Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Fecal bacteria population
研究概览
简要总结
The objective of this pilot study is to determine the effects of wheat germ (WG) supplementation on gut health and subsequent effects on markers of inflammation and insulin resistance in overweight individuals. WG is a by-product of wheat processing and an excellent source of omega-3 fatty acids, vitamin E, and fiber. A few studies have shown the health benefits of WG including gut modulatory potential, but the prebiotic functions of WG in humans remain in question and warrant further investigation.
详细描述
Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) between 18 to 45 years old regardless of gender will be recruited. They will be randomly assigned to receive two energy balls containing 30 grams of wheat germ or corn meal (control) in a 4-wk randomized controlled pilot trial. The energy balls will contain wheat germ or corn meal, peanut butter, honey and milk. Participants will be asked to consume two energy balls daily for 4 weeks. Anthropometric measures, questionnaires (medical, diet, physical activity and bowel habits), blood and fecal samples will be collected at baseline and at the end of the four week study. The investigator's primary outcome variables will be changes in fecal bacteria, immunoglobulin A, zonulin and short chain fatty acids while secondary outcome variables will be alterations in plasma markers of inflammation and insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will not know their treatment assignment and energy balls will be in an opaque container.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) 18-45 years old
排除标准
- •diagnosed diabetes, heart disease, and cancer tobacco use excessive alcohol use taking mega-doses of antioxidant/vitamin supplements or medications that could interfere with study endpoints such as antibiotics, anti-inflammatory, and glucose-lowering medications major surgery occurring within 6 months pregnant or lactating previous high intake of wheat germ or sensitivity to gluten and wheat products.
结局指标
主要结局
Fecal bacteria population
时间窗: Change from baseline fecal bacteria at 30 days
analyzed by 16sRNA sequencing
Fecal immunoglobulin A
时间窗: Change from baseline fecal immunoglobulin A at 30 days
analyzed by enzyme-linked immunoassay
Fecal zonulin
时间窗: Change from baseline fecal zonulin at 30 days
analyzed by enzyme-linked immunoassay
Fecal short chain fatty acids
时间窗: Change from baseline fecal shortchain fatty acids at 30 days
analyzed by gas chromatography
次要结局
- blood insulin level(Change from baselineblood insulin level at 30 days)
- Blood glucose(Change from baselineblood glucose at 30 days)
- blood glycated hemoglobin(Change from baseline blood glycated hemoglobin at 30 days)
- blood high sensitivity C-reactive protein(Change from baseline blood high sensitivity C-reactive protein at 30 days)