Investigations on the Effect of Kale on the Lipid Status

Study Overview
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Brief Summary
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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.

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

Conditions
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Effects of Kale Ingredients on Lipid Status Parameter

Intervention / Treatment
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* Dietary Supplement: Kale Preparation Kale Powder
* Dietary Supplement: Kale Preparation Kale Extract
* Dietary Supplement: Kale Preparation Flavonoid Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: total cholesterol > 200 mg/dl Exclusion Criteria: LDL cholesterol < 130 mg/dl medication to lower blood lipids genetically based hypercholesterolemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antioxidant capacity, cholesterol, lipid status, kale