Novel Organic Kale Products for Prevention of Obesity/Typ... | NCT04298970

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

NCT04298970

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Dec 4, 2023Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Type2 Diabetes

Interventions

Intervention
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2020Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

Mar 3, 2020

First Submission Date that Met QC Criteria

Mar 5, 2020

First Posted Date

Mar 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2023

Last Update Posted Date

Dec 4, 2023Actual

Name	Class
Future Food Innovation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	Consuming a product containing 35-40 gram of freeze dried kale a day.	Dietary Supplement: Intervention
Placebo	Placebo Comparator	Consuming a placebo product.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intervention	Dietary Supplement	Freeze-dried Brassica oleracea var. acephala	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
iAUC	The blood glucose incremental area under curve, OGTT	Throughout the study (up to 1 year)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University		Aarhus C		8000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided