Immune dysregulation and improvement of vaccine responses in overweight/obese adults Other
Conditions
Interventions
Participants will be randomized into one of three intervention arms
1. Traditional plant-based, high fiber and polyphenol diet
2. Traditional fermented banana beverage
3. No treatment (control group).
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/02/2024: 1. Age between 30 and 60 years· 2. BMI > 25 kg/m² at screening (‘overweight/obesity group) or 18.5–24.9 kg/m² at screening (‘normal weight controls) 3. Westernized-style diet as a regular diet, as assessed one week prior to recruitment while participants were taking their usual diets (using a 24-hour dietary recall on three non-consecutive days, including one weekend)· 4. Taking alcoholic drinks but not fermented banana beverage (Consuming a fermented banana beverage less than twice a week). 5. For female: practising highly effective birth control method: this means one of the two: 5.1. Currently using hormonal contraceptive, or 5.2. Providing a consent to oblige to a “double-barrier method” (i.e. 1 physical barrier method plus the use of a chemical barrier, for example, male condom plus spermicide, Types of barrier methods include condoms, diaphragms, cervical caps, and the contraceptive sponge) to prevent conception during the time of the study. Previous inclusion criteria: 1. Age between 35 and 60 years· 2. BMI > 27 kg/m² at screening (‘overweight/obesity group) or 18.5–24.9 kg/m² at screening (‘normal weight controls) 3. Westernized-style diet as a regular diet, as assessed one week prior to recruitment while participants were taking their usual diets (using a 24-hour dietary recall on three non-consecutive days, including one weekend)· 4. Taking alcoholic drinks but not fermented banana beverage (Consuming a fermented banana beverage less than twice a week). 5. For female: practising highly effective birth control method: this means one of the two: 5.1. Currently using hormonal contraceptive, or 5.2. Providing a consent to oblige to a “double-barrier method” (i.e. 1 physical barrier method plus the use of a chemical barrier, for example, male condom plus spermicide, Types of barrier methods include condoms, diaphragms, cervical caps, and the contraceptive sponge) to prevent conception during the time of the study.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as 27/02/2024: 1. A Positive HIV test. 2. A Positive malaria test. 3. A Positive urinary pregnancy test. 4. Abnormal blood pressure (Systolic 140 mmHg, Diastolic 100 mmHg). 5. Diabetic patients (RBG > 11.1 mmol/L). 6. History of fever at least 30 days prior to enrolment. 7. Past medical history of a chronic illness. 8. History of antibiotic therapy or any immune modulatory drugs 3 weeks prior to enrolment. 9. Currently breastfeeding 10. Positive history of mental illness. 11. Positive history of alcohol or illicit drug use. 12. Currently enrolled in a weight loss program or partaking in another clinical trial. Previous exclusion criteria: 1. A Positive HIV test. 2. A Positive malaria test. 3. A Positive urinary pregnancy test. 4. Abnormal blood pressure (Systolic 140 mmHg, Diastolic 100 mmHg). 5. Diabetic patients (RBG > 11.1 mmol/L). 6. History of fever at least 30 days prior to enrolment. 7. Past medical history of a chronic illness. 8. History of antibiotic therapy or any immune modulatory drugs 3 weeks prior to enrolment. 9. Currently breastfeeding or in menopause. 10. Positive history of mental illness. 11. Positive history of alcohol or illicit drug use. 12. Currently enrolled in a weight loss program or partaking in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cytokines will be measured using enzyme-linked immunosorbent assays (ELISA) at baseline, 4 and 8 weeks. 2. Antibody responses to Pneumococcal conjugate and tetanus toxoid vaccines will be measured at baseline and 4 weeks after receiving the vaccines. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma proteome will be measured using the OLINK platform at baseline, 4 and 8 weeks. 2. Plasma metabolome will be measured using untargeted mass spectrometry at baseline, 4 and 8 weeks. 3. Whole blood transcriptome will be measured using RNA sequencing at baseline, 4 and 8 weeks. 4. Gut microbiome will be assessed by sequencing of the V3–V4 region of 16S rRNA gene as well as the internal transcribed spacer (ITS) region of stool samples at baseline, 4 and 8 weeks. 5. Telomere length of peripheral blood mononuclear cells (PBMCs) will be measured using PCR at baseline, 4 and 8 weeks. 6. DNA methylation will be measured using an assay for transposase-accessible chromatin with sequencing (ATAC-seq) at baseline, 4 and 8 weeks. | — |
Countries
Tanzania
Contacts
Public ContactGodfrey Temba
Outcome results
None listed