Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
Recruiting · NCT05623007 · Interventional (participants receive a specific treatment) · Lead sponsor: Indonesia University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Probiotic intervention has been currently suggested to provide supportive benefits in promoting health, including alleviating disease symptoms, protecting against diarrhea and respiratory infection, affecting growth and modulating the immune system by improving the beneficial gut microbiota colonization, giving direction on the gut-lung-axis pathway. This indicates that probiotics may become alternative to improve nutrition and reduce the risk of viral infections which may reduce the risk against Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2). Introduction to probiotics during adolescence can alleviate inflammation and invert dysbiosis. However, evidence on the effect of probiotic supplementation on enhancing antibody response to SARS COV-2 in adolescents is lacking. Moreover, previous studies showed the potential effect of probiotic supplementation to improve overweight and obesity in adolescents. A bi-directional relationship exists among nutrition, infection, and immunity as changes in one element will affect the others. The main objective of this study is to investigate the effect of dietary modulation of overweight and obese adolescent's gut microbiota through probiotic supplementation combined with healthy eating and physical activity counseling and psychosocial stimulation on nutritional status and antibody response to COVID-19 vaccination. This trial will conduct a 20-week intervention for overweight and obese adolescents.
Who can take part
Inclusion criteria
- living in Jakarta, Surabaya, and Yogyakarta City for at least 6 months permanently;
- apparently healthy;
- male and female, age 12-17 years old;
- overweight or obese (BMI-for-age z-score \>+1SD);
- have completed at least two dosages of COVID-19 vaccine, the vaccine must be CoronaVac® (Sinovac);
- minimal 6 months post vaccinated prior to recruitments.
- parents willing to sign the informed consent and adolescents give informed assent;
- Must have an active health insurance, for instance BPJS or similar health insurance.
Exclusion criteria
- having a history of COVID-19 infection within the last month confirmed by PCR or antigen from health care facilities or independent laboratory;
- having a history of chronic and non-communicable diseases, congenital diseases, and disabilities;
- reported current diagnosed as suspected active Tuberculosis (primary lung TB, miliary TB, bleeding cough bone TB, meningitis TB);
- having a history of gastrointestinal or malabsorption disorder (such as celiac disease and inflammatory bowel disease) within the last three months or during the study;
- taking antibiotics during 2 weeks before the start of the study (adolescents will be included after 3 weeks of last antibiotic intake);
- taking other medications or having diseases that may influence the immune response - i.e. immune deficiencies, immunosuppressants medications, blood transfusion or other blood products;
- taking insulin and/or anti-dyslipidemia medication;
- being pregnant and/or breastfeeding.
Where it is running
1 location listed.
- Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia - Jakarta Pusat, DKI Jakarta, Indonesia