We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified June 2016 by Volker Boehm, University of Jena
Sponsor:
ClinicalTrials.gov Identifier:
NCT02136303
First Posted: May 13, 2014
Last Update Posted: June 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Volker Boehm, University of Jena
  Purpose

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 Intervention
Changes in Macular Pigment Optical Density Dietary Supplement: S1: Dosage-dependency Other: S2: Kale extract versus kale purée Other: S3: Kale extract: AMD-patients

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Volker Boehm, University of Jena:

Primary Outcome Measures:
  • changes in macular pigment optical density MPOD [ODU: optical density units] [ Time Frame: 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]


Estimated Enrollment: 90
Study Start Date: February 2015
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy, > 18 years, written consent

Exclusion Criteria:

  • uptake of dietary supplements, glaucoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136303


Contacts
Contact: Volker Böhm, Dr. +49-(0)3641-949633 Volker.Boehm@uni-jena.de

Locations
Germany
University Eye Hospital, Friedrich Schiller University Jena Recruiting
Jena, Germany, 07743
Sponsors and Collaborators
University of Jena