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Trial record 62 of 93 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

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

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ClinicalTrials.gov Identifier: NCT03545555
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Volker Boehm, University of Jena

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.

Condition or disease Intervention/treatment Phase
Effects of Kale Ingredients on Lipid Status Parameter Dietary Supplement: Kale Preparation "Kale Powder" Dietary Supplement: Kale Preparation "Kale Extract" Dietary Supplement: Kale Preparation "Flavonoid Extract" Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Investigations on the Effect of Kale on the Lipid Status (Untersuchungen Zum Einfluss Von Grünkohl Auf Den Lipidstatus)
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2020

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




Primary Outcome Measures :
  1. Change of lipid status parameters [ Time Frame: weeks 0, 4 and 8 ]
    total cholesterol, HDL cholesterol, LDL cholesterol


Secondary Outcome Measures :
  1. Change of apolipoproteins [ Time Frame: weeks 0, 4 and 8 ]
    apolipoprotein A1 and apolipoprotein B

  2. Change of antioxidant capacity [ Time Frame: weeks 0, 4 and 8 ]
    lipophilic antioxidant capacity (L-TEAC)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • total cholesterol > 200 mg/dl

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545555


Contacts
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Contact: Volker Böhm, PD Dr. +49-(0)3641-9496 ext 33 Volker.Boehm@uni-jena.de

Locations
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Germany
Friedrich Schiller University, Institute iof Nutritional Science Recruiting
Jena, Thuringia, Germany, 07743
Contact: Volker Boehm, PD Dr.    +(49)3641/949633    volker.boehm@uni-jena.de   
Sponsors and Collaborators
University of Jena

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Responsible Party: Volker Boehm, Head of Bioactive Plant Products Research Group, University of Jena
ClinicalTrials.gov Identifier: NCT03545555     History of Changes
Other Study ID Numbers: AGBAP2018-1
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Volker Boehm, University of Jena:
kale
antioxidant capacity
cholesterol
lipid status