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Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes

Primary Purpose

Type2 Diabetes

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intervention
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Consuming a product containing 35-40 gram of freeze dried kale a day.

Consuming a placebo product.

Outcomes

Primary Outcome Measures

iAUC
The blood glucose incremental area under curve, OGTT

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
May 17, 2022
Sponsor
University of Aarhus
Collaborators
Future Food Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT04298970
Brief Title
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
Official Title
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Future Food Innovation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Consuming a product containing 35-40 gram of freeze dried kale a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Consuming a placebo product.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention
Intervention Description
Freeze-dried Brassica oleracea var. acephala
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo product
Primary Outcome Measure Information:
Title
iAUC
Description
The blood glucose incremental area under curve, OGTT
Time Frame
Throughout the study (up to 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Aarhus University
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes

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