Fiber-rich Foods, Weight Status, and the Gut Microbiota in NH Hispanic Adults at Risk for Food Insecurity

NCT05488912 | Completed

• 1 other identifier: UNH-10-FY2021_49-01
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Insecurity; Overweight and Obesity

Keywords

Overweight; Obesity; Food insecurity; Hispanic/Latino; Gut microbiome

Outcome Measures

Primary Outcomes (9)

• Food Insecurity and Access

  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.

  August 2022 to August 2023

• Fiber Intake

  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).

  August 2022 to August 2023

• Microbial Richness

  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.

  August 2022 to August 2023

• Short-Chain Fatty Acids

  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.

  August 2022 to August 2023

• LPS

  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.

  August 2022 to August 2023

• Insulin

  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).

  August 2022 to August 2023

• Glucose

  Fasting glucose level will be used to for the calculation of the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).

  August 2022 to August 2023

• GLP-1

  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.

  August 2022 to August 2023

• Ghrelin

  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.

  August 2022 to August 2023

Secondary Outcomes (2)

• Fruit, Vegetable, and Whole Grain Intake

  August 2022 to August 2023

• Enterotype Classification of Gut Microbiota

  August 2022 to August 2023

Study Arms (2)

Healthy BMI (20-25 kg/m2, n=30)

A group of 30 Hispanic/Latino adults who are NH residents residing in SNAP-eligible households, and have a BMI between 20 and 25 kg/m2.

Overweight/Obese BMI (>28 kg/m2, n=30)

A group of 30 Hispanic/Latino adults who are NH residents residing in SNAP-eligible households, and have a BMI greater than or equal to 28 kg/m2.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of two groups of participants, one group which is composed of participants with a healthy BMI and the other which is composed of overweight/obese participants. All participants will have self-identified as having an origin or cultural background in a Spanish-speaking country and be between the ages of 18 and 55. All participants will come from SNAP-eligible households. For this study, a SNAP-eligible household is one where the household income is 150% of the national poverty level.

You may qualify if:

• Two groups of participants will be recruited:
• Healthy BMI (20-25 kg/m2, n=30), and
• Overweight/Obese BMI (\>28 kg/m2, n=30)
• Adult men and women (18-55 years of age) residing in a SNAP-eligible households;
• Self-identifying as Hispanic or Latino, and with origin or cultural background from a Spanish-speaking Latin American country;
• Willingness and ability to provide a signed informed consent; and
• Willingness to complete study visits and participate in all aspects of the study.

You may not qualify if:

• Adults reporting any of the following conditions will be excluded from the study:
• Diagnosed type 2 diabetes, chronic kidney or liver disease, cancer, chronic gastrointestinal conditions, cognitive impairment or incapacitating mental health problems, lack of mobility and physical independence, self-reported weight loss \>5 kg within past 6 months, history of communicable or chronic diseases, medication use or surgery that would preclude safe and active study participation, bariatric surgery, antibiotic use within past 3 months, ongoing participation in other clinical trials, use of anti-obesity medications within the past year, inability to communicate in oral and written form in English and/or Spanish, and habitual consumption of more than two alcoholic drinks per day or of illegal drugs.

Sponsors & Collaborators

• University of New Hampshire: lead
• New Hampshire Agricultural Experiment Station: collaborator

Study Sites (1)

University of New Hampshire Health & Wellness

Durham, New Hampshire, 03824, United States

Location

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Both fasting blood samples and blood samples collected during a mixed-meal tolerance test will be collected and used for glucose and hormone assessment. Pre-collected stool samples will be obtained from participants for SCFA assessment.

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Human Nutrition

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 5, 2022
• Study Start: March 28, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)