Modifying Diet to Improve Gut Microbiome

NCT ID: NCT03924778

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DASH diet

calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber

Group Type EXPERIMENTAL

DASH diet

Intervention Type BEHAVIORAL

brief description

standard American diet

calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber

Group Type ACTIVE_COMPARATOR

standard American diet

Intervention Type BEHAVIORAL

describe

Interventions

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DASH diet

brief description

Intervention Type BEHAVIORAL

standard American diet

describe

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiffany L Carson, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffit Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Tiffany L Carson, PhD

Role: CONTACT

813-745-4944

Facility Contacts

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Tiffany Carson, PhD

Role: primary

813-745-4944

Other Identifiers

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IRB-300003207

Identifier Type: -

Identifier Source: org_study_id

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