USDA Western Human Nutrition Research Center (WHNRC) Cross-Sectional Nutritional Phenotyping Study
الكلمات الدالة
نبذة مختصرة
وصف
Many inflammatory responses can be modulated by specific dietary components. For example, in cardiovascular disease, macrophages and T-cells react with oxidized LDL (an endogenous modified antigen) to produce arterial plaque and subsequent blockage of coronary arteries. High intake of saturated fats (or simple sugars that drive synthesis of saturated fatty acids) may promote this inflammation by affecting macrophages and T-cells. Conversely, increased intake of omega-3 fatty acids may decrease inflammation by suppression of macrophage and T-cell pro-inflammatory activity. Long-term sub-clinical inflammation caused by intestinal bacteria has been linked to the development of Irritable Bowel Disease and related disorders. Low intake of fruits, vegetables, or whole grains or high intake of saturated fats may promote sub-clinical gut inflammation by promoting dysbiosis of the gut microbiota. Allergic asthma develops in predisposed individuals as a result of an overactive allergic-type immune response to inhaled environmental allergens. Dietary factors such as vitamin D and omega-3 fatty acids may diminish pro-inflammatory responses to environmental allergens by promoting the development of T-regulatory cells and other anti-inflammatory factors.
Individual variability in chronic disease risk is well recognized. For example, why does excess adiposity lead to disease in some individuals and not others? The nature of the fat tissue rather than the abundance, may impact cross-talk with other metabolically-relevant tissues and affect disease risk. It is important to characterize healthy vs. unhealthy phenotypes across various tissues and to understand how micro- and macro-nutrients interact with molecular and metabolic pathways to support a healthy body weight. This study brings together scientists with expertise in nutritional sciences, immunology, analytical chemistry, physiology, neuroendocrinology, and behavior to understand how diet impacts metabolism and disease risk through the interplay and coordination of signals and metabolites arising from multiple organ systems.
The overall objective is to characterize the phenotypic profile of participants according to their immunologic, physiologic, neuroendocrine, and metabolic responses to a dietary challenge and a physical fitness challenge by addressing the specific aims listed below. The cross-sectional study is organized into two study visits (Visit 1 and Visit 2) separated by approximately two weeks of at-home specimen and data collection.
Specific Aim 1: To determine if diet quality is independently associated with systemic immune activation, inflammation, or oxidative stress differentiated by:
1. pro-inflammatory T-helper cells (Th1, Th2, and Th17 cells) and related cytokines
2. anti-inflammatory T-regulatory cells and related cytokines
3. dysbiosis of the gut microbiota and markers of gut inflammation (e.g. neopterin and myeloperoxidase)
a. and to evaluate the association between dysbiosis of the gut microbiota, gut inflammation, and systemic immune activation
4. plasma metabolomic response to a mixed macronutrient challenge meal (includes diet quality and physical activity as independent variables)
5. endothelial (dys)function and vascular reactivity
Specific Aim 2: To determine if a high fat/sugar challenge meal induces differential effects over time (0-6h postprandial) according to habitual diet characteristics, physical activity levels, stress levels, age, sex, or BMI on:
1. postprandial monocyte activation
2. plasma lipid metabolomic responses including non-esterified fatty acids, phospholipids, triacylglycerols, red blood cell fatty acids, endocannabinoids, bile acids, eicosanoids and related oxylipins, ceramides, sphingoid bases, and acylcarnitines
3. plasma amino acid metabolomics
4. glucose metabolism and metabolic flexibility (i.e. the ability to switch from glucose to lipid oxidation as energy sources)
5. changes in endocrinology and self-report of hunger and satiety
6. postprandial free cortisol
Specific Aim 3: To determine the mechanisms of:
1. postprandial monocyte activation
2. suppression of challenge-meal induced monocyte activation by docosahexaenoic acid (DHA) (in an ex vivo experiment using a subset of samples)
Specific Aim 4: To evaluate the associations between eating behavior, physical activity, and/or anthropometry and the outcomes:
1. endocrinology of hunger and satiety
2. plasma metabolomic responses
3. vulnerability and resistance to stress
4. endothelial (dys)function and vascular reactivity
5. prediction of insulin sensitivity
Specific Aim 5: To determine how genetic variants affect nutrient metabolism, cardiovascular physiology, and immune function and improve understanding of how dietary factors affect these metabolic, cardiovascular and immune phenotypes.
تواريخ
آخر التحقق: | 10/31/2019 |
تم الإرسال لأول مرة: | 02/11/2015 |
تم إرسال التسجيل المقدر: | 02/18/2015 |
أول نشر: | 02/19/2015 |
تم إرسال آخر تحديث: | 11/05/2019 |
آخر تحديث تم نشره: | 11/11/2019 |
تاريخ بدء الدراسة الفعلي: | 04/30/2015 |
تاريخ الإنجاز الأساسي المقدر: | 07/23/2019 |
التاريخ المتوقع لانتهاء الدراسة: | 07/23/2019 |
حالة أو مرض
مرحلة
مجموعات الذراع
ذراع | التدخل / العلاج |
---|---|
Sampling strata Stratified analyses of primary and secondary outcomes based on variables of interest (e.g. sex, age, or BMI) may occur prior to achieving the target for total study enrollment. |
معايير الأهلية
الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
الأجناس المؤهلة للدراسة | All |
طريقة أخذ العينات | Non-Probability Sample |
يقبل المتطوعين الأصحاء | نعم |
المعايير | Inclusion Criteria: - 18-65 y - Male or female - Body Mass Index 18.5-45.0 kg/m2 (Normal to obese) Exclusion Criteria: - Pregnant or lactating women - Known allergy to egg-white protein - Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg measured on three separate occasions - Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to: - Diabetes mellitus - Cardiovascular disease - Cancer - Gastrointestinal disorders - Kidney disease - Liver disease - Bleeding disorders - Asthma - Autoimmune disorders - Hypertension - Osteoporosis - Recent minor surgery (within 4 wk) or major surgery (within 16 wk) - Recent antibiotic therapy (within 4 wk) - Recent hospitalization (within 4 wk) - Use of prescription medications at the time of the study that directly affect endpoints of interest (e.g. hyperlipidemia, glycemic control, steroids, statins, anti-inflammatory agents, and over-the-counter weight loss aids) |
النتيجة
مقاييس النتائج الأولية
1. Baseline level and change in systemic immune activation following challenge meal [0, 0.5, 3, and 6 hours postprandial]
2. Baseline level and change in plasma metabolome [0, 0.5, 3, and 6 hours postprandial]
مقاييس النتائج الثانوية
1. Baseline level and change in glucose metabolism [0, 0.5, 3, and 6 hours postprandial]
2. Baseline level and change in appetitive hormones [0, 0.5, 3, and 6 hours postprandial]
3. Baseline level and change in mitogen activated protein (MAP) kinase activity [0, 0.5, 3 and 6 hours postprandial]
4. Baseline level and change in dietary-responsive, circulating microRNA [0, 0.5, 3, and 6 hours postprandial]
5. Baseline level and change in RNA transcriptome [0, 3, and 6 hours postprandial]
6. Genome Wide Association Study (GWAS) [0 hours (fasting)]
7. General health [0 hours (Fasting)]
8. Anthropometrics [single time point]
9. Vital signs [single time point]
10. Body composition [single time point]
11. Resting and change in metabolism [0, 0.5, 3, and 6 hours postprandial]
12. Gut microbiota [single time point]
13. Gut microbiota fermentation capacity [single time point]
14. Gut microbiota pathogen resistance capacity [single time point]
15. Gut inflammation [single time point]
16. Stool metabolites [single time point]
17. Stool RNA markers [single time point]
18. Baseline and change in hunger and appetite [0, 1, 2, 3, 4, 5, and 6 hours postprandial]
19. Baseline and change in gut fermentation profile [0, 1, 2, 3, 4, 5, and 6 hours postprandial]
20. Recent dietary intake [Three 24-hour dietary recalls collected at home]
21. Dietary intake [single time point]
22. Behavior assessment [single time point]
23. Taste thresholds [single time point]
24. Skin reflectance [single time point]
25. Peripheral arterial tone [single time point]
26. Pulmonary function [single time point]
27. Pulmonary inflammation [single time point]
28. Executive function [single time point]
29. Cognitive function [single time point]
30. Aerobic fitness assessment [single time point]
31. Submaximal oxygen consumption [single time point]
32. Physical activity [daily, for 7 days]
33. Usual physical activity [single time point]
34. Heart rate variability and autonomic nerve conductivity [single time point]
35. Allostatic Load [single time point]
36. Baseline and change in salivary cortisol in response to test meal [0, immediately post-prandial, 30, 60, and 90 minutes post-prandial]
37. Baseline and change in salivary cortisol in response to exercise [0, immediately post-exercise, 30, 60, and 90 minutes post-exercise]
38. Baseline and change in salivary cortisol in response to emotional recall task [0, immediately post-task, 30, 60, and 90 minutes post-task]
39. Baseline and change in breath aldehydes [0, 1, 4 and 6 hours postprandial]