Healthy
Conditions
Brief summary
The project will characterize human gut microbiome response to two different diets and the possible physiological and biochemical implications of such response on cardiometabolic risk factors. The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.
Detailed description
The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.
Interventions
OTHERdiet
dietary patterns
Sponsors
South Dakota State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* generally good health status based on one routine physical in the past 15 months, current health status * normal HbA1C, weigh 110 lb or more * Age 50 years or more, generally healthy, all races and both sexes * generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and * willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
Exclusion criteria
* medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use * Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight. * impaired kidney functions * Active history of cancer, diabetes, heart, liver, and kidney diseases * major gastrointestinal disorders in the past 3 months * history of heart attacks or stroke * Unable to meet in-person visit requirements for dining, picking up meals, and tests * Any mental health condition that would affect the ability to provide written informed consent. * If they had not had a routine health checkup during the 12 months prior to recruitment. * If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota-dependent TMAO-response, measured as serum concentration | 10 days per diet arm | targeted sequencing |
| Serum concentration of biogenic amine metabolites | 10 days per diet arm | Metabolomics |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMoul Dey, Ph.D
South Dakota State University
Outcome results
None listed