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USDA Western Human Nutrition Research Center (WHNRC) Cross-Sectional Nutritional Phenotyping Study

25 de marzo de 2021 actualizado por: USDA, Western Human Nutrition Research Center

Assessing the Impact of Diet on Inflammation in Healthy and Obese Adults in a Cross-Sectional Phenotyping Study

Although the diet of the US population meets or exceeds recommended intake levels of most essential nutrients, the quality of the diet consumed by many Americans is sub-optimal due to excessive intake of added sugars, solid fats, refined grains, and sodium. The foundations and outcomes of healthy vs. unhealthy eating habits and activity levels are complex and involve interactions between the environment and innate physiologic/genetic background. For instance, emerging research implicates chronic and acute stress responses and perturbations in the Hypothalamic-Pituitary-Adrenal axis in triggering obesity-promoting metabolic changes and poor food choices. In addition, the development of many chronic diseases, including cardiovascular disease, diabetes, cancer, asthma and autoimmune disease, results from an overactive immune response to host tissue or environmental antigens (e.g. inhaled allergens). A greater understanding is needed of the distribution of key environment-physiology interactions that drive overconsumption, create positive energy balance, and put health at risk.

Researchers from the United States Department of Agriculture (USDA) Western Human Nutrition Research Center are conducting a cross-sectional "metabolic phenotyping" study of healthy people in the general population. Observational measurements include the interactions of habitual diet with the metabolic response to food intake, production of key hormones, the conversion of food into energy: the metabolism of fats, proteins, and carbohydrates, characteristics of the immune system, stress response, gut microbiota (bacteria in the intestinal tract), and cardiovascular health. Most outcomes will be measured in response to a mixed macronutrient/high fat challenge meal.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

393

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • Davis, California, Estados Unidos, 95616
        • USDA, Western Human Nutrition Research Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Healthy people in the general population

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline level and change in systemic immune activation following challenge meal
Periodo de tiempo: 0, 0.5, 3, and 6 hours postprandial
Number and activation level of pro-inflammatory T-helper (Th) cells (Th1, Th2 and Th17), T-regulatory (Treg) cells, and B cells will be measured in fasting blood. Monocytes and neutrophils will be measured in fasting and postprandial blood.
0, 0.5, 3, and 6 hours postprandial
Baseline level and change in plasma metabolome
Periodo de tiempo: 0, 0.5, 3, and 6 hours postprandial
Plasma fatty acid profiles of non-esterified fatty acids, phospholipids, triacylglycerols, red blood cell fatty acids, endocannabinoids, bile acids, eicosanoids and related oxylipins, ceramides, sphingoid bases, acylcarnitines, amino acids and other metabolites measured in response to a challenge meal.
0, 0.5, 3, and 6 hours postprandial

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline level and change in glucose metabolism
Periodo de tiempo: 0, 0.5, 3, and 6 hours postprandial
Glucose and insulin measured in response to a challenge meal.
0, 0.5, 3, and 6 hours postprandial
Baseline level and change in appetitive hormones
Periodo de tiempo: 0, 0.5, 3, and 6 hours postprandial
Cholecystokinin, incretins, Peptide YY 3-36, ghrelin measured in response to a challenge meal.
0, 0.5, 3, and 6 hours postprandial
Baseline level and change in mitogen activated protein (MAP) kinase activity
Periodo de tiempo: 0, 0.5, 3 and 6 hours postprandial
Mononuclear cells or B cells will be measured for MAP kinase activities in fasting and postprandial blood.
0, 0.5, 3 and 6 hours postprandial
Baseline level and change in dietary-responsive, circulating microRNA
Periodo de tiempo: 0, 0.5, 3, and 6 hours postprandial
Plasma microRNA measured in response to a challenge meal
0, 0.5, 3, and 6 hours postprandial
Baseline level and change in RNA transcriptome
Periodo de tiempo: 0, 3, and 6 hours postprandial
Transcriptome RNA sequenced in whole blood
0, 3, and 6 hours postprandial
Genome Wide Association Study (GWAS)
Periodo de tiempo: 0 hours (fasting)
DNA sequence from whole blood will be analyzed
0 hours (fasting)
General health
Periodo de tiempo: 0 hours (Fasting)
Clinical chemistry panel and complete blood count
0 hours (Fasting)
Anthropometrics
Periodo de tiempo: single time point
Height (cm), weight (kg), waist and hip circumference (cm)
single time point
Vital signs
Periodo de tiempo: single time point
Blood pressure (mmHg), pulse rate (beats per minute) and temperature (degrees F).
single time point
Body composition
Periodo de tiempo: single time point
Body composition (percent body fat) and bone mineral density by Dual energy X-ray Absorptiometry scan.
single time point
Resting and change in metabolism
Periodo de tiempo: 0, 0.5, 3, and 6 hours postprandial
Resting and postprandial metabolic rates, including respiratory exchange ratios.
0, 0.5, 3, and 6 hours postprandial
Gut microbiota
Periodo de tiempo: single time point
Gut microbiota composition and gene content will be assessed in stool using polymerase chain reaction (PCR) and sequencing
single time point
Gut microbiota fermentation capacity
Periodo de tiempo: single time point
The fermentation capacity of microbiota will be measured from a single stool sample
single time point
Gut microbiota pathogen resistance capacity
Periodo de tiempo: single time point
The pathogen resistance capability of microbiota will be measured from a single stool sample
single time point
Gut inflammation
Periodo de tiempo: single time point
Gut inflammation will be assessed by measuring molecules in stool and/or the response of intestinal epithelial cell cultures to fecal waters from a single stool sample.
single time point
Stool metabolites
Periodo de tiempo: single time point
Volatile and short chain fatty acids and bile acids will be measured in a single stool sample.
single time point
Stool RNA markers
Periodo de tiempo: single time point
RNA markers will provide a measure of genes expressed by cells of the colon naturally present in a single stool sample
single time point
Baseline and change in hunger and appetite
Periodo de tiempo: 0, 1, 2, 3, 4, 5, and 6 hours postprandial
Perceived hunger and fullness will be measured using a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 5 or "extremely."
0, 1, 2, 3, 4, 5, and 6 hours postprandial
Baseline and change in gut fermentation profile
Periodo de tiempo: 0, 1, 2, 3, 4, 5, and 6 hours postprandial
Breath hydrogen and methane measured in response to a challenge meal.
0, 1, 2, 3, 4, 5, and 6 hours postprandial
Recent dietary intake
Periodo de tiempo: Three 24-hour dietary recalls collected at home
Random selection of 2 week days and 1 weekend day for 24-hour recall using an automated multi-pass method
Three 24-hour dietary recalls collected at home
Dietary intake
Periodo de tiempo: single time point
Food frequency questionnaire (FFQ)
single time point
Behavior assessment
Periodo de tiempo: single time point
Chronic stress questionnaire, food choice questionnaires, and a food preference activity.
single time point
Taste thresholds
Periodo de tiempo: single time point
Sampling tastes of sweet, salty, and bitter solutions in comparison to water to determine threshold of taste detection.
single time point
Skin reflectance
Periodo de tiempo: single time point
Spectrophotometric measure of skin pigmentation for assessment of vitamin D status.
single time point
Peripheral arterial tone
Periodo de tiempo: single time point
Use of the EndoPAT system to measure blood vessel tone.
single time point
Pulmonary function
Periodo de tiempo: single time point
Forced expiratory lung volume test
single time point
Pulmonary inflammation
Periodo de tiempo: single time point
Pulmonary inflammation measured as exhaled nitric oxide (NO)
single time point
Executive function
Periodo de tiempo: single time point
Executive function will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) and Iowa Gambling Task
single time point
Cognitive function
Periodo de tiempo: single time point
Measured by Wechsler Abbreviated Standard Intelligence test.
single time point
Aerobic fitness assessment
Periodo de tiempo: single time point
Pulse rate (bpm) and recovery after a 3 min YMCA Step Test
single time point
Submaximal oxygen consumption
Periodo de tiempo: single time point
The submaximal volume of oxygen consumed during a 4 minute treadmill walking protocol (VO2max) (ml/kg*min)
single time point
Physical activity
Periodo de tiempo: daily, for 7 days
Use of an accelerometer worn on the hip for 7 days
daily, for 7 days
Usual physical activity
Periodo de tiempo: single time point
Activity recall using a questionnaire
single time point
Heart rate variability and autonomic nerve conductivity
Periodo de tiempo: single time point
Monitoring of autonomic balance, cardiac performance, and respiratory measurements and activity using MindWare Mobile Impedance Cardiograph.
single time point
Allostatic Load
Periodo de tiempo: single time point
An aggregate score derived from measures of urinary cortisol, norepinephrine, epinephrine, blood cholesterol, high sensitivity c-reactive protein, and hemoglobin A1C.
single time point
Baseline and change in salivary cortisol in response to test meal
Periodo de tiempo: 0, immediately post-prandial, 30, 60, and 90 minutes post-prandial
Salivary cortisol measured by enzyme-linked immunosorbent assay (ELISA)
0, immediately post-prandial, 30, 60, and 90 minutes post-prandial
Baseline and change in salivary cortisol in response to exercise
Periodo de tiempo: 0, immediately post-exercise, 30, 60, and 90 minutes post-exercise
Salivary cortisol measured by enzyme-linked immunosorbent assay (ELISA)
0, immediately post-exercise, 30, 60, and 90 minutes post-exercise
Baseline and change in salivary cortisol in response to emotional recall task
Periodo de tiempo: 0, immediately post-task, 30, 60, and 90 minutes post-task
Salivary cortisol measured by enzyme-linked immunosorbent assay (ELISA)
0, immediately post-task, 30, 60, and 90 minutes post-task
Baseline and change in breath aldehydes
Periodo de tiempo: 0, 1, 4 and 6 hours postprandial
The concentration of aldehydes present in human breath before and after a high-fat meal will be measured by mass spectrometry
0, 1, 4 and 6 hours postprandial

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Charles B Stephensen, Ph.D., USDA, Western Human Nutrition Research Center
  • Investigador principal: Brian J Bennett, Ph.D., USDA, Western Human Nutrition Research Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2015

Finalización primaria (Actual)

24 de julio de 2019

Finalización del estudio (Actual)

24 de julio de 2019

Fechas de registro del estudio

Enviado por primera vez

12 de febrero de 2015

Primero enviado que cumplió con los criterios de control de calidad

19 de febrero de 2015

Publicado por primera vez (Estimar)

20 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de marzo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

25 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 691654
  • 2032-53000-001-00 (Otro número de subvención/financiamiento: United States Department of Agriculture)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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