Investigations on the Effect of Kale on the Lipid Status
HypocholKale
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2018
CompletedFirst Submitted
Initial submission to the registry
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 4, 2018
May 1, 2018
5 months
May 7, 2018
May 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of lipid status parameters
total cholesterol, HDL cholesterol, LDL cholesterol
weeks 0, 4 and 8
Secondary Outcomes (2)
Change of apolipoproteins
weeks 0, 4 and 8
Change of antioxidant capacity
weeks 0, 4 and 8
Study Arms (4)
Kale Powder
EXPERIMENTAL5 capsules with kale preparation "kale powder" per day for 8 weeks
Kale Extract
EXPERIMENTAL5 capsules with kale preparation "kale extract" per day for 8 weeks
Flavonoid Extract
EXPERIMENTAL5 capsules with kale preparation "flavonoid extract" (from kale) per day for 8 weeks
Placebo
PLACEBO COMPARATOR5 capsules with "placebo" per day for 8 weeks
Interventions
Effect of kale preparation kale powder on lipid status
Effect of kale preparation kale extract on lipid status
Effect of kale preparation flavonoid extract on lipid status
Eligibility Criteria
You may qualify if:
- total cholesterol \> 200 mg/dl
You may not qualify if:
- LDL cholesterol \< 130 mg/dl
- medication to lower blood lipids
- genetically based hypercholesterolemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Friedrich Schiller University, Institute iof Nutritional Science
Jena, Thuringia, 07743, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Bioactive Plant Products Research Group
Study Record Dates
First Submitted
May 7, 2018
First Posted
June 4, 2018
Study Start
April 13, 2018
Primary Completion
September 1, 2018
Study Completion
December 1, 2020
Last Updated
June 4, 2018
Record last verified: 2018-05