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

NCT ID: NCT05488912

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2024-10-10

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.

Detailed Description

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:

• USDA Household Food Sufficiency Questionnaire
• Perceived Nutrition Environment Measurements Survey (NEMS-P)
• Shortened version of the Three Factor Eating Questionnaire
• Latino Dietary Behaviors Questionnaire (LDBQ)
• Global Physical Activity Questionnaire
• Short Acculturation Scale for Hispanics
• NHANES Weight History Questionnaire
• Medical History Questionnaire

Conditions

Food Insecurity; Overweight and Obesity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Two groups of participants will be recruited:

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

2. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New Hampshire Agricultural Experiment Station

UNKNOWN

Sponsor Role: collaborator

University of New Hampshire

OTHER

Sponsor Role: lead

Responsible Party

Maria Carlota Dao

Assistant Professor of Human Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of New Hampshire Health & Wellness

Durham, New Hampshire, United States

Countries

United States

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Other Identifiers

UNH-10-FY2021_49-01

Identifier Type: -

Identifier Source: org_study_id