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

NCT ID: NCT02136303

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2020-12-31

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.

Conditions

Changes in Macular Pigment Optical Density

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

S1-Placebo

placebo capsule with all ingredients, but without active compound, intervention for 4 weeks, S1: Dosage-dependency

Group Type: PLACEBO_COMPARATOR

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

S1-1L

capsule containing 1 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency

Group Type: EXPERIMENTAL

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

S1-2L

capsule containing 2 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency

Group Type: EXPERIMENTAL

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

S1-5L

capsule containing 5 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency

Group Type: EXPERIMENTAL

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

S2-Kale_extract

Group Type: EXPERIMENTAL

S2: Kale extract versus kale purée

Intervention Type: OTHER

S2-Kale_purée

Group Type: EXPERIMENTAL

S2: Kale extract versus kale purée

Intervention Type: OTHER

S3-Placebo

Group Type: PLACEBO_COMPARATOR

S3: Kale extract: AMD-patients

Intervention Type: OTHER

S3-AMD-Patients

Group Type: EXPERIMENTAL

S3: Kale extract: AMD-patients

Intervention Type: OTHER

S3-non-AMD

Group Type: EXPERIMENTAL

S3: Kale extract: AMD-patients

Intervention Type: OTHER

S1-Placebo-Tagetes

capsule containing all ingredients, but without active compound, intervention for 4 weeks, S1: Dosage-dependency

Group Type: PLACEBO_COMPARATOR

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

S1-1L-Tagetes

capsule containing 1 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency

Group Type: EXPERIMENTAL

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

S1-2L-Tagetes

capsule containing 2 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency

Group Type: EXPERIMENTAL

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

S1-5L-Tagetes

capsule containing 5 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency

Group Type: EXPERIMENTAL

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

S1-10L-Tagetes

capsule containing 10 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency

Group Type: EXPERIMENTAL

S1: Dosage-dependency

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

S2: Kale extract versus kale purée

Intervention Type: OTHER

S3: Kale extract: AMD-patients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• healthy, > 18 years, written consent

Exclusion Criteria

• uptake of dietary supplements, glaucoma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

Volker Boehm

PD Dr. Volker Böhm

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Eye Hospital, Friedrich Schiller University Jena

Jena, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Volker Böhm, Dr.

Role: CONTACT

Volker.Boehm@uni-jena.de

+49-(0)3641-949633

References

Arnold C, Winter L, Frohlich K, Jentsch S, Dawczynski J, Jahreis G, Bohm V. Macular xanthophylls and omega-3 long-chain polyunsaturated fatty acids in age-related macular degeneration: a randomized trial. JAMA Ophthalmol. 2013 May;131(5):564-72. doi: 10.1001/jamaophthalmol.2013.2851.

Reference Type: RESULT

PMID: 23519529 (View on PubMed)

Arnold C, Jentsch S, Dawczynski J, Bohm V. Age-related macular degeneration: Effects of a short-term intervention with an oleaginous kale extract--a pilot study. Nutrition. 2013 Nov-Dec;29(11-12):1412-7. doi: 10.1016/j.nut.2013.05.012.

Reference Type: RESULT

PMID: 24103519 (View on PubMed)

Other Identifiers

BO 1511/8-1

Identifier Type: -

Identifier Source: org_study_id