NCT05488912Completed
Fiber-rich Foods, Weight Status, and the Gut Microbiota in NH Hispanic Adults at Risk for Food Insecurity
Fiber-rich Foods, Weight Status, and the Gut Microbiota: A Comparative Study in NH Hispanic Adults at Risk for Food Insecurity
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 61 (actual)
- First submitted
- 26 Jul 2022
- Start date
- 28 Mar 2022
- Primary completion date
- 10 Oct 2024
- Lead sponsor
- University of New Hampshire
- Diseases
- Obesity
- NCT number
- NCT05488912
What you commit to
- Study type: Observational
- Participants enrolled: 61
- From 28 Mar 2022 to the primary completion date, 10 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- Two groups of participants will be recruited:
- Healthy BMI (20-25 kg/m2, n=30), and
- Overweight/Obese BMI (\>28 kg/m2, n=30)
- Other inclusion criteria are as follows:
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Hampshire Health & Wellness Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.