Clinical trial

Modifying Diet to Improve Gut Microbiome

Opening soon · Not applicable · 1 countries · Registry ID NCT03924778

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersAccepted

ConditionObesity

Full registry 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)

Treatments and study arms

DASH diet

Behavioral

brief description

standard American diet

Behavioral

describe

Primary outcomes

Mean Weight Change of ParticipantsBaseline to day 28

Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.

Mean Weight Change of ParticipantsDay 28 to Day 42

Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.

Mean Weight Change of ParticipantsBaseline to day 42

Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.

Diet-specific changes in secondary bile acidBaseline to day 28

The investigators will calculate changes in cholic acid in milligrams.

Diet-specific changes in secondary bile acidday 28 to day 42

The investigators will calculate changes in cholic acid in milligrams.

Diet-specific changes in secondary bile acidbaseline to day 42

The investigators will calculate changes in cholic acid in milligrams.

Diet-specific changes in inflammatory markerbaseline to day 28

The investigators will calculate changes in c-reactive protein in mg/L.

Diet-specific changes in inflammatory markerday 28 to day 42

The investigators will calculate changes in c-reactive protein in mg/L.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Moffit Cancer Center🇺🇸 Tampa, Florida, United States

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Tiffany Carson, PhDContact

Email · Call 813-745-4944

Tiffany Carson, PhDPrincipal Investigator