Investigations on the Effect of Kale on the Lipid Status (HypocholKale)

May 22, 2018 updated by: Volker Boehm, University of Jena

Investigations on the Effect of Kale on the Lipid Status (Untersuchungen Zum Einfluss Von Grünkohl Auf Den Lipidstatus)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07743
        • Recruiting
        • Friedrich Schiller University, Institute iof Nutritional Science
        • Contact:

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • total cholesterol > 200 mg/dl

Exclusion Criteria:

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kale Powder
5 capsules with kale preparation "kale powder" per day for 8 weeks
Dietary supplement: Kale Preparation "Kale Powder"
Effect of kale preparation kale powder on lipid status
Experimental: Kale Extract
5 capsules with kale preparation "kale extract" per day for 8 weeks
Dietary supplement: Kale Preparation "Kale Extract"
Effect of kale preparation kale extract on lipid status
Experimental: Flavonoid Extract
5 capsules with kale preparation "flavonoid extract" (from kale) per day for 8 weeks
Dietary supplement: Kale Preparation "Flavonoid Extract"
Effect of kale preparation flavonoid extract on lipid status
Placebo Comparator: Placebo
5 capsules with "placebo" per day for 8 weeks
Dietary supplement: Placebo
Effect of placebo on lipid status

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

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)

April 13, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AGBAP2018-1

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.

Clinical Trials on Effects of Kale Ingredients on Lipid Status Parameter

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