Mediterranean Diet and the Gut Microbiome

NCT03269032 | Completed

• 1 other identifier: IRB00039422
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Mediterranean diet; gut microbiome; gastrointestinal

Outcome Measures

Primary Outcomes (2)

• Phase 1- Change in predominant enterotypes and diversity of fecal microbiota

  Fecal microbiota diversity and enterotypes will be determined through bacterial 16S rRNA gene sequences on stool samples collected from the healthy volunteer participants in phase 1.The data will initially be analyzed by calculating descriptive statistics and plotting to examine for potential outliers and the necessity for data transformation.

  Baseline, 2 weeks, 4 weeks

• Phase 2-Change in predominant enterotypes and diversity of fecal microbiota

  Fecal microbiota diversity and enterotypes will be determined through bacterial 16S rRNA gene sequences on stool samples and rectal biopsies performed on the subjects with IBS-D in phase 2.The data will initially be analyzed by calculating descriptive statistics and plotting to examine for potential outliers and the necessity for data transformation.

  Baseline, 2 weeks, 4 weeks

Secondary Outcomes (4)

• Changes in plasma inflammatory marker - Erythrocyte sedimentation rate (ESR)

  Baseline, 2 weeks, 4 weeks

• Changes in plasma inflammatory marker - C-reactive protein (CPR)

  Baseline, 2 weeks, 4 weeks

• Changes in IBS Symptom Severity Scores

  Baseline, 2 weeks, 4 weeks

• Changes in Hospital Anxiety and Depression Scores

  Baseline, 2 weeks, 4 weeks

Study Arms (2)

Phase 1 Healthy Volunteers

EXPERIMENTAL

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

Other: American Diet; Other: Mediterranean-style Diet

Phase 2 IBS Patients

EXPERIMENTAL

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

Other: American Diet; Other: Mediterranean-style Diet

Interventions

American Diet 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.

Phase 1 Healthy Volunteers; Phase 2 IBS Patients

Mediterranean-style Diet 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 1 Healthy Volunteers; Phase 2 IBS Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Heath

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (13)

• 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.

  PMID: 26449893 BACKGROUND

• 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.

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• 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.

  PMID: 24486051 BACKGROUND

• 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.

  PMID: 24987952 BACKGROUND

• 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.

  PMID: 26416813 BACKGROUND

• 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.

  PMID: 24583088 BACKGROUND

• 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.

  PMID: 20679230 BACKGROUND

• 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.

  PMID: 21885731 BACKGROUND

• 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.

  PMID: 17586664 BACKGROUND

• 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.

  PMID: 19801464 BACKGROUND

• 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.

  PMID: 2104541 BACKGROUND

• 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.

  PMID: 8058077 BACKGROUND

• 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.

  PMID: 36948576 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Richard B Weinberg, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will have two phases, Phase 1 will study healthy subjects, who will follow a typical American diet for 2 weeks, and then cross-over to a Mediterranean-style diet for 2 weeks. Phase 2 will study subjects who have IBS-D. As above, they will first eat a typical American diet for 2 weeks, and then cross-over to a Mediterranean-style diet.

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: August 31, 2017
• Study Start: October 10, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 22, 2023

Record last verified: 2021-10

Locations

US (1)