The Effect of Pecans on Biomarkers of Risk for Cardiovascular Disease and Diabetes: A Controlled Feeding Trial in Overweight/Obese Adults With Central Adiposity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in biomarkers of oxidative stress compared with control diet
研究概览
简要总结
The objective of this randomized, controlled feeding study is to investigate the potential health benefits of a pecan-containing diet. The investigators hypothesize the chronic consumption of pecans will improve an array of biomarkers related to cardiovascular disease and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity, inflammation, endothelial function, and insulin resistance when compared with a control diet that is absent nuts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men & postmenopausal women, age 50 years and over
- •BMI 25-35 kg/m2
- •Waist/hip >0.8 for women and >0.9 for men
- •Blood pressure between 120/80 and 159/99
排除标准
- •Cigarette smoking and/or nicotine replacement use
- •Individuals taking estrogen
- •Use of cholesterol-lowering medications
- •Use of blood pressure-lowering medications
- •Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications (prescription or over-the-counter [OTC])
- •Cardiovascular (heart) disease
- •Gastrointestinal disease
- •Kidney disease
- •Endocrine disease: including diabetes, unstable thyroid disease
- •Autoimmune disease: including rheumatoid arthritis, gout, lupus, HIV
- •Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
- •Systolic blood pressure > 159 mmHg and/or diastolic blood pressure > 99 mmHg
- •Regular use of oral or injectable steroids
- •Gain or loss of > 10% of body weight within previous 3 months; unwillingness to maintain your weight
- •Regular daily intake of ≥ 2 alcoholic drinks
- •Vegetarians
- •Current allergy to any kind of nut
- •Dietary supplement use, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
研究组 & 干预措施
Pecan-containing diet
Test diet containing 1.5 oz pecans/2000 kcal/day for 28 days
干预措施: Pecan-containing diet (Other)
Nut-free diet
Placebo diet containing no nuts or nut products, and identical in total fat and fiber as the test diet, for 28 days
干预措施: Nut-free diet (Other)
结局指标
主要结局
Change in biomarkers of oxidative stress compared with control diet
时间窗: Baseline and 4 weeks
Change in biomarkers of inflammation compared with control diet
时间窗: Baseline and 4 weeks.
Change in biomarkers of endothelial function compared with control diet
时间窗: Baseline and 4 weeks.
Change in biomarkers of antioxidant activity compared with control diet
时间窗: Baseline and 4 weeks
Change in biomarkers of insulin resistance compared with control diet
时间窗: Baseline and 4 weeks
次要结局
- Change in blood pressure compared with control diet(Baseline and 4 weeks)
- Change in plasma lipid profile compared with control diet(Baseline and 4 weeks.)