Inflammatory and metabolic effect of food change between traditional and western-type foods in healthy male individuals Nutritional, Metabolic, Endocrine
Conditions
Interventions
This dietary intervention will focus on the effect of food change between traditional Tanzanian and western-type foods on inflammatory, metabolic changes and changes in the gut microbiome composition.
Sponsors
Radboud University Nijmegen Medical Centre
Kilimanjaro Clinical Research Institute (KCRI)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Tanzanian healthy male individuals aged 20-40 years and BMI 18-25 kg/m² 2. Living either in rural or in urban areas in the Moshi district for more than a month before participation and consuming either a traditional Tanzanian or a western-type diet 3. Use alcohol, either local brew ‘Mbege’ or commercially available beer 4. Can stay in the study area throughout the intervention period Justification: Age, gender, and BMI are known to influence immune responses including inflammation, and they also affect the composition of gut microbiota. Elderly individuals have declined immune function, a phenomenon referred to as immunosenescence, while higher BMI is associated with increased inflammation. On the other hand, females have varying hormonal levels linked to the menstrual cycle and the use of contraceptives. The choice of age categories, BMI range, and sex are done to limit the well know confounding effects of these factors on inflammation and on gut microbiota composition among individuals.
Exclusion criteria
Exclusion criteria: 1. HIV seropositive 2. Malaria seropositive - updated 29/03/2021: positive malaria rapid diagnostic test 3. Blood pressure outside the defined range (=60 mmHg diastolic or =140 mmHg systolic) 4. Fasting blood sugar (>6.0 mmol/l) 5. BMI outside the defined range (18-25 kg/m²) 6. Food allergies 7. Acute (febrile) illness in the previous month 8. Use of any medication as well as the use of antibiotics in the past three months or vaccination 9. hospital admission in the past year 10. A known chronic condition such as active malignancy, liver or kidney disease, tuberculosis infection, chronic hepatitis B or C infection 11. History of hypertension, diabetes, cardiovascular diseases 12. Failure to consent 13. Female sex 14. None alcohol users or reported alcoholism 15. Participation in another clinical trial at the same time or within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 29/03/2021: 1. Circulating inflammation-related human protein biomarkers measured using enzyme-linked immunosorbent assay (ELISA) or comparable techniques at baseline (day 0), post intervention (day 14) and 30 days post intervention (day 44) 2. The capacity of the circulating immune cells to produce inflammatory cytokines in ex vivo whole blood stimulation to different stimuli, measured using ELISA on the culture supernatant at baseline (day 0), post intervention (day 14) and 30 days post intervention (day 44) 3. Blood transcriptome measured using RNAseq technology with NovaSeq™ Sequencing System at baseline (day 0), post intervention (day 14) and 30 days post intervention (day 44) 4. Plasma metabolome assessed using high-throughput mass spectrometry (untargeted metabolomics) at baseline (day 0), post intervention (day 14) and optionally at day 30 post intervention (day 44) 5. Coagulation parameters (thrombin and plasmin generation) measured using modified calibrated automated thrombography (MidiCAT; Synapse Research Institute, Maastricht, the Netherlands) at baseline (day 0), post intervention (day 14) and 30 days post intervention (day 44) 6. Gut microbiome composition measured using metagenomic sequencing of stool samples collected at baseline (day 0), post intervention (day 14) and optionally at 30 days post intervention (day 44) Previous primary outcome measures: Measured at baseline and after 2 weeks of the dietary intervention: 1. Circulating inflammation-related human protein biomarkers measured using enzyme-linked immunosorbent assay (ELISA) or comparable techniques at baseline (day 0), post intervention (day 14) and 30 days post intervention (day 44) 2. The capacity of the circulating immune cells to produce inflammatory cytokines in ex vivo whole blood stimulation to different stimuli, measured using ELISA on the culture supernatant at baseline (day 0), post intervention (day 14) and 30 days post intervention (day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 29/03/2021: Plasma lipids (lipidome) measured using mass spectrometry analysis (LC-MS) at baseline (day 0), post intervention (day 14) and 30 days post intervention (day 44) Previous secondary outcome measure: Gut microbiome composition measured using metagenomic sequencing of stool samples collected at baseline (day 0), post intervention (day 14) and 30 days post intervention (day 44). | — |
Countries
Tanzania
Contacts
Public ContactGodfrey;Vesla Temba;Kullaya
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Outcome results
None listed