The effect of food change between traditional Tanzanian and western-type foods on inflammation and metabolism
- Conditions
- Inflammatory and metabolic effect of food change between traditional and western-type foods in healthy male individualsNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN15619939
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 76
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method