Gut microbiome in people following two dietary patterns Digestive System
Conditions
Interventions
A longitudinal study will be carried out. Samples and data will be obtained at baseline and after 8 months of follow-up. Two groups of diets will be compared in an observational design. Mendelian rand
Sponsors
Fisabio
University of Valencia
CIBEROBN
Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years with 50% females 2. Has a dietary profile (Mediterranean diet or Western diet)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 03/01/2023: 1. Composition of bacteria and fungi in stool samples assessed using DNA sequencing at baseline and 6 months 2. Metabolic functions of the microbiota assessed using bioinformatic tools at baseline and 6 months 3. Host genomic profile assessed using a genome-wide genotyping array at baseline _____ Previous primary outcome measures: 1. Composition of bacteria and fungi in stool samples assessed using DNA sequencing at baseline and 8 months 2. Metabolic functions of the microbiota assessed using bioinformatic tools at baseline and 8 months 3. Host genomic profile assessed using a genome-wide genotyping array at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 03/01/2023: 1. Host genome-wide determinations assessed by microarray at baseline 2. Blood pressure measured using standard methods at baseline and longitudinally at 6 months 3. Weight measured using validated scales and bioimpedance at baseline and 6 months 4. Height measured using standard methods at baseline and 6 months 5. Waist circumference measured using standard methods at baseline and 6 months 6. Body composition measured by bioimpedance at baseline and 6 months 7. Food intake and adherence to the Mediterranean diet will be measured using the 14-item Mediterranean diet adherence PREDIMED score at baseline and 6 months 8. Dietary intake assessed using dietary questionnaires (24-h recalls and food frequency questionnaires) at baseline and 6 months 9. Physical activity measured using the short form of the Minnesota physical activity questionnaire at baseline and 6 months 10. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire at baseline and after 6 months 11. Chronotype (i.e. morning or evening person) measured using the Horne and Östberg questionnaire at baseline 12. Cognitive function measured using the TMT-A, TMT-B, COWAT and Wechsler Adult Intelligence Scale-III tests at baseline and after 6 months 13. Plasma lipids measured using standard methods at baseline and after 6 months 14. Fasting glucose measured using colorimetric methods at baseline and after 6 months 15. Bilirubin measured using colorimetric methods at baseline and after 6 months 16. Blood counts measured using standard methods at baseline and after 6 months _____ Previous secondary outcome measures: 1. Host genome-wide d | — |
Countries
Spain
Outcome results
None listed