Type2 DiabetesNCT04298970
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
A study testing Intervention in people with Type2 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Mar 2020to 1 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes, dietary treatment and/or with oral anti-diabetics
- Diabetes debut > 30 year
- Plasma fasting blood glucose > 4mM and < 12 mM
- HbA1c > 43 and ≤ 108 mmol/mol
- BMI between 23-40 kg/m2
- Fasting triglyceride > 1.7 mmol/L and HDL-cholesterol, men: < 1.03 mmol/L and women: 1.29 mmol/L.
Who cannot join
- Participating or have been participating in other clinical trials within the last 2 months.
- In treatment with insulin, systemic glucocorticoids, glitazones or GLP-1 analogs.
- Cardiovascular-, physiological-, neurological-, and/or kidney diseases.
- Alcohol- or pill abuse.
- Acute diseases.
- Blood pressure ≥ 160/100
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes.
- Conditions
- Type2 Diabetes
- Being tested
- Intervention, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDietary supplement
Freeze-dried Brassica oleracea var. acephala
PlaceboDietary supplement
Placebo product
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Consuming a product containing 35-40 gram of freeze dried kale a day. Receives: Dietary Supplement: Intervention |
| Placebo | Placebo comparator | Consuming a placebo product. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
iAUC
The blood glucose incremental area under curve, OGTT
Measured: Throughout the study (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start3 Mar 2020
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Future Food Innovation
- Responsible party
- Principal investigator, Per Bendix Jeppesen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298970
- Sponsor's protocol ID
- AU/AUH
- Status last verified
- Dec 2023
- First submitted
- 3 Mar 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04298970
- Acronym / sponsor ID
- AU/AUH
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Future Food Innovation
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 6 Mar 2020 (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.
Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: InterventionConsuming a product containing 35-40 gram of freeze dried kale a day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboConsuming a placebo product. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes, dietary treatment and/or with oral anti-diabetics
- Diabetes debut > 30 year
- Plasma fasting blood glucose > 4mM and < 12 mM
- HbA1c > 43 and ≤ 108 mmol/mol
- BMI between 23-40 kg/m2
Key exclusion criteria (7 listed)
- Participating or have been participating in other clinical trials within the last 2 months.
- In treatment with insulin, systemic glucocorticoids, glitazones or GLP-1 analogs.
- Cardiovascular-, physiological-, neurological-, and/or kidney diseases.
- Alcohol- or pill abuse.
- Acute 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 |
|---|---|---|
| InterventionFreeze-dried Brassica oleracea var. acephala | Dietary supplement | Intervention |
| PlaceboPlacebo product | Dietary supplement | Placebo |
Primary outcome
iAUC
Time frame: Throughout the study (up to 1 year)
The blood glucose incremental area under curve, OGTT
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 4 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Type2 Diabetes, run by University of Aarhus 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 6 inclusion and 7 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 4 Dec 2023. 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. 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.
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?
iAUC (time frame: Throughout the study (up to 1 year)). 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 4 Dec 2023.