Investigations on the Effect of Kale on the Lipid Status

Effects of Kale Ingredients on Lipid Status Parameter Clinical Trial

— HypocholKale  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545555
• Other study ID #: AGBAP2018-1
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: December 2020

Study information

• Verified date: May 2018
• Source: University of Jena
• Contact: Volker Böhm, PD Dr.
• Phone: +49-(0)3641-9496
• Email: Volker.Boehm[@]uni-jena.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• total cholesterol > 200 mg/dl

Exclusion Criteria:

• LDL cholesterol < 130 mg/dl

• medication to lower blood lipids

• genetically based hypercholesterolemia

Related Conditions & MeSH terms

• Effects of Kale Ingredients on Lipid Status Parameter

Intervention

Dietary Supplement:
• Kale Preparation "Kale Powder"
Effect of kale preparation kale powder on lipid status
• Kale Preparation "Kale Extract"
Effect of kale preparation kale extract on lipid status
• Kale Preparation "Flavonoid Extract"
Effect of kale preparation flavonoid extract on lipid status
• Placebo
Effect of placebo on lipid status

Locations

Country	Name	City	State
Germany	Friedrich Schiller University, Institute iof Nutritional Science	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of lipid status parameters	total cholesterol, HDL cholesterol, LDL cholesterol	weeks 0, 4 and 8
Secondary	Change of apolipoproteins	apolipoprotein A1 and apolipoprotein B	weeks 0, 4 and 8
Secondary	Change of antioxidant capacity	lipophilic antioxidant capacity (L-TEAC)	weeks 0, 4 and 8