed and Health lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Dec 2009
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- with metabolic syndrome Metabolic syndrome was defined based upon the updated National Cholesterol Education Program Adult Treatment Panel III criteria for Asian-Americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) HDL cholesterol <1.03 for men or <1.30 for women; 4) blood pressure ≥130/85 mmHg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin. - Being able to comply with the specified feeding conditions
- Being able to eat flaxseeds
- Being between the ages of 35 and 60 years
Who cannot join
- Pregnancy or lactation
- Use of insulin
- Severe kidney disease
- Cardiovascular diseases, stroke, cancer and psychological disorders
- Flaxseed allergies or frequently eating flaxseeds or sesame (>90 grams/week)
- Drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, 200031
About this study
Official title: The Effects of Flaxseed Supplement on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is effective in the treatment of metabolic syndrome (MetS).
Read the detailed description
Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and CVD. It has become one of the major public health challenges in China due to rapidly nutrition transition and the nature of obesity epidemic. Treatment of MetS in China is very important for the prevention of the epidemic of its consequences (such as CVD and type 2 diabetes).
Compelling evidence from recent human studies has demonstrated that diet and lifestyle modifications are effective means in MetS management. Flaxseed is a complex food source containing high amounts of alpha-linolenic acid (ALA) - an omega-3 fatty acid - as well as fiber, lignan precursors and other substances that may have an impact on our health. Therefore, the aim of this study is to investigate the effect of flaxseed supplementation on the management of MetS in adult Chinese men and women in a randomized, controlled clinical trial. A total of 200 participants with MetS (defined by NCEP-ATPⅢ criteria) will be randomly assigned to a flaxseed-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. Effects of flaxseed supplementation will be evaluated by measuring metabolic profile (BMI, blood pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin, HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function (E-selectin, ICAM-1 and VCAM-1), and fatty acid profile.
- Conditions
- Metabolic Syndrome X
- Being tested
- flaxseed, Health lifestyle counseling
- Keywords
- flaxseed, lignans, alpha-Linolenic Acid, LDL Cholesterol
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flaxseedDietary supplement
30 grams/day of flaxseed for 12 weeks
Health lifestyle counselingBehavioural
Also called Health lifestyle counseling accroding to AHA reccommendation
Health lifestyle counseling accroding to AHA reccommendation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | healthy lifestyle counseling + 30 grams/day supplement of Flaxseed Receives: Dietary Supplement: flaxseed; Behavioral: Health lifestyle counseling |
| B | Sham comparator | TLC diet Receives: Behavioral: Health lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome status
Measured: 12 weeks
Secondary outcomes (1)
Total cholesterol, triglyceride, HDL-C,LDL-c, fasting glucose and insulin, HbA1C, blood pressure, CRP, IL-6, adiponectin, RBP-4, E-selectin, ICAM-1, VCAM-1, and fatty acid profiles of red blood cells.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xu Lin, Chinese Academy of Sciences
- Investigators
- Xu Lin, MD, PhD, Principal investigator, Institute for Nutritional Sciences, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733772
- Sponsor's protocol ID
- KSCX1-YW-02
- Acronym
- FIMS
- Status last verified
- Feb 2015
- First submitted
- 11 Aug 2008
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu H, Pan A, Yu Z, Qi Q, Lu L, Zhang G, Yu D, Zong G, Zhou Y, Chen X, Tang L, Feng Y, Zhou H, Chen X, Li H, Demark-Wahnefried W, Hu FB, Lin X. Lifestyle counseling and supplementation with flaxseed or walnuts influence the management of metabolic syndrome. J Nutr. 2010 Nov;140(11):1937-42. doi: 10.3945/jn.110.126300. Epub 2010 Sep 8.
PubMed 20826632
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Flaxseed Supplement on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00733772
- Acronym / sponsor ID
- FIMS / KSCX1-YW-02
- Conditions
- Metabolic Syndrome X
- Keywords
- flaxseed, lignans, alpha-Linolenic Acid, LDL Cholesterol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Aug 2008 (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 purpose of this study is to determine whether daily supplement of 30 grams flaxseed is effective in the treatment of metabolic syndrome (MetS).
Detailed description
Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and CVD. It has become one of the major public health challenges in China due to rapidly nutrition transition and the nature of obesity epidemic. Treatment of MetS in China is very important for the prevention of the epidemic of its consequences (such as CVD and type 2 diabetes).
Compelling evidence from recent human studies has demonstrated that diet and lifestyle modifications are effective means in MetS management. Flaxseed is a complex food source containing high amounts of alpha-linolenic acid (ALA) - an omega-3 fatty acid - as well as fiber, lignan precursors and other substances that may have an impact on our health. Therefore, the aim of this study is to investigate the effect of flaxseed supplementation on the management of MetS in adult Chinese men and women in a randomized, controlled clinical trial. A total of 200 participants with MetS (defined by NCEP-ATPⅢ criteria) will be randomly assigned to a flaxseed-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. Effects of flaxseed supplementation will be evaluated by measuring metabolic profile (BMI, blood pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin, HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function (E-selectin, ICAM-1 and VCAM-1), and fatty acid profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: flaxseed, Behavioral: Health lifestyle counselinghealthy lifestyle counseling + 30 grams/day supplement of Flaxseed |
| B | Sham comparator | Behavioral: Health lifestyle counselingTLC diet |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- with metabolic syndrome Metabolic syndrome was defined based upon the updated National Cholesterol Education Program Adult Treatment Panel III criteria for Asian-Americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) HDL cholesterol <1.03 for men or <1.30 for women; 4) blood pressure ≥130/85 mmHg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin. - Being able to comply with the specified feeding conditions
- Being able to eat flaxseeds
- Being between the ages of 35 and 60 years
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- Use of insulin
- Severe kidney disease
- Cardiovascular diseases, stroke, cancer and psychological disorders
- Flaxseed allergies or frequently eating flaxseeds or sesame (>90 grams/week)
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 |
|---|---|---|
| flaxseed30 grams/day of flaxseed for 12 weeks | Dietary supplement | A |
| Health lifestyle counselingAlso: Health lifestyle counseling accroding to AHA reccommendationHealth lifestyle counseling accroding to AHA reccommendation | Behavioural | A, B |
Primary outcome
Metabolic syndrome status
Time frame: 12 weeks
1 secondary outcome
Total cholesterol, triglyceride, HDL-C,LDL-c, fasting glucose and insulin, HbA1C, blood pressure, CRP, IL-6, adiponectin, RBP-4, E-selectin, ICAM-1, VCAM-1, and fatty acid profiles of red blood cells.
Time frame: 12 weeks
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 5 Feb 2015.
- Derived from this study: PubMed 20826632Wu H, Pan A, Yu Z, Qi Q, Lu L, Zhang G, Yu D, Zong G, Zhou Y, Chen X, Tang L, Feng Y, Zhou H, Chen X, Li H, Demark-Wahnefried W, Hu FB, Lin X. Lifestyle counseling and supplementation with flaxseed or walnuts influence the management of metabolic syndrome. J Nutr. 2010 Nov;140(11):1937-42. doi: 10.3945/jn.110.126300. Epub 2010 Sep 8.
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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.
Xu Lin, MD, PhD principal investigator
Institute for Nutritional Sciences, Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing flaxseed and Health lifestyle counseling in people with Metabolic Syndrome X, run by Chinese Academy of Sciences at 1 site in China.
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 3 inclusion and 6 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 5 Feb 2015. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Metabolic syndrome status (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733772, which also lists 1 linked publication.
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 5 Feb 2015.