Measuring Single-Serving Grain Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Identification of unknown biomarkers of grain intake immediately after grain consumption
研究概览
简要总结
The primary objective of this study is to identify markers of a single meal of whole grain oat and whole grain wheat intake in humans.
详细描述
The aim of this study is to identify compounds that are found in blood and urine and are derived from a single meal of whole grain oat or whole grain wheat intake so that epidemiological studies can be conducted to provide more accurate associations between whole grain intake and health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 to 75 years of age
- •Voluntarily agree to participate and sign an informed consent form
排除标准
- •Body weight less than 110 lbs.
- •Have a body mass index below 19 or above 38 kg/m2
- •Known (self-reported) allergy or adverse reaction to study foods
- •Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study
- •History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study
- •History of certain cancer diagnosis or treatment in the last 3 years
- •Smoking or use of tobacco products in the past 6 months
- •Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- •Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
- •Unable or unwilling to give informed consent or communicate with study staff
- •Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
研究组 & 干预措施
Whole Grain Oat
Volunteers will consume a breakfast meal containing whole grain oats after 7 days of a whole grain free diet.
干预措施: Whole grain oats (Other)
Whole Grain Wheat
Volunteers will consume a breakfast meal containing whole grain wheat after 7 days of a whole grain free diet.
干预措施: Whole grain wheat (Other)
结局指标
主要结局
Identification of unknown biomarkers of grain intake immediately after grain consumption
时间窗: Day 34
Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
Identification of unknown biomarkers of grain intake a day after grain consumption
时间窗: Day 35
Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
Identification of unknown biomarkers of grain intake 2 days after grain consumption
时间窗: Day 36
Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
次要结局
- Blood glucose(Days 8 and 34)
- Serum insulin(Days 8 and 34)
- Serum c-peptide(Days 8 and 34)
- Non-esterified fatty acids in blood(Days 8 and 34)
- Triglycerides in blood(Days 8 and 34)
研究者
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center