Obesity Clinical Trial
Official title:
Assessing the Impact of Diet on Inflammation in Healthy and Obese Adults in a Cross-Sectional Phenotyping Study
Verified date | March 2021 |
Source | USDA, Western Human Nutrition Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 393 |
Est. completion date | July 24, 2019 |
Est. primary completion date | July 24, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | USDA, Western Human Nutrition Research Center | Davis | California |
Lead Sponsor | Collaborator |
---|---|
USDA, Western Human Nutrition Research Center |
United States,
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Baseline level and change in glucose metabolism | Glucose and insulin measured in response to a challenge meal. | 0, 0.5, 3, and 6 hours postprandial | |
Secondary | Baseline level and change in appetitive hormones | Cholecystokinin, incretins, Peptide YY 3-36, ghrelin measured in response to a challenge meal. | 0, 0.5, 3, and 6 hours postprandial | |
Secondary | Baseline level and change in mitogen activated protein (MAP) kinase activity | 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 | |
Secondary | Baseline level and change in dietary-responsive, circulating microRNA | Plasma microRNA measured in response to a challenge meal | 0, 0.5, 3, and 6 hours postprandial | |
Secondary | Baseline level and change in RNA transcriptome | Transcriptome RNA sequenced in whole blood | 0, 3, and 6 hours postprandial | |
Secondary | Genome Wide Association Study (GWAS) | DNA sequence from whole blood will be analyzed | 0 hours (fasting) | |
Secondary | General health | Clinical chemistry panel and complete blood count | 0 hours (Fasting) | |
Secondary | Anthropometrics | Height (cm), weight (kg), waist and hip circumference (cm) | single time point | |
Secondary | Vital signs | Blood pressure (mmHg), pulse rate (beats per minute) and temperature (degrees F). | single time point | |
Secondary | Body composition | Body composition (percent body fat) and bone mineral density by Dual energy X-ray Absorptiometry scan. | single time point | |
Secondary | Resting and change in metabolism | Resting and postprandial metabolic rates, including respiratory exchange ratios. | 0, 0.5, 3, and 6 hours postprandial | |
Secondary | Gut microbiota | Gut microbiota composition and gene content will be assessed in stool using polymerase chain reaction (PCR) and sequencing | single time point | |
Secondary | Gut microbiota fermentation capacity | The fermentation capacity of microbiota will be measured from a single stool sample | single time point | |
Secondary | Gut microbiota pathogen resistance capacity | The pathogen resistance capability of microbiota will be measured from a single stool sample | single time point | |
Secondary | Gut inflammation | 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 | |
Secondary | Stool metabolites | Volatile and short chain fatty acids and bile acids will be measured in a single stool sample. | single time point | |
Secondary | Stool RNA markers | RNA markers will provide a measure of genes expressed by cells of the colon naturally present in a single stool sample | single time point | |
Secondary | Baseline and change in hunger and appetite | 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 | |
Secondary | Baseline and change in gut fermentation profile | Breath hydrogen and methane measured in response to a challenge meal. | 0, 1, 2, 3, 4, 5, and 6 hours postprandial | |
Secondary | Recent dietary intake | 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 | |
Secondary | Dietary intake | Food frequency questionnaire (FFQ) | single time point | |
Secondary | Behavior assessment | Chronic stress questionnaire, food choice questionnaires, and a food preference activity. | single time point | |
Secondary | Taste thresholds | Sampling tastes of sweet, salty, and bitter solutions in comparison to water to determine threshold of taste detection. | single time point | |
Secondary | Skin reflectance | Spectrophotometric measure of skin pigmentation for assessment of vitamin D status. | single time point | |
Secondary | Peripheral arterial tone | Use of the EndoPAT system to measure blood vessel tone. | single time point | |
Secondary | Pulmonary function | Forced expiratory lung volume test | single time point | |
Secondary | Pulmonary inflammation | Pulmonary inflammation measured as exhaled nitric oxide (NO) | single time point | |
Secondary | Executive function | Executive function will be assessed using Cambridge Neuropsychological Test Automated Battery (CANTAB) and Iowa Gambling Task | single time point | |
Secondary | Cognitive function | Measured by Wechsler Abbreviated Standard Intelligence test. | single time point | |
Secondary | Aerobic fitness assessment | Pulse rate (bpm) and recovery after a 3 min YMCA Step Test | single time point | |
Secondary | Submaximal oxygen consumption | The submaximal volume of oxygen consumed during a 4 minute treadmill walking protocol (VO2max) (ml/kg*min) | single time point | |
Secondary | Physical activity | Use of an accelerometer worn on the hip for 7 days | daily, for 7 days | |
Secondary | Usual physical activity | Activity recall using a questionnaire | single time point | |
Secondary | Heart rate variability and autonomic nerve conductivity | Monitoring of autonomic balance, cardiac performance, and respiratory measurements and activity using MindWare Mobile Impedance Cardiograph. | single time point | |
Secondary | Allostatic Load | An aggregate score derived from measures of urinary cortisol, norepinephrine, epinephrine, blood cholesterol, high sensitivity c-reactive protein, and hemoglobin A1C. | single time point | |
Secondary | Baseline and change in salivary cortisol in response to test meal | Salivary cortisol measured by enzyme-linked immunosorbent assay (ELISA) | 0, immediately post-prandial, 30, 60, and 90 minutes post-prandial | |
Secondary | Baseline and change in salivary cortisol in response to exercise | Salivary cortisol measured by enzyme-linked immunosorbent assay (ELISA) | 0, immediately post-exercise, 30, 60, and 90 minutes post-exercise | |
Secondary | Baseline and change in salivary cortisol in response to emotional recall task | Salivary cortisol measured by enzyme-linked immunosorbent assay (ELISA) | 0, immediately post-task, 30, 60, and 90 minutes post-task | |
Secondary | Baseline and change in breath aldehydes | 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 |
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