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

NCT05623007 | Recruiting DMC

• 1 other identifier: DIVINE
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Behavior; Child Development; Adolescent Obesity

Keywords

adolescent; probiotics; COVID-19; overweight; obese

Outcome Measures

Primary Outcomes (2)

• BMI-for-age z-scores (BAZ)

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

  5, 10, 15, and 20 weeks

• 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)

  10 and 20 weeks

Secondary Outcomes (5)

• α-gut microbiota diversity

  20 weeks

• β-gut microbiota diversity

  20 weeks

• Monoclonal antibody affinity against SARS-COV-2

  10 and 20 weeks

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

  10 and 20 weeks

• Dietary quality

  5, 10, 15, and 20 weeks

Other Outcomes (22)

• SARS-COV-2 infection

  20 weeks

• Body height

  5, 10, 15, and 20 weeks

• Abdominal obesity (waist circumference)

  5, 10, 15, and 20 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

220 overweight/obese adolescents will be given Probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.

Dietary Supplement: Probiotics; Behavioral: Counselling on healthy eating, physical activity, and psychosocial stimulation

Control

PLACEBO COMPARATOR

220 overweight/obese adolescents will be given placebo probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.

Behavioral: Counselling on healthy eating, physical activity, and psychosocial stimulation; Dietary Supplement: Placebo probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

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

Intervention

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

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

Control; Intervention

Placebo probiotics DIETARY_SUPPLEMENT

Maltodextrin

Control

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead
• Gadjah Mada University: collaborator
• Universitas Airlangga: collaborator
• University of Melbourne: collaborator
• The Indonesia Endowment Funds for Education, Ministry of Finance Indonesia: collaborator

Study Sites (1)

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, 10430, Indonesia

RECRUITING

Related Publications (5)

• Petta I, Fraussen J, Somers V, Kleinewietfeld M. Interrelation of Diet, Gut Microbiome, and Autoantibody Production. Front Immunol. 2018 Mar 6;9:439. doi: 10.3389/fimmu.2018.00439. eCollection 2018.

  PMID: 29559977 BACKGROUND

• Rajput S, Paliwal D, Naithani M, Kothari A, Meena K, Rana S. COVID-19 and Gut Microbiota: A Potential Connection. Indian J Clin Biochem. 2021 Jul;36(3):266-277. doi: 10.1007/s12291-020-00948-9. Epub 2021 Jan 21.

  PMID: 33495676 BACKGROUND

• Agustina R, Kok FJ, van de Rest O, Fahmida U, Firmansyah A, Lukito W, Feskens EJ, van den Heuvel EG, Albers R, Bovee-Oudenhoven IM. Randomized trial of probiotics and calcium on diarrhea and respiratory tract infections in Indonesian children. Pediatrics. 2012 May;129(5):e1155-64. doi: 10.1542/peds.2011-1379. Epub 2012 Apr 9.

  PMID: 22492764 BACKGROUND

• Abenavoli L, Scarpellini E, Colica C, Boccuto L, Salehi B, Sharifi-Rad J, Aiello V, Romano B, De Lorenzo A, Izzo AA, Capasso R. Gut Microbiota and Obesity: A Role for Probiotics. Nutrients. 2019 Nov 7;11(11):2690. doi: 10.3390/nu11112690.

  PMID: 31703257 BACKGROUND

• Agustina R, Ekawidyani KR, Mutiyani M, Prafiantini E, Nindya TS, Damayanti W, Rejeki PS, Djuari L, Huriyati E, Bines JE, Juffrie M. Study protocol for a randomised controlled trial evaluating the efficacy of dietary modulation of probiotics on nutritional status and antibody response to SARS-CoV-2 in Indonesian adolescents: gut-lung axis (DIVINE). BMJ Open. 2025 Apr 2;15(4):e087934. doi: 10.1136/bmjopen-2024-087934.

  PMID: 40180370 DERIVED

MeSH Terms

Conditions

Health Behavior; Pediatric Obesity; COVID-19; Overweight; Obesity

Interventions

Probiotics; Exercise

Condition Hierarchy (Ancestors)

Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rina Agustina, PhD

  Dep of Nutrition and Human Nutrition Research Center, IMERI, Fac of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rina Agustina, PhD

CONTACT

+622129189160; dr.rinaagustina@gmail.com

Rahyussalim Rahyussalim, PhD

CONTACT

+622129189160; manajer.riset.fkui1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Enumerator, Investigator, Outcomes Assessor) Participant, enumerator, investigator, and outcomes assessor do not know which one is the intervention product or placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The product will be given to 440 overweight/obese adolescents, 220 adolescents as an intervention group, and 220 overweight/obese adolescents as a control group

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 21, 2022
• Study Start: November 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)