Nutrition, Immunity, and Covid-19 in Obese People

NCT ID: NCT04979065

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-24
• Study Completion Date: 2022-12-30

Brief Summary

The increased risk of transmission of COVID-19 infection causes the incidence of death in health workers to escalate. It requires further research on risk factors and intervention in health worker professionals, especially on immunity factors and nutritional status. Quality of diet and nutrition is very important to support the immune system when infected. Several probiotic strains have been shown to decrease the duration and incidence of diarrhea and respiratory infections, suggesting the Gut-Lung Axis pathway. Some probiotics also improve the balance of diversity in the composition of the gut microbiota and affect body weight in obese people. Probiotics have also been shown to improve vitamin D absorption. A combination of vitamin D and probiotics may be an alternative to reduce gut dysbiosis that will directly or indirectly reduce the risk and severity of viral infections including SARS-CoV-2.

Detailed Description

Obesity is increasing in Indonesia and is the cause of various diseases, especially in the presence of Vitamin D deficiency, a state of dysbiosis, causing an increase in the possibility of infection. Professional health workers have a high risk of COVID-19 due to high daily exposure. Based on a review conducted by Daniel et al, it was found that 7.3% of health workers at Reutters University tested positive for COVID-19. Based on data from the Indonesian Doctors Association (IDI) on July 12, 2020, it was known that 61 doctors had died. In addition, based on data from the Indonesian National Nurses Association (PPNI), 39 nurses have died during the COVID-19 pandemic. Therefore efforts to prevent the occurrence of COVID-19 infection by providing a combination of vitamin D and probiotics to modulate dysbiosis that will further reduce the risk of viral infection, especially COVID-19, needs to be investigated for its potential benefits.

Primary and secondary objectives

1. Primary Objective:

To investigate the effect of a combination of probiotics and vitamin D supplementation in modulating intestinal dysbiosis, and vitamin D status, in people with overweight and obesity, especially among frontline health workers.

• To assess the mean changes in zonulin levels (as a parameter of gut integrity to indicate the intestinal microbiota dysbiosis)
• To assess the mean changes in serum vitamin D levels

2. Secondary Objectives:

• To assess the relationship between nutritional status, inflammation and immunity with the risk of COVID-19 infection in health workers.
• To understand the difference in the mean episodes of Covid-19 infection between treatment and placebo groups after giving probiotics and vitamin D in people with overweight and obesity, especially among frontline health workers.

Study Design:

This study has 2 phases Phase 1: a Cross-sectional study with 160 people Phase 2: a double-blind, randomized, placebo-controlled trial with two arms of intervention involving a total of 80 people.

Conditions

Vitamin D Deficiency; Covid19; Overweight and Obesity; Immune Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Group

Probiotics and Vitamin D

Group Type: EXPERIMENTAL

Probiotics, Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Combination of two supplement that given separately

Control Group

Placebo and placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo with inactive ingredient

Interventions

Probiotics, Vitamin D

Combination of two supplement that given separately

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo with inactive ingredient

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• General doctors, specialist doctors, nurses and midwives who are in charge of handling COVID-19 patients or working in COVID-19 referral hospitals for at least the last 3 months
• 20-65 years old
• Willing to sign informed consent
• Willing to follow the research to completion
• BMI > 23 kg/m2

Exclusion Criteria

• Pregnant woman
• Have a confirmed history of COVID-19 based on previous PCR examinations
• Suffering from acute illness known from history and physical examination or chronic disease (eg diabetes, SLE, cardiovascular disease) known from history
• Currently not on a diet program for weight loss or consuming probiotics regularly in the last 3 months as known from the anamnesis

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

OTHER_GOV

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Prof Rina Agustina, MD, PhD

Head of Human Nutrition Research Centre / Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rina Agustina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HNRC-IMERI, Faculty of Medicine Universitas Indonesia

Locations

Wisma Emergency COVID-19 Hospital (RSDC)

Jakarta, DKI Jakarta, Indonesia

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

Dr.Cipto Mangunkusumo General Hospital (RSCM)

Jakarta Pusat, DKI Jakarta, Indonesia

University of Indonesia Hospital (RSUI)

Depok, West Java, Indonesia

Countries

Indonesia

References

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Reference Type: BACKGROUND

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Other Identifiers

NICO

Identifier Type: -

Identifier Source: org_study_id