Effects of Dairy Fat on Postprandial Inflammation- Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasma inflammatory mediators
研究概览
简要总结
Phase 2 of this study involves determining how consumption of cheese compared with a non-dairy cheese substitute influences inflammation over a six hour period.
详细描述
Phase 2 is a randomized crossover study designed to determine how consumption of cheese compared with a non-dairy cheese substitute influences postprandial inflammation in participants who have 2 or more risk factors of metabolic syndrome or BMI ≥ 30.
Eligible participants will arrive to the Western Human Nutrition Research Center (WHNRC) at the University of California (UC) Davis campus on the morning of each test day after a 10-12-hr overnight fast. Upon arrival participants will fill out a questionnaire about their dietary and medication intakes and physical activity for the past 72 hours to ensure compliance. Compliant participants' weight and blood pressure will be measured and a fasting blood draw will be taken before participants consume their test meal (cheese or non-dairy cheese substitute). Participants will only consume this test meal and water freely for the duration of the test day. Blood will be drawn serially at 1, 3 and 6 hours postprandially. Participants will be tested on a second test day two weeks after the first test.
On the second test day, participants' body composition and bone mineral density will be measured by dual x-ray absorptiometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •Two or more components of metabolic syndrome:
- •Central obesity (waist circumference greater than 40 inches for men and 35 inches for women); fasting blood triglycerides greater than or equal to 150 mg/dL; plasma HDL cholesterol (Less than 40 mg/dL for men and less than 50 mg/dL for women); blood pressure greater than or equal to 130/85 mmHg; fasting glucose greater than or equal to 100 mg/dL
- •- BMI equal to or greater than 30
排除标准
- •Metabolic Disorders:
- •BMI > 40
- •Body weight more than 400 lbs.
- •Any immune related diseases such as autoimmune disease, rheumatoid arthritis, asthma,
- •Gastrointestinal disorders including Crohn's Disease, colitis, diverticulitis, irritable bowel disease, celiac, malabsorption syndrome
- •Known presence of significant metabolic disease which could impact the results of the study (i.e. hepatic, renal disease)
- •Type II diabetes
- •Use of over-the-counter anti-obesity agents (e.g. containing phenylpropanolamine, ephedrine, and/or caffeine) within the last 12 weeks
- •Use of corticoid steroids within the last 12 weeks
- •Daily use of anti-inflammatory pain medication
- •Self report of eating disorder
- •Poor vein assessment determined by WHNRC's phlebotomist
- •Dietary/supplements:
- •Known allergy or intolerance to study food (lactose intolerance, dairy, wheat allergies)
- •Vegetarian (defined as abstinence from consumption of eggs, dairy, poultry, beef and pork)
- •More than 1 serving of fish per week
- •More than 14 grams of fiber per 1000 kcal per day
- •Less than 16:1 of total dietary omega 6: Omega 3 ratio
- •More than 1% of daily energy as trans fats
- •Initiation of anti-inflammatory supplemental fish, krill, flax, borage and primrose seed oils within the last 12 weeks
- •Dietary supplements consisting of concentrated soy isoflavones, resveratrol, other polyphenols identified as modulators of inflammation Medications
- •Initiation of statin therapy within the last 12 weeks Lifestyle
- •More than 10% weight loss or gain during the past 6 months
- •Recent initiation (past 4 weeks) of exercise program
- •Plan to become pregnant in the next 6 months
- •Pregnancy or lactation
- •Recent initiation or cessation of hormonal birth control or change in hormonal birth control regimen within the last 12 weeks
- •Use of tobacco products
- •More than 2 standard alcoholic drinks per day.
结局指标
主要结局
Plasma inflammatory mediators
时间窗: 0, 1, 3, 6 hr postprandial
Plasma cytokines will be measured using a multi-plex immunoassay and plasma oxylipins will be measured by mass spectroscopy.
次要结局
- Plasma lipid profile(0, 1, 3, 6 hours postprandial)
- Urinary metabolites(0, 1, 3, 6 hours postprandial)
- Plasma glucose(0, 1, 3, 6 hours postprandial)
- Red blood cell functionality(0, 1, 3, 6 hours postprandial)
- Plasma bone markers(0, 1, 3, 6 hours postprandial)
- Plasma lipoprotein size distribution(0, 1, 3, 6 hours postprandial)