Type 2 DiabetesPhase 4NCT03299153
The Effects of Barberry Juice Consumption in Patients With Type 2 Diabetes
A Phase 4 study testing barberry juice in people with Type 2 Diabetes, run by National Nutrition and Food Technology Institute.
Trial summary
The aim of this study was to investigate the effect of barberry juice (BJ) as a natural antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from "Diabetes Association of Iran-Babul ". Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- barberry juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 21 Dec 2016to 5 Aug 2017
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting blood glucose>100 mg/dL (5.6 mmol /L)
- Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg
- Triglycerides> 150 mg/dL (1.7 mmol/L)
Who cannot join
- taking insulin
- smoking
- using antioxidant supplements
About this study
Official title: The Effects of Barberry Juice Consumption on Glycaemic Control, Lipid Profile, Blood Pressure and Oxidative Stress in Patients With Type 2 Diabetes: A Randomized Clinical Trial
The aim of this study was to investigate the effect of barberry juice (BJ) as a natural antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from "Diabetes Association of Iran-Babul ". Patients were randomly allocated to either the BJ group (n=23) who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no intervention. At the baseline and the end of 8-week intervention, blood pressure and biochemical markers were conducted.
- Conditions
- Type 2 Diabetes
- Being tested
- barberry juice
- 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.
barberry juiceOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | patients in this group were received 200 ml/d barberry juice for tow month Receives: Other: barberry juice |
| control group | No intervention | patients in this group received no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose
Measured: 8 weeks
total cholesterol
Measured: 8 weeks
Secondary outcomes (6)
LDL- cholesterol
Measured: 8 weeks
HDL- cholesterol
Measured: 8 weeks
Triglyceride
Measured: 8 weeks
HbA1c
Measured: 8 weeks
Systolic BP
Measured: 8 weeks
Diastolic BP
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start21 Dec 2016
- Primary completion16 Apr 2017
- Study completion5 Aug 2017
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.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299153
- Sponsor's protocol ID
- 1534
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Barberry Juice Consumption on Glycaemic Control, Lipid Profile, Blood Pressure and Oxidative Stress in Patients With Type 2 Diabetes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03299153
- Acronym / sponsor ID
- 1534
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 16 Apr 2017 (actual)
- Study completion
- 5 Aug 2017 (actual)
- First posted
- 2 Oct 2017 (actual)
- 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 aim of this study was to investigate the effect of barberry juice (BJ) as a natural antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from "Diabetes Association of Iran-Babul ". Patients were randomly allocated to either the BJ group (n=23) who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no intervention. At the baseline and the end of 8-week intervention, blood pressure and biochemical markers were conducted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: barberry juicepatients in this group were received 200 ml/d barberry juice for tow month |
| control group | No intervention | –patients in this group received no intervention |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fasting blood glucose>100 mg/dL (5.6 mmol /L)
- Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg
- Triglycerides> 150 mg/dL (1.7 mmol/L)
Key exclusion criteria (3 listed)
- taking insulin
- smoking
- using antioxidant supplements
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 |
|---|---|---|
| barberry juice | Other | Intervention group |
Primary outcome
fasting blood glucose
Time frame: 8 weeks
total cholesterol
Time frame: 8 weeks
6 secondary outcomes
LDL- cholesterol
Time frame: 8 weeks
HDL- cholesterol
Time frame: 8 weeks
Triglyceride
Time frame: 8 weeks
HbA1c
Time frame: 8 weeks
Systolic BP
Time frame: 8 weeks
Diastolic BP
Time frame: 8 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 2 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing barberry juice in people with Type 2 Diabetes, run by National Nutrition and Food Technology Institute.
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 3 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 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
fasting blood glucose (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 2 Oct 2017.