Effects of Freeze-dried Grape Powder on Immune Profiles in Healthy Aging Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Concentration of lipopolysaccharide (LPS)-induced interleukin-1 beta (IL-1beta) secreted from subject-derived primary immune cells ex vivo
研究概览
简要总结
The purpose of this study is to investigate the effects of consuming grape powder on immune profiles in healthy middle- and older-aged individuals. Specifically, the investigators are interested in evaluating the potential effects of grapes in influencing markers of immune function, inflammation, and metabolism that are known to change with aging. Grapes contain several nutrients and antioxidant polyphenols such as resveratrol, quercetin, vitamin K and fiber, which are known to promote heart and immune health. However, the effects of grapes on altering immune profiles within the context of aging is not well understood. Therefore, this study will explore how daily grape consumption impacts certain markers of immunity in healthy middle- and older-aged adults.
The main study procedures include consumption of a freeze-dried grape powder and control powder (which tastes the same but has none of the grape compounds that are being studied) mixed with water as a beverage on a daily basis for 4 weeks each. The investigators will additionally ask that participants avoid eating grapes and certain other antioxidant/grape-related foods and beverages throughout the 13-week study. Participants will additionally be asked to complete surveys about their diet, physical activity, and medical history, as well as provide blood samples and body weight measures throughout the course of the study. Participation in the study is expected to last about 6.25 hours over the course of 13 weeks and will include 7 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-75 years old (at time of screening)
- •Body mass index (BMI) 18.5 to < 30 kg/m2
- •Willing to consume grape and control powder during study periods, and refrain from eating grapes and certain other polyphenol-rich foods and beverages during the study
- •Do not fit any
排除标准
- •Exclusion Criteria:
- •<50 years old and >75 years old
- •BMI <18.5 and ≥ 30 kg/m2 or body weight < 110 pounds
- •Experienced >10% weight change in the past 4 weeks
- •Elevated fasting glucose levels (fasting glucose higher than 126 mg/dL) and triglycerides greater than 500 mg/dL
- •Self-reported and/or physician-diagnosed history of diabetes mellitus, coronary heart disease, stroke, renal or liver disease, cancer, eating disorders, certain severe and/or relapsing/remitting autoimmune, inflammatory, or metabolic diseases, chronic infections, scleroderma, blood clotting disorders, intravenous drug use, or current pregnancy or lactation
- •Allergy to grapes or any ingredients in the grape or control powders
- •Implanted medical device (e.g., pacemaker) or other health condition that would prevent measurement of body composition by bioelectrical impedance
- •Currently taking lipid-lowering medications (e.g., statins, fibrates), glucose-regulating medications, anti-inflammatory medications (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids), or medications that primarily affect blood clotting (e.g., warfarin), long-term antibiotics in the last 3 months, active use of probiotics during the intervention
- •Active smoker
研究组 & 干预措施
Freeze-dried whole grape powder
干预措施: Freeze-dried whole grape powder (Other)
Control grape-free powder
干预措施: Control grape-free powder (Other)
结局指标
主要结局
Concentration of lipopolysaccharide (LPS)-induced interleukin-1 beta (IL-1beta) secreted from subject-derived primary immune cells ex vivo
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Catherine Andersen
Associate Professor
University of Connecticut