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

University of Jena

Status: Unknown

Conditions: Effects of Kale Ingredients on Lipid Status Parameter

Treatments: Dietary Supplement: Kale Preparation "Kale Extract"; Dietary Supplement: Kale Preparation "Kale Powder"; Dietary Supplement: Kale Preparation "Flavonoid Extract"; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03545555

AGBAP2018-1

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• total cholesterol > 200 mg/dl

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

Kale Powder

Experimental group

Description:

5 capsules with kale preparation "kale powder" per day for 8 weeks

Treatment:

Dietary Supplement: Kale Preparation "Kale Powder"

Kale Extract

Experimental group

Description:

5 capsules with kale preparation "kale extract" per day for 8 weeks

Treatment:

Dietary Supplement: Kale Preparation "Kale Extract"

Flavonoid Extract

Experimental group

Description:

5 capsules with kale preparation "flavonoid extract" (from kale) per day for 8 weeks

Treatment:

Dietary Supplement: Kale Preparation "Flavonoid Extract"

Placebo

Placebo Comparator group

Description:

5 capsules with "placebo" per day for 8 weeks

Treatment:

Dietary Supplement: Placebo