Healthy Adult Females, Healthy Adult Males
Conditions
Keywords
whole grain corn
Brief summary
The purpose of this research study is to identify biomarkers of whole grain (WG) corn intake following an acute exposure in a pharmacokinetic (how the body absorbs, processes, and gets rid of a substance or ingredient) feeding study. In this aim, investigators will conduct a randomized crossover acute pharmacokinetic study of corn. Investigators will then use a targeted metabolomics approach to identify the exposure markers of corn intake, further develop analytical methods to study its pharmacokinetics, and build our in-house WG metabolite database and an untargeted metabolomics approach to investigate postprandial biomarkers of corn intake. At the completion of this study, our expectation is that investigators will identify corn phytochemicals and its metabolites as objective biomarkers of total and individual WG corn that are commonly consumed by Americans.
Detailed description
Days 0-7: Healthy volunteers were recruited and instructed to avoid consuming any whole-grain products beginning one week before the intervention and continuing throughout the study period. Day 8 - Pharmacokinetic (PK) Visit 1: Participants consumed two servings of either whole-grain or refined-grain (46 g of raw grain per serving; 92 g total). Blood and urine samples were collected at multiple time points over 48 hours, and baseline fecal samples were collected the day before the intervention. Day 15 - Pharmacokinetic (PK) Visit 2: After a 6-day washout period, participants crossed over to the alternate treatment. Blood and urine samples were again collected at multiple time points over 48 hours.
Interventions
DIETARY_SUPPLEMENTWhole-Grain Corn
Participants will consume two servings of cooked whole-grain corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
DIETARY_SUPPLEMENTRefined Corn
Participants will consume two servings of cooked refined corn (46 g raw grain per serving; 92 g total) during the pharmacokinetic study visit.
Sponsors
North Carolina Agriculture & Technical State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 25-70 years * Body mass index (BMI) between 18 and 30 kg/m² * Able to read, speak, and understand English * No known allergy or intolerance to the test foods * Normal blood and urine biochemical parameters * No antibiotic use within the past 6 months * Willing and able to comply with all study procedures, including dietary restrictions throughout the study period * No medical conditions or lifestyle factors that, in the opinion of the investigators, would interfere with the study objectives
Exclusion criteria
* Active disease, including gout, heart disease, peripheral vascular disease, kidney disease, liver disease, cancer, diabetes, gastrointestinal disorders, or endocrine disorders that may interfere with the study * Current smoker or use of tobacco products * Unwilling or unable to comply with the required dietary restrictions during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma and Urine Metabolite Concentration Following Whole-Grain Product Intake | Baseline through 48 hours after consumption of whole-grain product during pharmacokinetic study visit. | Metabolite concentration will be measured at baseline and at postprandial time points following consumption of the whole-grain products using untargeted and targeted metabolomics. Changes from baseline in metabolite concentrations will be reported to characterize the acute metabolic response to whole-grain products. |
Countries
United States
Contacts
CONTACTShengmin Sang
Outcome results
None listed