Type 2 DiabetesPhase 3NCT00695526
Effects of Cranberry Extractive on the Lipid Profiles in Subjects With Type 2 Diabetes
A Phase 3 study testing cranberry in people with Type 2 Diabetes, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- cranberry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2006to Oct 2006
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetic subjects
- age between 50 and 75 years
Who cannot join
- glycosylated hemoglobin (HbA1c) less than 7% or more than 10%;
- triglyceride more than 4.5 mmol/L;
- current insulin treatment;
- change of the medications for anti-diabetes, hypertension, hyperlipidemia and anti-platelet in recent four weeks;
- abnormal renal function (serum creatinine > 177 μmol/L;
- abnormal liver function test results (more than two-fold upper limit of normal range);
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- severe systemic disease such as immune disorder, cancer, acute or chronic inflammation disease;
- smoking in recent 1 year;
- alcoholism (more than two drinks daily);
- using steroid or drugs with unknown components;
- pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, 407
About this study
Official title: Phase 3 Study of Cranberry on Lipid Profiles in Type 2 Diabetes
Cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs.
Read the detailed description
Hypercholesterolemia is a notorious risk factor for cardiovascular disease. It had been reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein (HDL) cholesterol levels in non-diabetic subjects. Although characteristics of diabetic dyslipidemia are low HDL and high triglyceride, the benefits of concentrated powder of cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet control alone. To the best of our knowledge, the effect of cranberry on lipid profiles in type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially total to HDL cholesterol ratio which is important in predicting cardiovascular diseases in Asian and/or diabetic population. Furthermore, cranberry has anti-oxidative effect which is associated with reduction of oxidized low-density lipoprotein (ox-LDL) cholesterol in non-diabetes. Therefore, we conducted a placebo-controlled, double-blind, randomized study to assess the effect of cranberry on lipid profiles in type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- cranberry
- Keywords
- cranberry, total to HDL cholesterol ratio, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranberryDietary supplement
cranberry extractive in powder product (by Triarco Industries, Inc. NJ, USA) and encapsulated in dose of 500mg/capsule (by Topo digital tech co., Taiwan). By one capsule after each of three meals per day.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Dietary Supplement: cranberry |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of total to HDL cholesterol ratio
Measured: 12 weeks
Secondary outcomes (6)
the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride)
Measured: 12 weeks
the change of ox-LDL
Measured: 12 weeks
the change of fasting plasma glucose
Measured: 12 weeks
the change of HbA1c
Measured: 12 weeks
the change of CRP
Measured: 12 weeks
the change of UAE
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 posted12 Jun 2008 (estimated)
- Study startMay 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- I Te Lee, MD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695526
- Sponsor's protocol ID
- C06066
- Status last verified
- Jun 2008
- First submitted
- 11 Apr 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Cranberry on Lipid Profiles in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00695526
- Acronym / sponsor ID
- C06066
- Conditions
- Type 2 Diabetes
- Keywords
- cranberry, total to HDL cholesterol ratio, type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Jun 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.
Cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs.
Detailed description
Hypercholesterolemia is a notorious risk factor for cardiovascular disease. It had been reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein (HDL) cholesterol levels in non-diabetic subjects. Although characteristics of diabetic dyslipidemia are low HDL and high triglyceride, the benefits of concentrated powder of cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet control alone. To the best of our knowledge, the effect of cranberry on lipid profiles in type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially total to HDL cholesterol ratio which is important in predicting cardiovascular diseases in Asian and/or diabetic population. Furthermore, cranberry has anti-oxidative effect which is associated with reduction of oxidized low-density lipoprotein (ox-LDL) cholesterol in non-diabetes. Therefore, we conducted a placebo-controlled, double-blind, randomized study to assess the effect of cranberry on lipid profiles in type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: cranberry |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetic subjects
- age between 50 and 75 years
Key exclusion criteria (11 listed)
- glycosylated hemoglobin (HbA1c) less than 7% or more than 10%;
- triglyceride more than 4.5 mmol/L;
- current insulin treatment;
- change of the medications for anti-diabetes, hypertension, hyperlipidemia and anti-platelet in recent four weeks;
- abnormal renal function (serum creatinine > 177 μmol/L;
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 |
|---|---|---|
| cranberrycranberry extractive in powder product (by Triarco Industries, Inc. NJ, USA) and encapsulated in dose of 500mg/capsule (by Topo digital tech co., Taiwan). By one capsule after each of three meals per day. | Dietary supplement | A |
Primary outcome
the change of total to HDL cholesterol ratio
Time frame: 12 weeks
6 secondary outcomes
the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride)
Time frame: 12 weeks
the change of ox-LDL
Time frame: 12 weeks
the change of fasting plasma glucose
Time frame: 12 weeks
the change of HbA1c
Time frame: 12 weeks
the change of CRP
Time frame: 12 weeks
the change of UAE
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 17 Jun 2008.
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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.
I Te Lee, MD principal investigator
Taichung Veterans General Hospital
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 cranberry in people with Type 2 Diabetes, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 inclusion and 11 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 17 Jun 2008. 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 Taiwan. 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?
the change of total to HDL cholesterol ratio (time frame: 12 weeks). 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 17 Jun 2008.