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Modifying Diet to Improve Gut Microbiome

Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how two lower-calorie diets change gut microbes, the tiny living things in the gut. It is for generally healthy, non-Hispanic Black or white women ages 19–65 with obesity. The study will assign 28 women by chance to a DASH diet, designed to help lower blood pressure, or a standard American diet, with food provided for 4 weeks.

The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female.
  • Non-Hispanic and Black or white.
  • Age 19–65.
  • Body mass index (BMI) of 30 or higher. BMI is a measure of weight compared with height.
  • Able to visit the study's nutrition unit every day.

Who can't join

  • Digestive tract conditions, such as irritable bowel, diverticulitis (inflamed pouches in the gut), stomach ulcers, Crohn's disease, digestive tract cancers, or adenomatous polyps (growths that can turn into cancer).
  • Used antibiotics or probiotics in the past 90 days. Probiotics contain live microbes.
  • Tobacco use.
  • Heavy alcohol use.
  • Major health conditions, such as kidney disease, diabetes, or cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * female * non-Hispanic, black or white * age 19-65 years * BMI \>= 30 kg/m\^2 * able to visit Bionutrition Unit daily Exclusion Criteria: * gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps * antibiotic or probiotic use in the previous 90 days * tobacco use * heavy alcohol consumption * major medical conditions (e.g., renal disease, diabetes, cancer)

Study sites (1)

FL