KALESIGHT: Regional Kale as Source of Lutein and Zeaxanthin to Improve Vision of AMD-patients

Sponsor

University of Jena (Other)

Overall Status

Unknown status

CT.gov ID

NCT02136303

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The age-related macular degeneration (AMD) is an age-dependent, multi-factorial disease. In Western industrial countries, it is the main cause of visual impairments. In Germany, approximately 4.5 million people suffer from AMD. Genetic as well as nutritional aspects are mainly important in AMD development. Until now, AMD-patients are advised to use supplements based on the carotenoids lutein and zeaxanthin, comprised in high doses and in isolated form. Results showing the effects of food items (kale, spinach) rich in lutein on improvement of vision are scarce. And how much is needed within the diet? Within the planned project, human intervention studies will investigate whether an oil-based kale extract or fresh kale can be used to improve vision of AMD-patients and persons aged 50+ (without AMD). The first study will use volunteers without AMD (>18 y) to investigate if there is a dose-dependent effect of lutein and zeaxanthin (out of a kale extract) on macular pigment optical density (MPOD). This study will also compare the bioavailability of the carotenoids from the extract and from a supplement. A second study (also using volunteers without AMD, >18 y) will compare the bioavailability of lutein and zeaxanthin from the extract and from kale purée. The third study will investigate the effect of the oil-based kale extract on improvements of MPOD and vision of AMD-patients and of a control group (volunteers 50+ without AMD).

Usually, the intestinal absorption of lutein and zeaxanthin is determined by analyzing changes in concentrations in blood plasma. A fast, non-invasive sampling will be evaluated to check the efficacy of an increased uptake of lutein. Thus, the project will test the usability of buccal mucosa cells to detect metabolic changes after an uptake of carotenoids. Besides, the determination of carotenoid contents in skin will be checked on its use as biomarker of carotenoids in plasma and macula.

Thus, the planned research project will evaluate two non-invasive markers of exposition on their usability as markers of absorption of lutein and zeaxanthin in blood and macula. In addition, the minimally needed dosage of lutein and zeaxanthin for AMD prevention will be determined to reduce the possible risk of currently recommended doses of these compounds. The project will also present alternatives (kale extract, kale purée) for AMD prevention and to improve vision to be used instead of currently used high-dose supplements.

Condition or Disease	Intervention/Treatment	Phase
Changes in Macular Pigment Optical Density	Dietary Supplement: S1: Dosage-dependency Other: S2: Kale extract versus kale purée Other: S3: Kale extract: AMD-patients	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Regional Kale as Source of Lutein and Zeaxanthin to Improve Vision of Patients With Age-related Macular Degeneration - an Alternative to Supplements With Isolated Xanthophylls

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: S1-Placebo placebo capsule with all ingredients, but without active compound, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
Experimental: S1-1L capsule containing 1 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
Experimental: S1-2L capsule containing 2 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
Experimental: S1-5L capsule containing 5 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
Experimental: S2-Kale_extract	Other: S2: Kale extract versus kale purée
Experimental: S2-Kale_purée	Other: S2: Kale extract versus kale purée
Placebo Comparator: S3-Placebo	Other: S3: Kale extract: AMD-patients
Experimental: S3-AMD-Patients	Other: S3: Kale extract: AMD-patients
Experimental: S3-non-AMD	Other: S3: Kale extract: AMD-patients
Placebo Comparator: S1-Placebo-Tagetes capsule containing all ingredients, but without active compound, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
Experimental: S1-1L-Tagetes capsule containing 1 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
Experimental: S1-2L-Tagetes capsule containing 2 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
Experimental: S1-5L-Tagetes capsule containing 5 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
Experimental: S1-10L-Tagetes capsule containing 10 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency	Dietary Supplement: S1: Dosage-dependency kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein

Outcome Measures

Primary Outcome Measures

changes in macular pigment optical density MPOD [ODU: optical density units] [baseline and after 4/8 weeks, baseline and after 6/12/18/24 weeks]
Changes from baseline to various time points for different parameters of MPOD will be measured: changes in mean MPOD [ODU], changes in max. MPOD [ODU], changes in volume of MPOD [ODU x (degree)2], changes in area of MPOD [degree2]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy, > 18 years, written consent

Exclusion Criteria:

uptake of dietary supplements, glaucoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Eye Hospital, Friedrich Schiller University Jena	Jena		Germany	07743

Sponsors and Collaborators

University of Jena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Volker Boehm, PD Dr. Volker Böhm, University of Jena

ClinicalTrials.gov Identifier:

NCT02136303

Other Study ID Numbers:

BO 1511/8-1

First Posted:

May 13, 2014

Last Update Posted:

May 8, 2018

Last Verified:

May 1, 2018

Study Results

No Results Posted as of May 8, 2018