Almonds to Improve Gut Health and Decrease Inflammation in Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Gut permeability and health: Short chain fatty acids
研究概览
简要总结
Almonds are a good source of beneficial compounds. This study will investigate if eating almonds everyday for 12 weeks can affect gut health and inflammation in persons with metabolic syndrome. Investigators will measure changes in metabolism, heart health, and the levels of vitamins and other compounds from almonds.
详细描述
Metabolic Syndrome (MetS) affects over a billion people world-wide. MetS progression and further health complications are driven by chronic inflammation. Major causes of inflammation in MetS are gut barrier breakdown and the absorption of harmful bacteria. What causes the gut barrier breakdown is not clear, but a poor diet, especially low micronutrient intakes like vitamin E, is implicated by propagating a vicious cycle that promotes oxidative stress, inflammation and further gut barrier damage. This study will assess the impact of daily consumption of 2 ounces of almonds for 12 weeks on gut health, markers of inflammation and cardiometabolic health, and micronutrient status in persons with MetS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35-60 years
- •3 or more of the following: hypertension (systolic BP 130-179 mmHg or diastolic BP 85-119 mmHg); hyperglycemia (fasting glucose 100-599 mg/dL); central obesity [waist circumference greater than 40.1 inches (M) or 34.6 inches (F); hypertriglyceridemia (150-499 mg/dL); low HDL [lower than 40 mg/dL (M) or 50 mg/dL (F)]
- •Willing to restrict consumption of nuts other than study nuts for 1 week prior to and throughout the study (13 weeks)
- •Willing to stop probiotic supplements one week prior to and during the study (13 weeks)
- •Willing to stop multivitamins and supplements containing vitamin E, magnesium, calcium, iron, zinc and copper one week prior to and during the study (13 weeks)
- •Willing to complete intake diaries during the study
- •Willing to maintain current eating patterns (no significant diet change during study)
排除标准
- •Weekly consumption of almonds, hazelnuts, peanuts and sunflower seeds combined greater than 2 servings (about 2 oz) in the past 3 months
- •Nut, wheat, or gluten allergy/intolerance
- •Regular use of vitamin E supplements
- •Consume more than 2 alcoholic drinks daily
- •Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past 3 months
- •Pregnancy, breastfeeding, or planning to become pregnant before completing the study
- •Vigorous exercise greater than 7 hours/week
- •History of cardiovascular disease, liver disease or cancer
- •Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedures (e.g. cholecystectomy), disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis) or chronic diarrhea
- •Diagnosis of hemochromatosis
- •Chronic use (daily intake in past 30 days) of anti-inflammatory medication (steroid or NSAID)
- •Use of ezetimibe or orlistat
- •Use of oral antibiotic medication within the past month
- •Body Mass Index (BMI) <25.0 or >35.0 kg/m2
- •Regular use of multivitamin supplements in the past 3 months
- •Physician prescribed use of probiotic, vitamin E, magnesium, calcium, iron, zinc or copper supplements
研究组 & 干预措施
Almonds
Daily consumption of 2 ounces of unsalted, dry roasted almonds for 12 weeks
干预措施: Almond (Other)
Crackers
Daily consumption of non-whole grain crackers for 12 weeks (caloric equivalent to 2 ounces of dry roasted almonds)
干预措施: Crackers (Other)
结局指标
主要结局
Gut permeability and health: Short chain fatty acids
时间窗: 0 and 4 weeks
Change from baseline at week 4: Markers of gut barrier function and health fecal short chain fatty acids profiles
Oxidative stress status: isoprostanes
时间窗: 0 and 4 weeks
Change from baseline at week 4: Urinary isoprostanes
Cardiometabolic health
时间窗: 0 and 12 weeks
Change from baseline at week 12: Total cholesterol, LDL, HDL, and triglycerides
Gut permeability and health: Inflammatory biomarkers
时间窗: 0 and 4 weeks
Change from baseline at week 4: Gut inflammatory biomarkers calprotectin and myeloperoxidase
Biomarkers of inflammation
时间窗: 0 and 4 weeks
Change from baseline at week 4: Plasma inflammatory markers (ex. TNF and IL-6)
Vitamin E status
时间窗: 0, 4 and 12 weeks
Change from baseline at week 4 and week 12: Plasma α-tocopherols
Vitamin E status: Urinary catabolite
时间窗: 0, 4 and 12 weeks
Change from baseline at week 4 and week 12: Urinary vitamin E catabolite (α-CEHC)
Gut permeability and health: Serum endotoxin
时间窗: 0 and 4 weeks
Change from baseline at week 4: Marker of gut barrier function and health, serum endotoxin
Oxidative stress status: malondialdehyde
时间窗: 0 and 4 weeks
Change from baseline at week 4: Plasma malondialdehyde
次要结局
- BMI(0, 4 and 12 weeks)
- Waist circumference(0, 4 and 12 weeks)
- Mineral status(0 and 12 weeks)
- Glycemic control: glucose(0 and 12 weeks)
- Blood pressure(0, 4 and 12 weeks)
- Weight(0, 4 and 12 weeks)
- Glycemic control: HOMA-IR(0 and 12 weeks)
- Glycemic control: Insulin(0 and 12 weeks)
- Other almond-based bioactives (polyphenol levels)(0 and 12 weeks)
研究者
Laura Beaver
Research Associate
Oregon State University