Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in serum 25-hydroxy-vitamin D2 concentration
研究概览
简要总结
We propose to assess the effects of including vitamin D-enriched mushrooms as part of participants' usual eating pattern primarily on 25(OH) vitamin D2 status and secondarily on immune function and inflammatory status.
详细描述
We hypothesize that consuming vitamin D-enriched mushrooms daily for 12 weeks will prevent decreases in serum 25-hydroxy-vitamin D2 concentrations. Secondarily, we hypothesize consuming vitamin D-enriched mushrooms daily for 12 weeks will improve clinical indicators of inflammatory status and alter/enhance immune status and immune cell function. This short-term randomized, controlled trial will provide important data to inform the plausibility, focus, and design of longer-term intervention trials, consistent with The Mushroom Council's research agenda regarding health-promoting effects of vitamin D-enriched mushrooms.
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
- •BMI: 25.0-34.9 kg/m^2
- •Total cholesterol <240 mg/dL
- •low density lipoprotein cholesterol < 160 mg/dL
- •triglycerides <300 mg/dL
- •fasting glucose < 110 mg/dL
- •systolic/diastolic blood pressure < 140/90 mmHg
- •body weight stable for 3 months prior (+- 3 kg)
- •stable physical activity regiment 3 months prior
- •medication use stable for 6 months prior
- •non-smoking
- •non-diabetic
- •not acutely ill
- •females not pregnant or lactating
- •willing to refrain from taking vitamin D supplements or any supplements containing vitamin D
- •No history of bariatric surgery
- •Not extremely or severely depressed (Beck's Depression Inventory Score <= 30)
- •Agree not to donate blood for at least one month prior to, during, and for one month after the study
- •Agree not to travel to sunny locations during the study period
- •Agree to forgo any tanning bed or other tanning procedures during the study
- •Willing and able to consume mushrooms and travel to testing facilities
排除标准
- •Age <30 or >70
- •BMI <25 or >35kg/m2
- •Total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160 mg/dL, triglycerides >300mg/dL, fasting glucose >110 mg/dL
- •Systolic/diastolic blood pressure >140/90 mm Hg
- •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
- •Extremely or severely depressed (Beck's Depression Inventory Score >30)
- •Unwilling to refrain from taking vitamin D supplements or any supplements containing vitamin D
- •Regiment of megadosing vitamin D
- •Unwilling to not to travel to sunny locations during the study period
- •Unwilling to forgo any tanning bed or other tanning procedures during the study
- •History of bariatric surgery
- •Consuming a restricted diet (such as keto, gluten free, high protein, low carb, etc.)
- •Acute illness
- •Females pregnant or lactating
- •Unwilling to not to donate blood for at least one month prior to, during, and for one month after the study
- •Allergic to mushrooms or bread
结局指标
主要结局
Change in serum 25-hydroxy-vitamin D2 concentration
时间窗: 12 weeks
25(OH) Vitamin D2/D3 by LC/MS
次要结局
- Change in perceived anxiety from baseline to mid to post-intervention(12 weeks)
- Body weight(12 weeks)
- Change in bone remodeling(12 weeks)
- Change in serum calcium concentrations(12 weeks)
- Change in perceived daily mood from baseline to mid to post-intervention(12 weeks)
- Change in perceived quality of life from baseline to mid to post-intervention(12 weeks)
- Change in perceived depression from baseline to mid to post-intervention(12 weeks)
- Change in cognitive function from baseline to mid to post-intervention(12 weeks)
- Risk factors for type 2 diabetes(12 weeks)
- Change in immunity/inflammation markers(12 weeks)
- Risk factors for cardiovascular disease(12 weeks)
研究者
Wayne Campbell
Principal Investigator
Purdue University