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NCT Number: NCT03924778

Modifying Diet to Improve Gut Microbiome

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moffit Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DASH diet

Behavioral

brief description

standard American diet

Behavioral

describe

Primary outcomes

  1. Mean Weight Change of Participants

    Time frame: Baseline to day 28

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

  2. Mean Weight Change of Participants

    Time frame: Day 28 to Day 42

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

  3. Mean Weight Change of Participants

    Time frame: Baseline to day 42

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

  4. Diet-specific changes in secondary bile acid

    Time frame: Baseline to day 28

    The investigators will calculate changes in cholic acid in milligrams.

  5. Diet-specific changes in secondary bile acid

    Time frame: day 28 to day 42

    The investigators will calculate changes in cholic acid in milligrams.

  6. Diet-specific changes in secondary bile acid

    Time frame: baseline to day 42

    The investigators will calculate changes in cholic acid in milligrams.

  7. Diet-specific changes in inflammatory marker

    Time frame: baseline to day 28

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

  8. Diet-specific changes in inflammatory marker

    Time frame: day 28 to day 42

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

  9. Diet-specific changes in inflammatory marker

    Time frame: baseline to day 42

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

  10. Diet-specific changes in short chain fatty acids

    Time frame: baseline to day 28

    The investigators will calculate changes in acetic acid in mmol/L

  11. Diet-specific changes in short chain fatty acids

    Time frame: day 28 to day 42

    The investigators will calculate changes in acetic acid in mmol/L

  12. Diet-specific changes in short chain fatty acids

    Time frame: baseline to day 42

    The investigators will calculate changes in acetic acid in mmol/L

Interested in participating?

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Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2019
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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