Investigating whether a person's genes or sex affects the range of microbes in their gut when they eat a Mediterranean or Western diet

Not Applicable

Completed

• Conditions: Gut microbiome in people following two dietary patterns; Digestive System

• Registration Number: ISRCTN73075133
• Lead Sponsor: Fisabio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-02
• Study Completion: 2022-02-15
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Aged 18-75 years with 50% females
2. Has a dietary profile (Mediterranean diet or Western diet)

Exclusion Criteria

1. Received antibiotics or prebiotics or probiotics in the last 6 months
2. Diseased
3. Immunodeficient or HIV-positive
4. Liver cirrhosis or chronic renal failure
5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc
6. Any severe co-morbid condition
7. Alcohol abuse or addiction
8. History of major organ transplantation
9. Concurrent therapy with immunosuppressive drugs or cytotoxic agents
10. Current treatment with systemic corticosteroids
11. Current use of weight loss medication
12. Patients with an acute infection or inflammation
13. Pregnant or breastfeeding women
14. Any other condition that may interfere with the completion of the study protocol

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 03/01/2023:<br> 1. Composition of bacteria and fungi in stool samples assessed using DNA sequencing at baseline and 6 months<br> 2. Metabolic functions of the microbiota assessed using bioinformatic tools at baseline and 6 months<br> 3. Host genomic profile assessed using a genome-wide genotyping array at baseline<br><br> _____<br><br> Previous primary outcome measures:<br> 1. Composition of bacteria and fungi in stool samples assessed using DNA sequencing at baseline and 8 months<br> 2. Metabolic functions of the microbiota assessed using bioinformatic tools at baseline and 8 months<br> 3. Host genomic profile assessed using a genome-wide genotyping array at baseline<br>