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Trials / Completed

CompletedNCT03269032

Mediterranean Diet and the Gut Microbiome

Impact of the Mediterranean Diet on the Gut Microbiome and Symptoms of Diarrhea-Predominant Irritable Bowel Syndrome

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed description

Irritable bowel syndrome (IBS) is the most prevalent and well-studied functional gastrointestinal disorder. While IBS has no direct mortality, it does compromise quality of life, incurs morbidity, and has a substantial economic impact on society. The gut microbiome may play a significant role in the pathogenesis of IBS. Even though the exact mechanisms underlying this relationship have not been presented, it is suggested that certain microorganisms may increase gut permeability, activate the mucosal immune response, increase visceral sensitivity and alter intestinal motility via a bidirectional brain-gut interaction. Recent studies suggest that the salutary impact of the Mediterranean diet may be due to its effects on the composition of the gut microbiome. In a recent cohort study in Italy, subjects who adhered most closely to a classical Mediterranean diet had more favorable bacterial enterotypes (e.g., Prevotella) in their stool, as well as higher levels of short-chain fatty acids - which are essential for colonic function. Studies have also showed that diet alters the predominant microbiome enterotypes and that microbiome composition can change quickly, within 24 hours, after a dietary intervention. Therefore, consumption of a Mediterranean diet may ameliorate the gut dysbiosis associated with IBS-D.

Conditions

Interventions

TypeNameDescription
OTHERAmerican DietAccording 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.
OTHERMediterranean-style DietThe 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.

Timeline

Start date
2017-10-10
Primary completion
2021-01-01
Completion
2021-01-01
First posted
2017-08-31
Last updated
2023-03-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03269032. Inclusion in this directory is not an endorsement.