The Potential Role of Dietary Antioxidant Capacity on Age-Related Macular Degeneration

NCT03326401 | Completed

• 1 other identifier: GO 15/628
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Including eye health, nutrition plays a vital role for the sustainability of individuals health life. There is an increasing global concern about the issues related with eye health. In 2010, in order to take attention to these issues, World Health Organization (WHO) defined the main reasons of vision disorders as refraction defects of eye diseases (43 %), cataract (33 %), glaucoma (2 %), age-related macular degeneration (AMD) (1 %), diabetic retinopathy (1 %) and undetermined natural reasons (18 %). This report also stated the three biggest reasons of blindness as cataract (51 %), glaucoma (8 %) and AMD (5 %). AMD is a multi-factorial disease in which the genetic predisposition plays important role with environmental factors and metabolic conditions, except for age. Especially cigarette is the secondary important risk factor for dry-type AMD. In the Age Related Eye Disease Study (AREDS), it was stated that AMD prevalence is higher in white races, compared with races which are not white. At the same time, AREDS searched the effect of diet supplements on the progression of AMD disease. In terms of the patients followed for six years, it was reported that the formulation C and E vitamins, beta carotene and zinc decreased the progression risk of AMD from middle levels to advanced levels by 34 %. In AREDS-2 study completed in 2012, it was shown that the extraction of beta carotene from the formulation and the decrease of zinc did not affect the progression rate of the disease. In the group using beta carotene, including persons who were used to smoke but gave up at least one year ago, the rate of becoming lung cancer was observed as substantially high. Moreover, the use of lutein and zeaxanthin instead of beta carotene in the formula did not increase the risk of lung cancer. In addition, it was shown that omega-3 fatty acids did not decrease risk progression. In current data, the effect of the intake of carotenoid and antioxidant increased with diet on AMD is not coherent. Likewise, the epidemiological evidences about the relation between diet fat intake and AMD are contradictory. The consumption of fatty fish is related with increased poly-unsaturated fatty acid intake and decreases the risk of AMD. However, it was reported the high rate of total fat intake in other studies as risk factor for AMD. In another study, there was not any important relation found between diet fat intake and AMD occurrence after the correction of other variables. In the interventional AREDS-2 study, it was reported that the additional intake of long-chain omega-3 poly-unsaturated fatty acids did not have any beneficial effect. The pathophysiological mechanism responsible from the possible relation between obesity and AMD is not clearly known. There are various hypotheses about how obesity causes AMD. In the first hypothesis, obesity can cause AMD after obesity increases systematic oxidative stress. In the second hypothesis, obesity can play a role in AMD pathophysiology as the cause of hyperleptinemia. The studies also prescribed that inflammation could play a role in the progression of AMD and also showed that plasma fibrinogen and other inflammation indicators could be related with late AMD. In Pathologies Oculaires Liées à l'Age (POLA) study made with the participation of many Europeans, it was observed that the progression of late AMD increased by two times in obese individuals and in early AMD, obesity did not affect the progression of disease. In the treatment of this disease which have age-related progression, proper nutrition, vitamin/mineral/supplement usage and the development of precautionary strategies play an important role. When compared with Body Mass Index (BMI), it was found that the measure of abdominal obesity (waist/hip rate and waist circumference) was the better determinant of chronic diseases such as diabetics and cardiovascular disease. Some evidences in the United States of America indicated that the relation between waist/hip rate and AMD gave stronger results when compared with the relation between BMI and AMD. For middle age cohort, after six years of follow-up, a group of researchers reported that the decrease of waist/hip rate also decreased the risk of AMD and the results were the same for waist circumference, even if the evidences were weak. In another study, it was reported that the increase of waist/hip rate or waist circumference also increased the progression of AMD. This study was planned with the aim of determining the occurrence of AMD by evaluating dietary total antioxidant capacity, diet components and some anthropometric measures of individuals having age related macular degeneration (AMD). In the study, the possible effect of nutrition on the occurrence of disease was evaluated by comparing healthy individuals with dietary total antioxidant capacity and some anthropometric measures of individuals with AMD.

Conditions

Age Related Macular Degeneration

Keywords

dietary total antioxidant activity; nutritional status; macular degeneration; glycemic load; glycemic index; nutrient intake

Outcome Measures

Primary Outcomes (2)

• Body Mass Index (BMI)

  It will calculate by researcher with BMI formula: kg/m\^2

  up to 20 weeks

• Dietary total antioxidant capacity of participants

  3 day food record of participants will be taken and evaluated by researcher. Nutrition information System (BeBİS) software will be used for calculate daily consumption of nutrients.

  up to 20 weeks

Study Arms (2)

Case (AMD group)

Case group including 100 patients diagnosed with age-related macular degeneration (50 women, 50 men).Demographic data and dietary intake of different food groups were assessed by a standardized interviewer-assisted questionaire with the method of face-to-face interview. The body weight of the individuals were measured with a calibrated electronic scale,anthropometric measurements were measured by the researcher. Participants' dietary intake was assessed using food frequency questionaire (FFQ). The FFQ included 65 food items traditionally consumed in Turkey. Foods were classified into the following food categories: milk and dairy products, meat and meat products, fruits, vegetables, breads and cereals, beverages, and desserts.

Control (Non-AMD group)

Case group including 100 patients not diagnosed with age-related macular degeneration (50 women, 50 men).Demographic data and dietary intake of different food groups were assessed by a standardized interviewer-assisted questionaire with the method of face-to-face interview. The questionaire form, prepared to determine socio-demographic features of individuals participating in the research, was applied by the research with the method of face-to-face interview. The body weight of the individuals were measured with a calibrated electronic scale,anthropometric measurements were measured by the researcher. Participants' dietary intake was assessed using food frequency questionaire (FFQ). The FFQ included 65 food items traditionally consumed in Turkey. Foods were classified into the following food categories: milk and dairy products, meat and meat products, fruits, vegetables, breads and cereals, beverages, and desserts.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

200 individuals voluntarily participated into the study including 100 patients diagnosed with AMD (50 women, 50 men) and 100 patients not diagnosed as AMD (50 women, 50 men) as control group.

You may qualify if:

• Subject older than 50 years old
• Clinical diagnosis of Age-Related Macular Degeneration Disease (Both Dry and Wet type)

You may not qualify if:

• Subject complying with a special diet
• History of cardiovascular disease
• History of eye surgery
• Subject younger than 50 years old

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Hospital Department of Ophthalmology Polyclinic

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Related Publications (7)

• Schaumberg DA, Christen WG, Hankinson SE, Glynn RJ. Body mass index and the incidence of visually significant age-related maculopathy in men. Arch Ophthalmol. 2001 Sep;119(9):1259-65. doi: 10.1001/archopht.119.9.1259.

  PMID: 11545630 RESULT

• Klein BE, Klein R, Lee KE, Jensen SC. Measures of obesity and age-related eye diseases. Ophthalmic Epidemiol. 2001 Sep;8(4):251-62. doi: 10.1076/opep.8.4.251.1612.

  PMID: 11471093 RESULT

• Clemons TE, Milton RC, Klein R, Seddon JM, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Risk factors for the incidence of Advanced Age-Related Macular Degeneration in the Age-Related Eye Disease Study (AREDS) AREDS report no. 19. Ophthalmology. 2005 Apr;112(4):533-9. doi: 10.1016/j.ophtha.2004.10.047.

  PMID: 15808240 RESULT

• Defay R, Delcourt C, Ranvier M, Lacroux A, Papoz L. Relationships between physical activity, obesity and diabetes mellitus in a French elderly population: the POLA study. Pathologies Oculaires liees a l' Age. Int J Obes Relat Metab Disord. 2001 Apr;25(4):512-8. doi: 10.1038/sj.ijo.0801570.

  PMID: 11319655 RESULT

• Smith W, Assink J, Klein R, Mitchell P, Klaver CC, Klein BE, Hofman A, Jensen S, Wang JJ, de Jong PT. Risk factors for age-related macular degeneration: Pooled findings from three continents. Ophthalmology. 2001 Apr;108(4):697-704. doi: 10.1016/s0161-6420(00)00580-7.

  PMID: 11297486 RESULT

• Seddon JM, Cote J, Davis N, Rosner B. Progression of age-related macular degeneration: association with body mass index, waist circumference, and waist-hip ratio. Arch Ophthalmol. 2003 Jun;121(6):785-92. doi: 10.1001/archopht.121.6.785.

  PMID: 12796248 RESULT

• Cho E, Seddon JM, Rosner B, Willett WC, Hankinson SE. Prospective study of intake of fruits, vegetables, vitamins, and carotenoids and risk of age-related maculopathy. Arch Ophthalmol. 2004 Jun;122(6):883-92. doi: 10.1001/archopht.122.6.883.

  PMID: 15197064 RESULT

Related Links

• who bmi classification
• nutrition information system

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• F.Gülhan Samur, Ass. Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Sibel Kadayıfçılar, Prof.

  Hacettepe University

  STUDY CHAIR

• Sedat Arslan, RA

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 31, 2017
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: February 20, 2016
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

TU (1)