Mediterranean Diet and the Gut Microbiome

NCT ID: NCT03269032

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2021-01-01

Brief 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

Irritable Bowel Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Phase 1 Healthy Volunteers

Healthy volunteers will eat a typical American diet for 2 weeks and then eat a Mediterranean-style diet for 2 weeks.

Group Type: EXPERIMENTAL

American Diet

Intervention Type: OTHER

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.

Mediterranean-style Diet

Intervention Type: OTHER

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.

Phase 2 IBS Patients

Participants with IBS will eat a typical American diet for 2 weeks and then eat a Mediterranean-style diet for 2 weeks

Group Type: EXPERIMENTAL

American Diet

Intervention Type: OTHER

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.

Mediterranean-style Diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• must be willing to eat pre-prepared foods for 4 weeks
• subjects must have no medical, religious, or cultural dietary restrictions that would preclude their eating a Mediterranean diet.
• Phase 2 subjects- must have diagnosis of IBS based on Rome III criteria and have diarrhea-predominant disease, defined as >50% of bowel movements characterized as diarrhea

Exclusion Criteria

• history of gastrointestinal disease, including celiac disease, inflammatory bowel disease, or lactose intolerance
• diabetes mellitus
• congestive heart failure
• coronary artery disease
• chronic liver disease or end stage renal disease
• pregnancy or breastfeeding
• trainees under the direct supervision of the PI and patients receiving direct ongoing medical care from the PI or Co-I will not be enrolled as subjects in this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard B Weinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Heath

Winston-Salem, North Carolina, United States

Countries

United States

References

Cresci GA, Bawden E. Gut Microbiome: What We Do and Don't Know. Nutr Clin Pract. 2015 Dec;30(6):734-46. doi: 10.1177/0884533615609899. Epub 2015 Oct 8.

Reference Type: BACKGROUND

PMID: 26449893 (View on PubMed)

Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9.

Reference Type: BACKGROUND

PMID: 25199904 (View on PubMed)

Shanahan F, Quigley EM. Manipulation of the microbiota for treatment of IBS and IBD-challenges and controversies. Gastroenterology. 2014 May;146(6):1554-63. doi: 10.1053/j.gastro.2014.01.050. Epub 2014 Jan 28.

Reference Type: BACKGROUND

PMID: 24486051 (View on PubMed)

Del Chierico F, Vernocchi P, Dallapiccola B, Putignani L. Mediterranean diet and health: food effects on gut microbiota and disease control. Int J Mol Sci. 2014 Jul 1;15(7):11678-99. doi: 10.3390/ijms150711678.

Reference Type: BACKGROUND

PMID: 24987952 (View on PubMed)

De Filippis F, Pellegrini N, Vannini L, Jeffery IB, La Storia A, Laghi L, Serrazanetti DI, Di Cagno R, Ferrocino I, Lazzi C, Turroni S, Cocolin L, Brigidi P, Neviani E, Gobbetti M, O'Toole PW, Ercolini D. High-level adherence to a Mediterranean diet beneficially impacts the gut microbiota and associated metabolome. Gut. 2016 Nov;65(11):1812-1821. doi: 10.1136/gutjnl-2015-309957. Epub 2015 Sep 28.

Reference Type: BACKGROUND

PMID: 26416813 (View on PubMed)

Mayer EA, Savidge T, Shulman RJ. Brain-gut microbiome interactions and functional bowel disorders. Gastroenterology. 2014 May;146(6):1500-12. doi: 10.1053/j.gastro.2014.02.037. Epub 2014 Feb 28.

Reference Type: BACKGROUND

PMID: 24583088 (View on PubMed)

De Filippo C, Cavalieri D, Di Paola M, Ramazzotti M, Poullet JB, Massart S, Collini S, Pieraccini G, Lionetti P. Impact of diet in shaping gut microbiota revealed by a comparative study in children from Europe and rural Africa. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14691-6. doi: 10.1073/pnas.1005963107. Epub 2010 Aug 2.

Reference Type: BACKGROUND

PMID: 20679230 (View on PubMed)

Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.

Reference Type: BACKGROUND

PMID: 21885731 (View on PubMed)

Wang Q, Garrity GM, Tiedje JM, Cole JR. Naive Bayesian classifier for rapid assignment of rRNA sequences into the new bacterial taxonomy. Appl Environ Microbiol. 2007 Aug;73(16):5261-7. doi: 10.1128/AEM.00062-07. Epub 2007 Jun 22.

Reference Type: BACKGROUND

PMID: 17586664 (View on PubMed)

Schloss PD, Westcott SL, Ryabin T, Hall JR, Hartmann M, Hollister EB, Lesniewski RA, Oakley BB, Parks DH, Robinson CJ, Sahl JW, Stres B, Thallinger GG, Van Horn DJ, Weber CF. Introducing mothur: open-source, platform-independent, community-supported software for describing and comparing microbial communities. Appl Environ Microbiol. 2009 Dec;75(23):7537-41. doi: 10.1128/AEM.01541-09. Epub 2009 Oct 2.

Reference Type: BACKGROUND

PMID: 19801464 (View on PubMed)

Weinberg RB, Dantzker C, Patton CS. Sensitivity of serum apolipoprotein A-IV levels to changes in dietary fat content. Gastroenterology. 1990 Jan;98(1):17-24. doi: 10.1016/0016-5085(90)91285-e.

Reference Type: BACKGROUND

PMID: 2104541 (View on PubMed)

McCombs RJ, Marcadis DE, Ellis J, Weinberg RB. Attenuated hypercholesterolemic response to a high-cholesterol diet in subjects heterozygous for the apolipoprotein A-IV-2 allele. N Engl J Med. 1994 Sep 15;331(11):706-10. doi: 10.1056/NEJM199409153311104.

Reference Type: BACKGROUND

PMID: 8058077 (View on PubMed)

Mishra SP, Wang B, Jain S, Ding J, Rejeski J, Furdui CM, Kitzman DW, Taraphder S, Brechot C, Kumar A, Yadav H. A mechanism by which gut microbiota elevates permeability and inflammation in obese/diabetic mice and human gut. Gut. 2023 Oct;72(10):1848-1865. doi: 10.1136/gutjnl-2022-327365. Epub 2023 Mar 22.

Reference Type: DERIVED

PMID: 36948576 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00039422

Identifier Type: -

Identifier Source: org_study_id