- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298970
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
December 1, 2023 updated by: Per Bendix Jeppesen, University of Aarhus
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aarhus C, Denmark, 8000
- Aarhus University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention
Consuming a product containing 35-40 gram of freeze dried kale a day.
|
Freeze-dried Brassica oleracea var.
acephala
|
Placebo Comparator: Placebo
Consuming a placebo product.
|
Placebo product
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iAUC
Time Frame: Throughout the study (up to 1 year)
|
The blood glucose incremental area under curve, OGTT
|
Throughout the study (up to 1 year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2020
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (Actual)
March 6, 2020
Study Record Updates
Last Update Posted (Actual)
December 4, 2023
Last Update Submitted That Met QC Criteria
December 1, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU/AUH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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