Effects of Goji Berry Intake on Risk of Age-related Macular Degeneration: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Macular pigment optical volume (MPOV)
研究概览
简要总结
The goal of this project is to conduct a clinical trial in 60 participants ranging from age 65-95 who are at risk for age-related macular degeneration (AMD). The study will evaluate the effects of 14g of goji berry intake or an equivalent amount and type of fiber, five days a week for six months, on visual health, gut microbiome profiles, skin carotenoid measures, and lipoprotein profiles.
详细描述
Age-related macular degeneration (AMD) is the third leading cause of blindness worldwide. The disease occurs when the macula in the central retina develops lesions due, in part, to the loss of the protection of macular pigments zeaxanthin, lutein, and meso-zeaxanthin, which are responsible for light filtering and oxidative defense. The major risk factor for AMD is aging, and currently, no definitive prevention for AMD exists.
Goji berry (Lycium Barbarum) is a fruit that has been used as traditional medicine in Asian countries for more than 2,000 years. Modern science has identified potential benefits of the berry in oxidant defense, immune regulation, diabetes, and vision in animal and cell models. Nonetheless, evidence regarding the effects of goji berries on human health is scarce. The bioactive components of goji berries include zeaxanthin, lutein, Lycium Barbarum polysaccharides-protein complex, betaine, cerebroside, minerals, and vitamins. Importantly, goji berries contain the highest concentration of zeaxanthin among all commonly consumed foods.
Previous clinical studies have shown that goji berries have a high bioavailability of zeaxanthin, and that macular pigment optical density (MPOD) was increased after supplementation. This study uses macular pigment optical volume (MPOV; a measure that integrates MPOD across multiple macular eccentricities) as the primary outcome measure. It is unknown if the changes in MPOV will be associated with other functional changes or anatomic conditions in the eye among a population with small drusen, a risk factor for AMD. In addition, the impact of goji berry intake on the gut microbiome profile and associated metabolites is unknown, and potentially important in understanding the mechanism(s) of action.
Participants who meet the eligibility criteria will be enrolled and will be randomized 1:1 to the goji berry arm or fiber arm of the study. Over the course of approximately 180 days, participants will consume the assigned food item five days per week and attend three study visits.
Study visits will include ophthalmic imaging and testing, skin carotenoid measurements, completion of a food record, height, weight, handgrip strength, blood pressure measurement, and fasting blood collection. At 2 timepoints participants will be asked to provide a stool sample (collected within 24 hours of visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family history of AMD
- •Hyperlipidemia or managed diabetes
- •65 - 95 years of age
排除标准
- •Dislike of, or allergy to, goji berries or any of the ingredients in the fiber-rich wafers and gummies (wheat, corn, oats, soy, natural orange flavor, xylitol, annatto, pectin, or other food ingredients)
- •Consumption of > 2 alcoholic drinks per day
- •Indications of substance or alcohol abuse
- •Current or planned use of a blood thinner (e.g., Coumadin, Warfarin) at any time during study
- •Use of multi-vitamin or any other supplements that contain lutein and/or zeaxanthin (if willing to stop the supplement, subject can be enrolled 6 months from stop date)
- •Taking any new medications started within the past 6 months, or changes in medication regimen planned in the next 6 months (stable use greater than 6 months is not exclusionary)
- •Any planned international travel during the study
- •Consuming >3 servings/day of a combination of spinach, kale, lettuce, orange bell peppers, corn, parsley, squash, broccoli, pumpkin, edamame
- •Regularly consuming >3 eggs/day
- •Currently participating in any other interventional research study
- •Diagnosed with inflammatory bowel disease, irritable bowel syndrome, other gastrointestinal disorder, undergoing cancer therapy or immunocompromised, or diagnosis of another condition where lutein, zeaxanthin and/or fiber supplementation would be contraindicated or would interfere with ability to participate in the study
- •Any physical characteristic or condition that precludes ability to perform study procedures
- •Medical or psychiatric condition that, in the opinion of the Investigator, would compromise study findings or prevent the participant from completing the study
研究组 & 干预措施
Fiber
For the fiber arm, participants will consume fiber supplements that closely matches the fiber type and amount found in the portion of goji berries.
干预措施: Fiber (Dietary Supplement)
Goji berry
For the goji berry arm, participants will consume goji berries.
干预措施: Goji berry (Dietary Supplement)
结局指标
主要结局
Macular pigment optical volume (MPOV)
时间窗: Day 0 and Day 180
MPOV provides an objective measure of macular pigments by using dual wavelength autofluorescence using the Heidelberg Spectralis to obtain HRA + OCT measures
次要结局
- Handgrip strength(Day 0 and Day 180)
- Stool microbiome(Day 0 and Day 180)
- Peripheral blood mononuclear cells (PBMC) gene expression changes(Day 0 and Day 180)
- Dark adaptometry(Day 0 and Day 180)
- Plasma microbial metabolites(Day 0 and Day 180)
- Lipoprotein profile(Day 0 and Day 180)
- Cognitive function(Day 0 and Day 180)
- Fundus autofluorescence (FAF)(Day 0 and Day 180)
- Color Fundus Photography (CFP)(Day 0 and Day 180)
- Microperimetry testing(Day 0 and Day 180)
- HDL particle characteristics(Day 0 and Day 180)
- Spectral Domain-Ocular Coherence Tomography (SD-OCT)(Day 0 and Day 180)
- Plasma lutein and zeaxanthin(Day 0 and Day 180)
研究者
Robert Hackman, PhD
Research Nutritionist
University of California, Davis