Investigations on the Effect of Kale on the Lipid Status

Not Applicable

• Conditions: Effects of Kale Ingredients on Lipid Status Parameter
• Interventions: Dietary Supplement: Kale Preparation "Kale Powder"; Dietary Supplement: Kale Preparation "Kale Extract"; Dietary Supplement: Kale Preparation "Flavonoid Extract"; Dietary Supplement: Placebo

• Registration Number: NCT03545555
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-13
• Status Verified: 2018-05
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-22
• Last Update Submitted: 2018-05-22
• Study First Posted: 2018-06-04
• Last Update Posted: 2018-06-04
• Primary Completion: 2018-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• total cholesterol > 200 mg/dl

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kale Powder	Kale Preparation "Kale Powder"	5 capsules with kale preparation "kale powder" per day for 8 weeks
Kale Extract	Kale Preparation "Kale Extract"	5 capsules with kale preparation "kale extract" per day for 8 weeks
Flavonoid Extract	Kale Preparation "Flavonoid Extract"	5 capsules with kale preparation "flavonoid extract" (from kale) per day for 8 weeks
Placebo	Placebo	5 capsules with "placebo" per day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change of lipid status parameters	weeks 0, 4 and 8	total cholesterol, HDL cholesterol, LDL cholesterol

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Friedrich Schiller University, Institute iof Nutritional Science; 🇩🇪 Jena, Thuringia, Germany