NCT02367287

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

Completed Last updated 20 March 2026

What this trial tests

trial in Obesity in 393 participants. Completed in 24 July 2019.

Timeline

1 May 2015

Primary endpoint
24 July 2019

24 July 2019

Quick facts

Lead sponsor	USDA, Western Human Nutrition Research Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	393
Start date	1 May 2015
Primary completion	24 July 2019
Estimated completion	24 July 2019
Sites	1 location across United States

Conditions studied

• Obesity — all drugs for Obesity →
• Inflammation — all drugs for Inflammation →

Sponsor

USDA, Western Human Nutrition Research Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity or Inflammation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Baseline level and change in systemic immune activation following challenge meal
  Time frame: 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.
• Baseline level and change in plasma metabolome
  Time frame: 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of Conventional and Atypical MAPKs on the Development of Metabolic Diseases.
   Kassouf T, Sumara G. · · 2020 · cited 69× · PMID 32872540 · DOI 10.3390/biom10091256
2. Association of Diet and Antimicrobial Resistance in Healthy U.S. Adults.
   Oliver A, Xue Z, Villanueva YT, Durbin-Johnson B, et al · · 2022 · cited 68× · PMID 35536006 · DOI 10.1128/mbio.00101-22
3. Design and implementation of a cross-sectional nutritional phenotyping study in healthy US adults.
   Baldiviez LM, Keim NL, Laugero KD, Hwang DH, et al · · 2017 · cited 37× · PMID 32153856 · DOI 10.1186/s40795-017-0197-4
4. Tree-Based Analysis of Dietary Diversity Captures Associations Between Fiber Intake and Gut Microbiota Composition in a Healthy US Adult Cohort.
   Kable ME, Chin EL, Storms D, Lemay DG, et al · · 2022 · cited 33× · PMID 34958387 · DOI 10.1093/jn/nxab430
5. Dietary Intake of Monosaccharides from Foods is Associated with Characteristics of the Gut Microbiota and Gastrointestinal Inflammation in Healthy US Adults.
   Larke JA, Bacalzo N, Castillo JJ, Couture G, et al · · 2023 · cited 27× · PMID 36913444 · DOI 10.1016/j.tjnut.2022.12.008
6. Association of Lactase Persistence Genotypes (rs4988235) and Ethnicity with Dairy Intake in a Healthy U.S. Population.
   Chin EL, Huang L, Bouzid YY, Kirschke CP, et al · · 2019 · cited 24× · PMID 31405126 · DOI 10.3390/nu11081860
7. Associations of microbial and indoleamine-2,3-dioxygenase-derived tryptophan metabolites with immune activation in healthy adults.
   Riazati N, Kable ME, Newman JW, Adkins Y, et al · · 2022 · cited 23× · PMID 36248784 · DOI 10.3389/fimmu.2022.917966
8. Nutrient Estimation from 24-Hour Food Recalls Using Machine Learning and Database Mapping: A Case Study with Lactose.
   Chin EL, Simmons G, Bouzid YY, Kan A, et al · · 2019 · cited 21× · PMID 31847188 · DOI 10.3390/nu11123045