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Food InsecurityFIRSTNCT05488912

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

An observational study of Food Insecurity and Overweight and Obesity, run by University of New Hampshire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Food Insecurity, Overweight and Obesity
How many people
61 participants
Where
1 siteUnited States
Study dates
28 Mar 2022to 10 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of New Hampshire Health & Wellness

    Durham, New Hampshire, 03824

Other trials in United States

About this study

Official title: Fiber-rich Foods, Weight Status, and the Gut Microbiota: A Comparative Study in NH Hispanic Adults at Risk for Food Insecurity

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.

Read the 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
Keywords
Overweight, Obesity, Food insecurity, Hispanic/Latino, Gut microbiome
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05488912
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: August 2022 to August 2023

  2. 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).

    Measured: August 2022 to August 2023

  3. 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.

    Measured: August 2022 to August 2023

  4. 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.

    Measured: August 2022 to August 2023

  5. 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.

    Measured: August 2022 to August 2023

  6. 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).

    Measured: August 2022 to August 2023

  7. Glucose

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

    Measured: August 2022 to August 2023

  8. 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.

    Measured: August 2022 to August 2023

  9. 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.

    Measured: August 2022 to August 2023

Secondary outcomes (2)

  1. Fruit, Vegetable, and Whole Grain Intake

    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.

    Measured: August 2022 to August 2023

  2. Enterotype Classification of Gut Microbiota

    Individual enterotype classification of gut microbiota, a measure of the dominant taxonomic groups per individual, will be established using Dirichlet multinomial mixtures.

    Measured: August 2022 to August 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start28 Mar 2022
  3. Primary completion10 Oct 2024
  4. Study completion10 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05488912
Sponsor's protocol ID
UNH-10-FY2021_49-01
Acronym
FIRST
Status last verified
Mar 2025
First submitted
26 Jul 2022
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared with other researchers. Final data and results will be published and disseminated.

Publications

  • New Hampshire Department of Health and Human Services. Do I Qualify? NHEasy Gateway to Services https://nheasy.nh.gov/#/screening.

  • Besser RE, Jones AG, McDonald TJ, Shields BM, Knight BA, Hattersley AT. The impact of insulin administration during the mixed meal tolerance test. Diabet Med. 2012 Oct;29(10):1279-84. doi: 10.1111/j.1464-5491.2012.03649.x.

    PubMed 22435709

  • NCCIH Clinical Research Toolbox. https://www.nccih.nih.gov/grants/toolbox (2020).

  • 2020 Census Questionnaire. https://www.census.gov/programs-surveys/decennial-census/technical-documentation/questionnaires/2020.html (2020).

  • Jauregui-Lobera I, Garcia-Cruz P, Carbonero-Carreno R, Magallares A, Ruiz-Prieto I. Psychometric properties of Spanish version of the Three-Factor Eating Questionnaire-R18 (Tfeq-Sp) and its relationship with some eating- and body image-related variables. Nutrients. 2014 Dec 4;6(12):5619-35. doi: 10.3390/nu6125619.

    PubMed 25486370

  • Fernandez S, Olendzki B, Rosal MC. A dietary behaviors measure for use with low-income, Spanish-speaking Caribbean Latinos with type 2 diabetes: the Latino Dietary Behaviors Questionnaire. J Am Diet Assoc. 2011 Apr;111(4):589-99. doi: 10.1016/j.jada.2011.01.015.

    PubMed 21443994

  • Arredondo EM, Sotres-Alvarez D, Stoutenberg M, Davis SM, Crespo NC, Carnethon MR, Castaneda SF, Isasi CR, Espinoza RA, Daviglus ML, Perez LG, Evenson KR. Physical Activity Levels in U.S. Latino/Hispanic Adults: Results From the Hispanic Community Health Study/Study of Latinos. Am J Prev Med. 2016 Apr;50(4):500-508. doi: 10.1016/j.amepre.2015.08.029. Epub 2015 Nov 18.

    PubMed 26597505

  • Marin, G., Sabogal, F., Marin, B. V., Otero-Sabogal, R. & Perez-Stable, E. J. Development of a Short Acculturation Scale for Hispanics. Hispanic Journal of Behavioral Sciences 9, 183-205 (1987).

  • NHANES 2017-2018 Questionnaire Instruments. https://wwwn.cdc.gov/nchs/nhanes/continuousnhanes/questionnaires.aspx?BeginYear=2017.

  • Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.

    PubMed 3123181

  • Vandeputte D, Falony G, Vieira-Silva S, Tito RY, Joossens M, Raes J. Stool consistency is strongly associated with gut microbiota richness and composition, enterotypes and bacterial growth rates. Gut. 2016 Jan;65(1):57-62. doi: 10.1136/gutjnl-2015-309618. Epub 2015 Jun 11.

    PubMed 26069274

  • Harrison GG, Stormer A, Herman DR, Winham DM. Development of a spanish-language version of the U.S. household food security survey module. J Nutr. 2003 Apr;133(4):1192-7. doi: 10.1093/jn/133.4.1192.

    PubMed 12672942

  • Green SH, Glanz K. Development of the Perceived Nutrition Environment Measures Survey. Am J Prev Med. 2015 Jul;49(1):50-61. doi: 10.1016/j.amepre.2015.02.004.

    PubMed 26094227

  • New Hampshire Food Access Map. https://unhcoopext.maps.arcgis.com/apps/MapSeries/index.html?appid=5caa235e0e024beb8bebba50a0297d15&entry=2.

  • Babey, S. H., Diamant, A., Hastert, T. A., Goldstein, H. & Al., E. Designed for Disease: The Link Between Local Food Environments and Obesity and Diabetes. (2008).

Questions about this trial

What is this clinical trial studying?

An observational study of Food Insecurity and Overweight and Obesity, run by University of New Hampshire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Food Insecurity and Access (time frame: August 2022 to August 2023). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05488912, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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