Investigations on the Effect of Kale on the Lipid Status | NCT03545555

Studies
Investigations on the Effect of Kale on the Lipid Status

NCT03545555

Sponsor

University of Jena

Status

Unknown status

Last Update Posted

Jun 4, 2018Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Effects of Kale Ingredients on Lipid Status Parameter

Interventions

Kale Preparation "Kale Powder"
Kale Preparation "Kale Extract"
Kale Preparation "Flavonoid Extract"
Placebo

Countries

Germany

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

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2018Actual

Primary Completion Date

Sep 2018Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

May 7, 2018

First Submission Date that Met QC Criteria

May 22, 2018

First Posted Date

Jun 4, 2018Actual

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

May 22, 2018

Last Update Posted Date

Jun 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Volker Boehm, Head of Bioactive Plant Products Research Group, University of JenaPrincipal Investigator

Lead Sponsor

University of JenaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This intervention study investigates the effects of various kale preparations (dietary supplements) on lipid status parameters. Within the study period of 8 weeks, three blood withdrawals are planned (week 0, 4 and 8) for the volunteers. Lipid status parameters (total cholesterol, HDL cholesterol, LDL cholesterol, triacylglycerides) will be determined in blood. There is a correlation between contents of LDL cholesterol, total cholesterol and triacylglycerides and the risk for cardiovascular diseases (CVD). In contrast, a high content of HDL cholesterol is correlated with a lower risk for CVD. In addition, the contents of apolipoprotein A1 and apolipoprotein B will be analysed.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kale Powder	Experimental	5 capsules with kale preparation "kale powder" per day for 8 weeks	Dietary Supplement: Kale Preparation "Kale Powder"
Kale Extract	Experimental	5 capsules with kale preparation "kale extract" per day for 8 weeks	Dietary Supplement: Kale Preparation "Kale Extract"
Flavonoid Extract	Experimental	5 capsules with kale preparation "flavonoid extract" (from kale) per day for 8 weeks	Dietary Supplement: Kale Preparation "Flavonoid Extract"
Placebo	Placebo Comparator	5 capsules with "placebo" per day for 8 weeks	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kale Preparation "Kale Powder"	Dietary Supplement	Effect of kale preparation kale powder on lipid status	Kale Powder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of lipid status parameters	total cholesterol, HDL cholesterol, LDL cholesterol	weeks 0, 4 and 8

Secondary Outcomes

Measure	Description	Time Frame
Change of apolipoproteins	apolipoprotein A1 and apolipoprotein B	weeks 0, 4 and 8
Change of antioxidant capacity	lipophilic antioxidant capacity (L-TEAC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

total cholesterol > 200 mg/dl

Exclusion Criteria:

LDL cholesterol < 130 mg/dl
medication to lower blood lipids
genetically based hypercholesterolemia

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Volker Böhm, PD Dr.	Contact	+49-(0)3641-9496	33	Volker.Boehm@uni-jena.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Friedrich Schiller University, Institute iof Nutritional Science	Recruiting	Jena	Thuringia	07743	Germany