Mediterranean Diet and Mushrooms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Change in perceived quality of life from baseline to post-intervention
研究概览
简要总结
The investigators propose to assess the effects of including mushrooms as part of a healthy eating pattern on indices of perceived mental health/anxiety/depression, along with risk factors for cardiovascular disease and type 2 diabetes.
详细描述
The investigators hypothesize that consuming mushrooms as part of a healthy eating pattern will lead to greater improvements in fasting insulin concentrations and systolic and diastolic blood pressures. The brain health-related outcomes and other cardiometabolic risk outcomes (e.g. lipoprotein particle size) are exploratory due to the paucity of human research addressing these important topics. Collectively, this short-term (8-week) randomized, controlled feeding trial will provide important pilot data to inform the plausibility, focus, and design of longer-term intervention trials, consistent with The Mushroom Council's research agenda.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female;
- •age 30-69 y;
- •BMI: 25.0-34.9 kg/m2;
- •Not severely or extremely depressed (Beck's Depression Inventory score ≤30)
- •Total cholesterol <240 mg/dL, low-density lipoprotein cholesterol <160 mg/dL, triglycerides <400 mg/dL, fasting glucose <110 mg/dL;
- •Systolic/diastolic blood pressure <140/90 mm Hg;
- •Body weight stable for 3 months prior (± 3 kg);
- •Stable physical activity regimen 3 months prior;
- •Medication use stable for 6 months prior;
- •Non-smoking;
- •Non-diabetic;
- •Not acutely ill;
- •Females not pregnant or lactating;
- •Participants must be willing and able to consume the prescribed diets and travel to testing facilities.
排除标准
- •BMI <25 or >35;
- •Severely depressed (Beck's Depression Inventory score >30);
- •Total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160 mg/dL, triglycerides >400 mg/dL, fasting glucose >110 mg/dL;
- •Body weight changes in previous 3 months (±3 kg);
- •Changes in physical activity regimen in the previous 3 months;
- •Medication changes in the previous 6 months;
- •Diabetic;
- •Acute illness;
- •Pregnant or lactating;
- •Allergic to mushrooms
结局指标
主要结局
Change in perceived quality of life from baseline to post-intervention
时间窗: 8 weeks
Medical Outcomes Study 36-Item Short Form Health Survey Version 2
Change in perceived anxiety from baseline to post-intervention
时间窗: 8 weeks
General Anxiety Disorder-7 questionnaire
Change in perceived daily mood from baseline to post-intervention
时间窗: 8 weeks
Profile of Mood States
Change in cognitive function from baseline to post-intervention
时间窗: 8 weeks
Repeatable Battery for the Assessment of Neuropsychological Status
Risk factors for type 2 diabetes
时间窗: 8 weeks
Complete metabolic panel
Change in perceived depression from baseline to post-intervention
时间窗: 8 weeks
Beck's Depression Inventory questionnaire
Risk factors for cardiovascular disease
时间窗: 8 weeks
Blood pressure
Change in immunity/inflammation markers
时间窗: 8 weeks
Complete Cytokine 13 Panel -- all outcomes reported as pg/mL
次要结局
- Body weight(8 weeks)
- Gut microbiota(8 weeks)
研究者
Wayne Campbell
Principal Investigator
Purdue University