Health TrialsbyHealthPanel

Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection

ConditionsHealth BehaviorChild DevelopmentAdolescent Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorIndonesia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotics

    Dietary supplement

    Combination of 3 probiotic strains: Lactobacillus rhamnosus (LGG), Bifidobacterium animalis subsp. lactis (BB-12), and Lactobacillus acidophilus (LA-5)

  • Counselling on healthy eating, physical activity, and psychosocial stimulation

    Behavioral

    Counselling on healthy eating, physical activity, and psychosocial stimulation.

  • Placebo probiotics

    Dietary supplement

    Maltodextrin

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: ControlPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

BMI-for-age z-scores (BAZ)

Change in BAZ obtain from anthropometric measurements, i.e., weight (kg) and height (m) converted to BMI

Time frame
5, 10, 15, and 20 weeks
2

Immunoglobulin G (IgG) specific to SARS-COV-2 titer concentrations

Change in IgG specific to SARS-COV-2 titer concentrations assessed by electro chemiluminescence immunoassay (ECLIA)

Time frame
10 and 20 weeks

Secondary outcomes

1

α-gut microbiota diversity

Change in α-diversity measured by 1) Chao1, 2) phylogenetic diversity, and 3) the Shannon index.

Time frame
20 weeks
2

β-gut microbiota diversity

Change in β -diversity: as the variability in community composition (the identity of taxa observed) among samples

Time frame
20 weeks
3

Monoclonal antibody affinity against SARS-COV-2

Change in equilibrium dissociation constant (KD) of monoclonal antibody against SARS-COV-2 spike protein measured by competitive ELISA

Time frame
10 and 20 weeks
4

Secretory Immunoglobulin A (sIgA) specific to SARS-COV-2 titer concentrations

Change in sIgA specific to SARS-COV-2 titer concentrations assessed by competitive ELISA

Time frame
10 and 20 weeks

Other outcomes

1

SARS-COV-2 infection

Changes in proportion of symptomatic COVID-19 and positive PCR

Time frame
20 weeks
2

Body height

Changes in height-for-age z-score by anthropometric measurement

Time frame
5, 10, 15, and 20 weeks
3

Abdominal obesity (waist circumference)

Changes in waist circumference by anthropometric measurement

Time frame
5, 10, 15, and 20 weeks
4

Abdominal obesity (waist-hip ratio)

Changes in waist-hip ratio by anthropometric measurement

Time frame
5, 10, 15, and 20 weeks

Sponsors and contacts

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Indonesia University

Lead sponsor

Gadjah Mada University

Collaborator

Universitas Airlangga

Collaborator

University of Melbourne

Collaborator

The Indonesia Endowment Funds for Education, Ministry of Finance Indonesia

Collaborator

Source ClinicalTrials.gov
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