Assessment of Systematic Health Properties of Pecan Nut Consumption: Gut, Vascular, Metabolic and Cognitive Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in vascular response at 3 months
研究概览
简要总结
The main goal of this clinical study is to see if consuming pecan nuts will result in improvements in overall body metabolism such as in blood lipids, markers of inflammation, blood pressure, cognitive performance and changes in bacteria living in the gut in adults 45 to 75 years of age.
Participants will take part in two 3-month intervention periods, separated by 4-6 weeks, in random order ( a total of approximately 7 months). During one intervention period, they will include pecan nuts in their diet each day, while during the other intervention period they will avoid pecans in their diet. There will be an initial screening visit to evaluate eligibility and four study visits to the clinic.
Participants will be asked to complete some questionnaires about their diet, physical and cognitive health, and provide blood and stool samples, and have their blood pressure measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 20-35 kg/m2, ability to understand the intervention instructions, Willingness to follow the dietary intervention, Willingness to provide biological samples (blood and stool) -
排除标准
- •Allergy to pecan or other nuts, Cognitive impairment due to dementia of any type and inability to understand or comply with intervention instructions, Use of menopausal hormone replacement therapy, Use of antibiotics or probiotics in the 2 months prior to enrollment, Uncontrolled diabetes with HbA1C of >9.5, Vegetarian/vegan, Any serious medical condition (such as chronic kidney disease of stage 3 or greater, heart failure, active cancer treatment, inflammatory bowel disease, etc.), Consumption of supplements that may interfere with vascular response or gut microbiome, Use of statin drugs for cholesterol lowering.
研究组 & 干预措施
Pecan nut then no nut
Participant will add pecan nuts to their diet during the first intervention arm, then they will cross over to the no nut diet arm
干预措施: pecan nut (Other)
No nut then pecan nut
Participant will consume a diet without nuts during the first intervention arm, then they will cross over to the arm where they will add pecan nuts to their diet.
干预措施: pecan nut (Other)
结局指标
主要结局
Change in vascular response at 3 months
时间窗: Change from baseline at 3 months
Vascular response as measured by Pulse Wave Velocity (PWV)
次要结局
- Change in blood acute phase inflammatory response maker at 3 months(Change from baseline at 3 months)
- Change in blood lipids over 3 months(Change from baseline at 3 months)
- Change in markers of inflammation at 3 months(change from baseline at 3 months)
- Change in gut microbiome profile at 3 months(Change from baseline at 3 months)
- Change in blood markers of intestinal permeability at 3 months.(Change from baseline at 3 months)
- Change in blood markers of intestinal permeability at 3 months(Change from baseline at 3 months)
- Change in cognitive function - reaction time at 3 months(Change from baseline at 3 months)
- Change in cognitive function - working memory at 3 months(Change from baseline at 3 months)
- Change in cognitive function - episodic memory at 3 months(Change from baseline to 3 months)
- Change in cognitive function - sustained attention at 3 months(Change from baseline at 3 months)
- Change in quality of life at 3 months(Change from baseline at 3 months)
- Change in sleep quality at 3 months(Change from baseline at 3 months)
- Change in mood over 3 months(Change from baseline to 3 months)
- Change in perceived stress over 3 months(Change from baseline at 3 months)
- Change in anxiety at 3 months(Change from baseline at 3 months)
- Change in depressive symptoms at 3 months(Change from baseline at 3 months)
研究者
Francene Steinberg
Professor
University of California, Davis