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

25. März 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

393

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • California
      • Davis, California, Vereinigte Staaten, 95616
        • USDA, Western Human Nutrition Research Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Healthy people in the general population

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Baseline level and change in systemic immune activation following challenge meal
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Baseline level and change in glucose metabolism
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 0, 3, and 6 hours postprandial
Transcriptome RNA sequenced in whole blood
0, 3, and 6 hours postprandial
Genome Wide Association Study (GWAS)
Zeitfenster: 0 hours (fasting)
DNA sequence from whole blood will be analyzed
0 hours (fasting)
General health
Zeitfenster: 0 hours (Fasting)
Clinical chemistry panel and complete blood count
0 hours (Fasting)
Anthropometrics
Zeitfenster: single time point
Height (cm), weight (kg), waist and hip circumference (cm)
single time point
Vital signs
Zeitfenster: single time point
Blood pressure (mmHg), pulse rate (beats per minute) and temperature (degrees F).
single time point
Body composition
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: single time point
The fermentation capacity of microbiota will be measured from a single stool sample
single time point
Gut microbiota pathogen resistance capacity
Zeitfenster: single time point
The pathogen resistance capability of microbiota will be measured from a single stool sample
single time point
Gut inflammation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: single time point
Food frequency questionnaire (FFQ)
single time point
Behavior assessment
Zeitfenster: single time point
Chronic stress questionnaire, food choice questionnaires, and a food preference activity.
single time point
Taste thresholds
Zeitfenster: 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
Zeitfenster: single time point
Spectrophotometric measure of skin pigmentation for assessment of vitamin D status.
single time point
Peripheral arterial tone
Zeitfenster: single time point
Use of the EndoPAT system to measure blood vessel tone.
single time point
Pulmonary function
Zeitfenster: single time point
Forced expiratory lung volume test
single time point
Pulmonary inflammation
Zeitfenster: single time point
Pulmonary inflammation measured as exhaled nitric oxide (NO)
single time point
Executive function
Zeitfenster: single time point
Executive function will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) and Iowa Gambling Task
single time point
Cognitive function
Zeitfenster: single time point
Measured by Wechsler Abbreviated Standard Intelligence test.
single time point
Aerobic fitness assessment
Zeitfenster: single time point
Pulse rate (bpm) and recovery after a 3 min YMCA Step Test
single time point
Submaximal oxygen consumption
Zeitfenster: 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
Zeitfenster: daily, for 7 days
Use of an accelerometer worn on the hip for 7 days
daily, for 7 days
Usual physical activity
Zeitfenster: single time point
Activity recall using a questionnaire
single time point
Heart rate variability and autonomic nerve conductivity
Zeitfenster: single time point
Monitoring of autonomic balance, cardiac performance, and respiratory measurements and activity using MindWare Mobile Impedance Cardiograph.
single time point
Allostatic Load
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2015

Primärer Abschluss (Tatsächlich)

24. Juli 2019

Studienabschluss (Tatsächlich)

24. Juli 2019

Studienanmeldedaten

Zuerst eingereicht

12. Februar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Februar 2015

Zuerst gepostet (Schätzen)

20. Februar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. März 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. März 2021

Zuletzt verifiziert

1. März 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 691654
  • 2032-53000-001-00 (Andere Zuschuss-/Finanzierungsnummer: United States Department of Agriculture)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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