Type 2 DiabetesPhase 2/3NCT00363233
The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus
A Phase 2/3 study testing flax lignans in people with Type 2 Diabetes and Hypercholesterolemia, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Type 2 Diabetes, Hypercholesterolemia
- What is being tested?
- flax lignans
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Mar 2006to Dec 2006
- 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 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed type 2 diabetes
- Age: 50-79 years old
- LDL-cholesterol more than 2.9 mmol/l
Who cannot join
- Current or previous (within 6 months) use of estrogen therapy
- Cancer
- Chronic gastrointestinal diseases
- Current use of antibiotics
- Any severe liver or renal diseases
- Systolic blood pressure more than 180 mmHg or phase 3 hypertension
- Any severe mental diseases
- Severe cardio- or cerebro-vascular diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Institute for Nutritional Sciences, Chinese Academy of Sciences; Huadong Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study
The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.
Read the detailed description
The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.
- Conditions
- Type 2 Diabetes, Hypercholesterolemia
- Being tested
- flax lignans
- Keywords
- type 2 diabetes, lignans, flaxseed, cholesterol
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flax lignansDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol at 3 months
Secondary outcomes (1)
LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startMar 2006
- Study completionDec 2006
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 Type 2 DiabetesStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Investigators
- Xu Lin, MD, PhD, Principal investigator, Institute for Nutritional Sciences, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363233
- Sponsor's protocol ID
- 04DZ14007
- Status last verified
- Jan 2007
- First submitted
- 10 Aug 2006
- Last updated
- 9 Jan 2007
- Results posted
- No
Publications
Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS One. 2007 Nov 7;2(11):e1148. doi: 10.1371/journal.pone.0001148.
PubMed 17987126
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Flax Lignans on Lipid Profile and Glucose Management in Type 2 Diabetes: a Randomized Double-Blind Cross-Over Study
- ClinicalTrials.gov ID
- NCT00363233
- Acronym / sponsor ID
- 04DZ14007
- Conditions
- Type 2 Diabetes, Hypercholesterolemia
- Keywords
- type 2 diabetes, lignans, flaxseed, cholesterol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- Mar 2006
- Study completion
- Dec 2006
- First posted
- 15 Aug 2006 (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 the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.
Detailed description
The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed type 2 diabetes
- Age: 50-79 years old
- LDL-cholesterol more than 2.9 mmol/l
Key exclusion criteria (8 listed)
- Current or previous (within 6 months) use of estrogen therapy
- Cancer
- Chronic gastrointestinal diseases
- Current use of antibiotics
- Any severe liver or renal diseases
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 |
|---|---|---|
| flax lignans | Drug | – |
Primary outcome
Total cholesterol at 3 months
1 secondary outcome
LDL and triglycerides at 3 months; Blood glucose and HbA1C at 3 months
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 9 Jan 2007.
- Derived from this study: PubMed 17987126Pan A, Sun J, Chen Y, Ye X, Li H, Yu Z, Wang Y, Gu W, Zhang X, Chen X, Demark-Wahnefried W, Liu Y, Lin X. Effects of a flaxseed-derived lignan supplement in type 2 diabetic patients: a randomized, double-blind, cross-over trial. PLoS One. 2007 Nov 7;2(11):e1148. doi: 10.1371/journal.pone.0001148.
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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 flax lignans in people with Type 2 Diabetes and Hypercholesterolemia, 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 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 9 Jan 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 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. 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?
Total cholesterol at 3 months. 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 NCT00363233, 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 9 Jan 2007.