Type 2 DiabetesMAXVEGNCT01397942
Maximising the Taste and Health Value of Plant Food Products
A study testing Diet intervention in people with Type 2 Diabetes, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
To investigate if a high dietary intake of bitter and strong tasting vegetables have positive health effects (insulin sensitivity, glucose tolerance, central obesity, fasting and postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers, biomarkers of oxidative stress) on subjects with T2D. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Jan 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes in diet treatment or on oral anti-diabetic drug or the metabolic syndrome.
Who cannot join
- Other severe diseases or in treatment with insulin, GLP-1 analogs, glitazones.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hospital Vendsyssel, Center for Clinical Research
Hjørring, North Denmark, 9800
About this study
Official title: Maximising the Taste and Health Value of Plant Food Products - Impact on Vegetable Consumption, Consumer Preferences and Human Health Factors.
To investigate if a high dietary intake of bitter and strong tasting vegetables have positive health effects (insulin sensitivity, glucose tolerance, central obesity, fasting and postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers, biomarkers of oxidative stress) on subjects with T2D. Also to look at a high dietary intake of mild and sweet modern vegetables or a normal western diet.
Read the detailed description
The metabolic syndrome (MS), type 2 diabetes (T2D) and obesity are the world's most prevalent lifestyle diseases. This unfortunate development is mainly caused by lifestyle choices leading to obesity due to physical inactivity and excessive calorie intake.
Vegetables are an important part of the human diet and a major source of biologically active substances which determine the nutritional quality of food, color, taste, smell, antioxidative, anticarcinogenic, antihypertensive, anti-inflammatory, antihyperglycemia, immunostimulating and cholesterol-lowering properties.
Diet, as one aspect of lifestyle, is thought to be one of the modifiable variable risk factors for the development of MS and T2D, but more information is needed as to which components of the diet could be protective for the development and progression of MS and T2D with all its complications.
The study will be carried out as a 3-month randomized controlled parallel intervention study involving 60 subjects with T2D. During the fall year 2011 30 (10 in each group) subjects will participate and the remaining 30 subjects (10 in each group) in the fall 2012. The subjects will be randomized into 3 different diets:
- A) "A healthy Nordic diet" with high content of bitter strong tasting vegetables and cabbages.
- B) "A healthy Nordic diet" with high content of sweet and mild tasting vegetables and cabbages.
- C) A diet habitually consumed in the Nordic countries (normal control diet). The subjects in groups A and B will each have to consume 500 g root vegetables and cabbages daily which will be handed out once a week. The participants will visit the study clinic at screening, and then once weekly during the intervention period (12 weeks). Beside the screening examination there will be 3 major visits (0, 6 and 12 weeks) where the participants will collect urine samples, complete a 3-day weighed food diary (to control diet intake) and undergo clinical examination incl. measuring of blood pressure, body composition and collection of fasting blood samples i.e. glucose, insulin, glucagon, HbA1c, GLP-1, lipids (triglycerides, HDL-, LDL- and total cholesterol), cytokines, adipokines, parathyroid hormone and vitamin D. During first (week 0) and third (week 12) major visit a 120 minutes oral glucose tolerance test is included collecting blood to analyze for glucose, insulin and triglycerides.
The study will contribute to the understanding on the impact of a diet with a high level of root vegetables and cabbages with either high or low levels of phytochemicals. Furthermore, the results can be used to develop new recommendations targeted T2D and MS subjects, and thereby contribute to a healthier lifestyle and to prevent any further development and progression of these lifestyle diseases. The overall perspective of the MAXVEG project is to enhance the consumption and production of bitter and strong tasting health promoting root vegetables and cabbages with high phytochemical content and high consumer preferences targeted specific consumer groups
- Conditions
- Type 2 Diabetes
- Being tested
- Diet intervention
- Keywords
- Diet intervention, Type 2 diabetes, Vegetables, Phytochemicals
- 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.
Diet interventionOther
Also called Vegetables, Ancient, Cabbages, Type 2 diabetes
The participants in the two experimental arms will each have to consume 500 g of vegetables and cabbages daily.
| Study group | Role | What they receive |
|---|---|---|
| Diet intervention - Ancient vegatables | Experimental | A healthy Nordic diet with high content of bitter strong tasting vegetables and cabbages. Receives: Other: Diet intervention |
| Control Nordic diet | No intervention | A diet habitually consumed in the Nordic countries |
| Diet intervention - Modern Vegetables | Experimental | A healthy Nordic diet with high content of sweet and mild tasting vegetables and cabbages. Receives: Other: Diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured as the AUC from an Oral Glucose Tolerance Test
Measured: 2 years
Secondary outcomes (1)
Urine and blood samples
The fasting blood samples will be analyzed for: glucose, insulin, glucagon, HbA1c, lipids (triglycerides, HDL-, LDL- and total cholesterol), cytokines (, adipokines biomarkers of oxidative stress parathyroid hormone, vitamin D and GLP-1.
Urine samples for metabolomics (isoprostanes and water-soluble metabolites).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionJan 2015
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 Aarhus University 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Bendix Jeppesen, Aarhus University Hospital
- Investigators
- Per B Jeppesen, Prof. PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397942
- Sponsor's protocol ID
- 09-067129
- Acronym
- MAXVEG
- Status last verified
- Mar 2015
- First submitted
- 18 Jul 2011
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximising the Taste and Health Value of Plant Food Products - Impact on Vegetable Consumption, Consumer Preferences and Human Health Factors.
- ClinicalTrials.gov ID
- NCT01397942
- Acronym / sponsor ID
- MAXVEG / 09-067129
- Conditions
- Type 2 Diabetes
- Keywords
- Diet intervention, Type 2 diabetes, Vegetables, Phytochemicals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Jul 2011 (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.
To investigate if a high dietary intake of bitter and strong tasting vegetables have positive health effects (insulin sensitivity, glucose tolerance, central obesity, fasting and postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers, biomarkers of oxidative stress) on subjects with T2D. Also to look at a high dietary intake of mild and sweet modern vegetables or a normal western diet.
Detailed description
The metabolic syndrome (MS), type 2 diabetes (T2D) and obesity are the world's most prevalent lifestyle diseases. This unfortunate development is mainly caused by lifestyle choices leading to obesity due to physical inactivity and excessive calorie intake.
Vegetables are an important part of the human diet and a major source of biologically active substances which determine the nutritional quality of food, color, taste, smell, antioxidative, anticarcinogenic, antihypertensive, anti-inflammatory, antihyperglycemia, immunostimulating and cholesterol-lowering properties.
Diet, as one aspect of lifestyle, is thought to be one of the modifiable variable risk factors for the development of MS and T2D, but more information is needed as to which components of the diet could be protective for the development and progression of MS and T2D with all its complications.
The study will be carried out as a 3-month randomized controlled parallel intervention study involving 60 subjects with T2D. During the fall year 2011 30 (10 in each group) subjects will participate and the remaining 30 subjects (10 in each group) in the fall 2012. The subjects will be randomized into 3 different diets:
- A) "A healthy Nordic diet" with high content of bitter strong tasting vegetables and cabbages.
- B) "A healthy Nordic diet" with high content of sweet and mild tasting vegetables and cabbages.
- C) A diet habitually consumed in the Nordic countries (normal control diet). The subjects in groups A and B will each have to consume 500 g root vegetables and cabbages daily which will be handed out once a week. The participants will visit the study clinic at screening, and then once weekly during the intervention period (12 weeks). Beside the screening examination there will be 3 major visits (0, 6 and 12 weeks) where the participants will collect urine samples, complete a 3-day weighed food diary (to control diet intake) and undergo clinical examination incl. measuring of blood pressure, body composition and collection of fasting blood samples i.e. glucose, insulin, glucagon, HbA1c, GLP-1, lipids (triglycerides, HDL-, LDL- and total cholesterol), cytokines, adipokines, parathyroid hormone and vitamin D. During first (week 0) and third (week 12) major visit a 120 minutes oral glucose tolerance test is included collecting blood to analyze for glucose, insulin and triglycerides.
The study will contribute to the understanding on the impact of a diet with a high level of root vegetables and cabbages with either high or low levels of phytochemicals. Furthermore, the results can be used to develop new recommendations targeted T2D and MS subjects, and thereby contribute to a healthier lifestyle and to prevent any further development and progression of these lifestyle diseases. The overall perspective of the MAXVEG project is to enhance the consumption and production of bitter and strong tasting health promoting root vegetables and cabbages with high phytochemical content and high consumer preferences targeted specific consumer groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet intervention - Ancient vegatables | Experimental | Other: Diet interventionA healthy Nordic diet with high content of bitter strong tasting vegetables and cabbages. |
| Control Nordic diet | No intervention | –A diet habitually consumed in the Nordic countries |
| Diet intervention - Modern Vegetables | Experimental | Other: Diet interventionA healthy Nordic diet with high content of sweet and mild tasting vegetables and cabbages. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes in diet treatment or on oral anti-diabetic drug or the metabolic syndrome.
Key exclusion criteria (1 listed)
- Other severe diseases or in treatment with insulin, GLP-1 analogs, glitazones.
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 |
|---|---|---|
| Diet interventionAlso: Vegetables, Ancient, Cabbages, Type 2 diabetesThe participants in the two experimental arms will each have to consume 500 g of vegetables and cabbages daily. | Other | Diet intervention - Ancient vegatables, Diet intervention - Modern Vegetables |
Primary outcome
Insulin sensitivity
Time frame: 2 years
Measured as the AUC from an Oral Glucose Tolerance Test
1 secondary outcome
Urine and blood samples
Time frame: 2 years
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 11 Mar 2015.
- Click here for more information about this study: Maximising the Taste and Health Value of Plant Food Products (MAXVEG)Link provided by the sponsor.
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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.
Per B Jeppesen, Prof. PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention in people with Type 2 Diabetes, run by Aarhus University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 11 Mar 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 Denmark. 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.
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?
Insulin sensitivity (time frame: 2 years). 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 11 Mar 2015.