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

NCT02367287 | Completed

• 2 other identifiers: 6916542032-53000-001-00
• Study Type: observational
• Target: 393
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Inflammation

Keywords

Diet; Phenotype; Immunology; Microbiota; Metabolomics; Physical activity; Neuroendocrine system; Nutritional Physiological Phenomena

Outcome Measures

Primary Outcomes (2)

• Baseline level and change in systemic immune activation following challenge meal

  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

  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

Secondary Outcomes (39)

• Baseline level and change in glucose metabolism

  0, 0.5, 3, and 6 hours postprandial

• Baseline level and change in appetitive hormones

  0, 0.5, 3, and 6 hours postprandial

• Baseline level and change in mitogen activated protein (MAP) kinase activity

  0, 0.5, 3 and 6 hours postprandial

• Baseline level and change in dietary-responsive, circulating microRNA

  0, 0.5, 3, and 6 hours postprandial

• Baseline level and change in RNA transcriptome

  0, 3, and 6 hours postprandial

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy people in the general population

You may qualify if:

• Male or female
• Body Mass Index 18.5-45.0 kg/m2 (Normal to obese)

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Study Sites (1)

USDA, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (30)

• Wopereis S, Wolvers D, van Erk M, Gribnau M, Kremer B, van Dorsten FA, Boelsma E, Garczarek U, Cnubben N, Frenken L, van der Logt P, Hendriks HF, Albers R, van Duynhoven J, van Ommen B, Jacobs DM. Assessment of inflammatory resilience in healthy subjects using dietary lipid and glucose challenges. BMC Med Genomics. 2013 Oct 27;6:44. doi: 10.1186/1755-8794-6-44.

  PMID: 24160467 BACKGROUND

• Pellis L, van Erk MJ, van Ommen B, Bakker GC, Hendriks HF, Cnubben NH, Kleemann R, van Someren EP, Bobeldijk I, Rubingh CM, Wopereis S. Plasma metabolomics and proteomics profiling after a postprandial challenge reveal subtle diet effects on human metabolic status. Metabolomics. 2012 Apr;8(2):347-359. doi: 10.1007/s11306-011-0320-5. Epub 2011 May 28.

  PMID: 22448156 BACKGROUND

• Krug S, Kastenmuller G, Stuckler F, Rist MJ, Skurk T, Sailer M, Raffler J, Romisch-Margl W, Adamski J, Prehn C, Frank T, Engel KH, Hofmann T, Luy B, Zimmermann R, Moritz F, Schmitt-Kopplin P, Krumsiek J, Kremer W, Huber F, Oeh U, Theis FJ, Szymczak W, Hauner H, Suhre K, Daniel H. The dynamic range of the human metabolome revealed by challenges. FASEB J. 2012 Jun;26(6):2607-19. doi: 10.1096/fj.11-198093. Epub 2012 Mar 16.

  PMID: 22426117 BACKGROUND

• Robles Alonso V, Guarner F. Linking the gut microbiota to human health. Br J Nutr. 2013 Jan;109 Suppl 2:S21-6. doi: 10.1017/S0007114512005235.

  PMID: 23360877 BACKGROUND

• Baldiviez LM, Keim NL, Laugero KD, Hwang DH, Huang L, Woodhouse LR, Burnett DJ, Zerofsky MS, Bonnel EL, Allen LH, Newman JW, Stephensen CB. Design and implementation of a cross-sectional nutritional phenotyping study in healthy US adults. BMC Nutr. 2017 Oct 19;3:79. doi: 10.1186/s40795-017-0197-4. eCollection 2017.

  PMID: 32153856 BACKGROUND

• Oliver A, Alkan Z, Stephensen CB, Newman JW, Kable ME, Lemay DG. Diet, Microbiome, and Inflammation Predictors of Fecal and Plasma Short-Chain Fatty Acids in Humans. J Nutr. 2024 Nov;154(11):3298-3311. doi: 10.1016/j.tjnut.2024.08.012. Epub 2024 Aug 20.

  PMID: 39173973 RESULT

• James KL, Gertz ER, Kirschke CP, Allayee H, Huang L, Kable ME, Newman JW, Stephensen CB, Bennett BJ. Trimethylamine N-Oxide Response to a Mixed Macronutrient Tolerance Test in a Cohort of Healthy United States Adults. Int J Mol Sci. 2023 Jan 20;24(3):2074. doi: 10.3390/ijms24032074.

  PMID: 36768394 RESULT

• Riazati N, Kable ME, Newman JW, Adkins Y, Freytag T, Jiang X, Stephensen CB. Associations of microbial and indoleamine-2,3-dioxygenase-derived tryptophan metabolites with immune activation in healthy adults. Front Immunol. 2022 Sep 29;13:917966. doi: 10.3389/fimmu.2022.917966. eCollection 2022.

  PMID: 36248784 RESULT

• Chin EL, Huang L, Bouzid YY, Kirschke CP, Durbin-Johnson B, Baldiviez LM, Bonnel EL, Keim NL, Korf I, Stephensen CB, Lemay DG. Association of Lactase Persistence Genotypes (rs4988235) and Ethnicity with Dairy Intake in a Healthy U.S. Population. Nutrients. 2019 Aug 10;11(8):1860. doi: 10.3390/nu11081860.

  PMID: 31405126 RESULT

• Bouzid YY, Arsenault JE, Bonnel EL, Cervantes E, Kan A, Keim NL, Lemay DG, Stephensen CB. Effect of Manual Data Cleaning on Nutrient Intakes Using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). Curr Dev Nutr. 2021 Feb 2;5(3):nzab005. doi: 10.1093/cdn/nzab005. eCollection 2021 Mar.

  PMID: 33763626 RESULT

• Lemay DG, Baldiviez LM, Chin EL, Spearman SS, Cervantes E, Woodhouse LR, Keim NL, Stephensen CB, Laugero KD. Technician-Scored Stool Consistency Spans the Full Range of the Bristol Scale in a Healthy US Population and Differs by Diet and Chronic Stress Load. J Nutr. 2021 Jun 1;151(6):1443-1452. doi: 10.1093/jn/nxab019.

  PMID: 33704458 RESULT

• Arrington CE, Tacad DKM, Allayee H, Sutton KJ, Dombroski C, Keim NL, Newman JW, Bennett BJ. Genetic determinants of BMI, diet, and fitness interact to partially explain anthropometric obesity traits but not the metabolic consequences of obesity in men and women. Int J Obes (Lond). 2026 Feb 20. doi: 10.1038/s41366-026-02027-0. Online ahead of print.

  PMID: 41720915 RESULT

• Blecksmith SE, Oliver A, Alkan Z, Lemay DG. Gut Microbiome Genes Involved in Plant and Mucin Breakdown Correlate with Diet and Gastrointestinal Inflammation in Healthy United States Adults. J Nutr. 2025 Nov;155(11):3757-3768. doi: 10.1016/j.tjnut.2025.08.027. Epub 2025 Sep 1.

  PMID: 40902732 RESULT

• Tang Y, Oliver A, Alkan Z, Korf I, Huang L, Kable ME, Lemay DG. Association of lactose intake and lactase persistence genotype with microbial taxa and function in healthy multi-ethnic U.S. adults. Food Funct. 2025 Sep 15;16(18):7393-7407. doi: 10.1039/d5fo01640a.

  PMID: 40880079 RESULT

• Tacad DKM, Borkowski K, Keim NL. Differential associations of eating behavior traits, food preference, motivations of food choice on diet intake and diet quality in adult females and males from the USDA nutritional phenotyping study. Appetite. 2025 Sep 1;213:108048. doi: 10.1016/j.appet.2025.108048. Epub 2025 May 7.

  PMID: 40339649 RESULT

• Stephensen CB, Jiang X, Gale B, Peerson JM. Association of Healthy Eating Index-2015 Total and Component Scores with Measures of Inflammation and Immune Activation in Healthy Adults. J Nutr. 2025 Mar;155(3):994-1004. doi: 10.1016/j.tjnut.2025.01.005. Epub 2025 Jan 7.

  PMID: 39788323 RESULT

• Riazati N, Engle-Stone R, Stephensen CB. Association of Vitamin D Status with Immune Markers in a Cohort of Healthy Adults. J Nutr. 2025 Feb;155(2):621-633. doi: 10.1016/j.tjnut.2024.12.010. Epub 2024 Dec 21.

  PMID: 39716659 DERIVED

• Wilson SM, Oliver A, Larke JA, Naveja JJ, Alkan Z, Awika JM, Stephensen CB, Lemay DG. Fine-Scale Dietary Polyphenol Intake Is Associated with Systemic and Gastrointestinal Inflammation in Healthy Adults. J Nutr. 2024 Nov;154(11):3286-3297. doi: 10.1016/j.tjnut.2024.08.010. Epub 2024 Aug 18.

  PMID: 39163972 DERIVED

• Bouzid YY, Wilson SM, Alkan Z, Stephensen CB, Lemay DG. Lower Diet Quality Associated with Subclinical Gastrointestinal Inflammation in Healthy United States Adults. J Nutr. 2024 Apr;154(4):1449-1460. doi: 10.1016/j.tjnut.2024.02.030. Epub 2024 Mar 1.

  PMID: 38432562 DERIVED

• Kable ME, Chin EL, Huang L, Stephensen CB, Lemay DG. Association of Estimated Daily Lactose Consumption, Lactase Persistence Genotype (rs4988235), and Gut Microbiota in Healthy Adults in the United States. J Nutr. 2023 Aug;153(8):2163-2173. doi: 10.1016/j.tjnut.2023.06.025. Epub 2023 Jun 23.

  PMID: 37354976 DERIVED

• Snodgrass RG, Jiang X, Stephensen CB, Laugero KD. Cumulative physiological stress is associated with age-related changes to peripheral T lymphocyte subsets in healthy humans. Immun Ageing. 2023 Jun 23;20(1):29. doi: 10.1186/s12979-023-00357-5.

  PMID: 37353855 DERIVED

• Larke JA, Bacalzo N, Castillo JJ, Couture G, Chen Y, Xue Z, Alkan Z, Kable ME, Lebrilla CB, Stephensen CB, Lemay DG. Dietary Intake of Monosaccharides from Foods is Associated with Characteristics of the Gut Microbiota and Gastrointestinal Inflammation in Healthy US Adults. J Nutr. 2023 Jan;153(1):106-119. doi: 10.1016/j.tjnut.2022.12.008. Epub 2022 Dec 26.

  PMID: 36913444 DERIVED

• Snodgrass RG, Jiang X, Stephensen CB. Monocyte subsets display age-dependent alterations at fasting and undergo non-age-dependent changes following consumption of a meal. Immun Ageing. 2022 Sep 14;19(1):41. doi: 10.1186/s12979-022-00297-6.

  PMID: 36104734 DERIVED

• Wang YE, Kirschke CP, Woodhouse LR, Bonnel EL, Stephensen CB, Bennett BJ, Newman JW, Keim NL, Huang L. SNPs in apolipoproteins contribute to sex-dependent differences in blood lipids before and after a high-fat dietary challenge in healthy U.S. adults. BMC Nutr. 2022 Sep 1;8(1):95. doi: 10.1186/s40795-022-00592-x.

  PMID: 36050800 DERIVED

• Newman JW, Krishnan S, Borkowski K, Adams SH, Stephensen CB, Keim NL. Assessing Insulin Sensitivity and Postprandial Triglyceridemic Response Phenotypes With a Mixed Macronutrient Tolerance Test. Front Nutr. 2022 May 11;9:877696. doi: 10.3389/fnut.2022.877696. eCollection 2022.

  PMID: 35634390 DERIVED

• Oliver A, Xue Z, Villanueva YT, Durbin-Johnson B, Alkan Z, Taft DH, Liu J, Korf I, Laugero KD, Stephensen CB, Mills DA, Kable ME, Lemay DG. Association of Diet and Antimicrobial Resistance in Healthy U.S. Adults. mBio. 2022 Jun 28;13(3):e0010122. doi: 10.1128/mbio.00101-22. Epub 2022 May 10.

  PMID: 35536006 DERIVED

• Kable ME, Chin EL, Storms D, Lemay DG, Stephensen CB. Tree-Based Analysis of Dietary Diversity Captures Associations Between Fiber Intake and Gut Microbiota Composition in a Healthy US Adult Cohort. J Nutr. 2022 Mar 3;152(3):779-788. doi: 10.1093/jn/nxab430.

  PMID: 34958387 DERIVED

• Chin EL, Van Loan M, Spearman SS, Bonnel EL, Laugero KD, Stephensen CB, Lemay DG. Machine Learning Identifies Stool pH as a Predictor of Bone Mineral Density in Healthy Multiethnic US Adults. J Nutr. 2021 Nov 2;151(11):3379-3390. doi: 10.1093/jn/nxab266.

  PMID: 34313764 DERIVED

• Artegoitia VM, Krishnan S, Bonnel EL, Stephensen CB, Keim NL, Newman JW. Healthy eating index patterns in adults by sex and age predict cardiometabolic risk factors in a cross-sectional study. BMC Nutr. 2021 Jun 22;7(1):30. doi: 10.1186/s40795-021-00432-4.

  PMID: 34154665 DERIVED

• Mo Z, Huang S, Burnett DJ, Rutledge JC, Hwang DH. Endotoxin May Not Be the Major Cause of Postprandial Inflammation in Adults Who Consume a Single High-Fat or Moderately High-Fat Meal. J Nutr. 2020 May 1;150(5):1303-1312. doi: 10.1093/jn/nxaa003.

  PMID: 32040591 DERIVED

Related Links

• WHNRC website

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, stool

MeSH Terms

Conditions

Obesity; Inflammation; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Behavior

Study Officials

• Charles B Stephensen, Ph.D.

  USDA, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

• Brian J Bennett, Ph.D.

  USDA, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 20, 2015
• Study Start: May 1, 2015
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)