The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
The Western diet pattern or standard American diet is a modern dietary pattern that is characterized by high intakes of meat, pre-packaged foods, fried foods, high-fat dairy products, eggs, refined grains etc. When considering the role of saturated fat, it may be prudent to advise limiting all foods that contain saturated fats, including unprocessed/minimally processed meat, eggs, whole dairy in addition to processed, pre-packaged foods; however, this reductionist approach fails to take into account the food matrix and overall diet in which these nutrients are consumed.
Epidemiological evidence suggests that increased modern, pre-packaged food consumption is a major risk factor for metabolic disease by promoting inflammation. Based on these data, the investigators hypothesize that the pro-atherogenic effect of the Western diet is caused by the pro-inflammatory effects of consuming large amounts of modern ultra-processed foods, and that consumption of a similar amount of fat from minimally processed beef, poultry, dairy, eggs, as part of an unprocessed diet will positively impact inflammatory markers and lipoprotein profiles of study participants when compared to a diet rich in modern ultra-processed foods.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27701
- Duke University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥35 and ≤60 years;
- BMI ≥25 and ≤35 kg/m2;
- Weight stable in last 3 months (Loss or gain <4%);
- Consistent physical activity levels;
- Hemoglobin A1C (HbA1C) ≤6.4%;
- Fasting insulin; <15 µU/mL;
- Fasting plasma glucose concentration <126 mg/dl;
- Willingness to eat the food provided in this study;
- Subjects must be able to speak and understand English to participate in this study
- Own a smartphone or other mobile device capable of downloading the Garmin Connect app.
Exclusion Criteria:
- Diagnoses of active malignancy, congestive heart failure, diabetes mellitus, chronic obstructive pulmonary disease, thyroid disease or other metabolic disorders that influence metabolism;
- Evidence of impaired kidney function (Estimated glomerular filtration rate [eGFR] <44 mL/min;
- Regular use of medication that interferes with the measurement of study outcomes as determined by the study team (e.g., NSAIDs, corticosteroids);
- Consuming >14 drinks per week of >4 drinks per night twice/week for male; >7 drinks per week or >3 drinks per night twice/week for female;
- Use of cigarettes (or other tobacco products) or use of any other (recreational) drug in last 3 months;
- Engaged in high-level competitive exercise (e.g., marathons, triathlons, cycling, weight-lifting competitions etc.)
- Self-reported sleep duration <5 hours per night;
- Any inflammatory diseases (e.g. asthma, autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, arthritis);
- Use of antibiotics in last 30 days;
- Pregnant or lactating women;
- Eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge eating disorders etc.)
- Psychological disorders (e.g., clinical depression, bipolar disorders etc.);
- Strict dietary patterns (e.g., vegan, carnivore, kosher, low-carb etc.);
- History of stomach or bowel resection (other than appendectomy), gastric bypass or other bariatric weight loss procedure effecting absorption;
- Persons who are not able to grant voluntary informed consent;
- Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Traditional Diet
Unprocessed/minimally processed whole foods.
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Consuming an traditional whole foods based diet for 4 weeks.
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有源比较器:Modern Diet
Multi-ingredient, ultra-processed formulations of the traditional diet.
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Consuming an processed formulation of the traditional diet for 4 weeks.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in plasma interleukin-6 levels
大体时间:Baseline, up to 4 weeks.
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Plasma interleukin-6 levels will be measured before and after each diet
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Baseline, up to 4 weeks.
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Change in plasma c-reactive protein levels
大体时间:Baseline, up to 4 weeks.
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Plasma c-reactive protein levels levels will be measured before and after each diet
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Baseline, up to 4 weeks.
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Change in plasma acylcarnitine profiles
大体时间:Baseline, up to 4 weeks.
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Plasma acylcarnitines profiles levels will be measured before and after each diet
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Baseline, up to 4 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in gut microbiota communities
大体时间:Baseline, up to 4 weeks.
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Bifidobacterium, Faecalibacterium prausnitzii, Anerostipes, Roseburia
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Baseline, up to 4 weeks.
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Energy expenditure
大体时间:up to 4 weeks.
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Measured by the doubly labeled water method during the last week of each diet
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up to 4 weeks.
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Change in Neuroinflammation
大体时间:Baseline, up to 4 weeks.
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Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß42 and p-tau will be measured before and after each diet
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Baseline, up to 4 weeks.
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合作者和调查者
调查人员
- 研究主任:Stephan van Vliet, PhD、Duke University
- 首席研究员:Kim Huffman, MD, PhD、Duke University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Pro00103827
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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Traditional Diet的临床试验
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Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital System招聘中
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University of CalgaryStewart Diabetes Education Fund完全的