University of New Hampshire Health & Wellness
Durham, New Hampshire, 03824, United States
NCT Number: NCT05488912
This study will include a group of 60 Hispanic adults living in New Hampshire with or without overweight/obesity. The study aims to assess food access and intake of fiber-rich foods, characterize fecal microbiota composition, and assess the relationship between the intake of fiber-rich foods and components of the gut microbiota-gut-brain axis. These aims will be accomplished through biospecimen collection including a pre-collected stool sample, a fasting blood sample, and a Mixed Meal Tolerance Test (MMTT). In addition, participants will answer questionnaires on dietary intake, food insecurity and access, physical activity, eating behavior, and sociodemographic characteristics.
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Notify Me18 year–55 year
All sexes
Observational
Durham, New Hampshire, 03824, United States
This study will include Hispanic adults living in New Hampshire with or without overweight/obesity. In a group of 60 participants, the study aims to assess food access and intake of fiber-rich foods, characterize fecal microbiota composition, and assess the relationship between the intake of fiber-rich foods and components of the gut microbiota-gut-brain axis.
The study involves biospecimen collection including a pre-collected stool sample, a fasting blood sample, and a Mixed Meal Tolerance Test (MMTT). In addition, participants will answer questionnaires on dietary intake, food insecurity and access, physical activity, eating behavior, and sociodemographic characteristics.
Pre-collected stool samples will be obtained from participants. Anthropometric measurements will be collected at the time of the study visit including height, weight, and waist and hip circumference. BMI will be calculated. An intra-venous catheter will be inserted by a healthcare professional to first collect a fasting blood sample, and will remain inserted for all following blood samples. Subjects will then undergo a Mixed Meal Tolerance Test (MMTT), a validated metabolic assessment in which the participant ingests a liquid mixed meal (e.g., Boost or Ensure), and blood samples are subsequently collected 15min, 30min, 60min and 120min after meal ingestion.
In the intervals between blood sample collections, subjects will complete questionnaires on dietary intake, food insecurity and access, physical activity, eating behavior, and sociodemographic characteristics. The following validated measures will be used to assess these aims:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: August 2022 to August 2023
Food insecurity scores will be generated at the household and individual level. Objective measures of food environment and access will be calculated using a modified version of the Retail Food environment Index (RFEI) that focuses on government assistance food sources within a radius around individuals' residential address (e.g., pantries, stores selling fresh food, SNAP retailers). Perceived food environment and access scores will be obtained from the NEMS-P. This questionnaire includes questions about food purchasing habits, priorities for food purchasing choices, characteristics of the local food environment including food availability at retailers and vendors, and food availability at home.
Time frame: August 2022 to August 2023
Fiber intake will be calculated using validated analytical pipelines of the NHANES DSQ, developed at the National Cancer Institute. This methodology will be used to calculate predicted daily intakes of total fiber. The PI has previously used this methodology with Hispanic older adults. A comprehensive list of specific fiber-rich foods routinely consumed will be compiled, which will enable the identification of opportunities to increase local fiber-rich food production and consumption by highlighting foods commonly consumed by NH Hispanics (or gaps in current diets that could be fulfilled with local foods).
Time frame: August 2022 to August 2023
Microbial richness (number of different taxonomic groups per sample) will be established using Dirichlet multinomial mixtures. Relative abundance of bacterial groups (e.g., at the species, genus, phylum level) will also be calculated.
Time frame: August 2022 to August 2023
The SCFA assessment will focus on total SCFA, butyrate, acetate, and propionate. SCFA analysis will be measured using gas chromatography coupled with flame ionization detection.
Time frame: August 2022 to August 2023
The concentration of lipopolysaccharides (LPS) in the blood, a measure of gut permeability, will be measured. High circulating LPS, known as metabolic endotoxemia, is associated with insulin resistance, obesity, and other metabolic complications.
Time frame: August 2022 to August 2023
Insulin levels will be measured using an enzyme-linked immunoassay (ELISA). The levels will be measured both from a fasting blood sample, and during MMTT. The fasting level will be used to for the calculation of the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Time frame: August 2022 to August 2023
Fasting glucose level will be used to for the calculation of the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Time frame: August 2022 to August 2023
The levels of GLP-1 will be measured using an enzyme-linked immunoassay (ELISA). The levels of this hormone will be measured both from a fasting blood sample, and during MMTT.
Time frame: August 2022 to August 2023
The levels of ghrelin will be measured using an enzyme-linked immunoassay (ELISA). The levels of this hormone will be measured both from a fasting blood sample, and during MMTT.
Time frame: August 2022 to August 2023
Fruit, vegetable, and whole grain intake will be calculated using validated analytical pipelines of the NHANES DSQ, developed at the National Cancer Institute. These methodologies will be used to calculate predicted daily intakes of servings of fruits, vegetables, vegetables including legumes, and whole grains.
Time frame: August 2022 to August 2023
Individual enterotype classification of gut microbiota, a measure of the dominant taxonomic groups per individual, will be established using Dirichlet multinomial mixtures.
University of New Hampshire
Other
Fiber-rich Foods, Weight Status, and the Gut Microbiota: A Comparative Study in NH Hispanic Adults at Risk for Food Insecurity
Acronym: FIRST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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