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Mediterranean Diet and the Gut Microbiome

NCT03269032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-22

No results posted yet for this study

Summary

This study will evaluate the impact of a Mediterranean-style diet on microbiome diversity compared to a typical American diet. The study will observe the microbiome composition comparisons in healthy volunteers as well as in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) to see if the consumption of a Mediterranean-style diet has a positive effect on improving symptoms of IBS-D.

Conditions

  • Irritable Bowel Syndrome

Interventions

OTHER

American Diet

According to National Health and Nutritional Examination Survey (NHANES) data, the nutritional composition of the baseline typical American diet is 50%Carbohydrates, 15% Protein, 35% Fat, \>11% Saturated Fatty Acids, \<12% Monounsaturated Fatty Acids, and \>8% Polyunsaturated Fatty Acids. Participants will receive 3 meals and 1 snack for each day during the study period.

OTHER

Mediterranean-style Diet

The nutritional composition of the baseline typical Mediterranean-style diet is 46% Carbohydrates/Alcohol (red wine will be included in the Mediterranean diet only), 17% Protein, 32% Fat, \<7% Saturated Fatty Acids, \>18% Monounsaturated Fatty Acids and \<5% Polyunsaturated Fatty Acids. Participants will receive 3 meals and 1 snack for each day during the study period.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Richard B Weinberg, MD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03269032 on ClinicalTrials.gov