NICO: Nutrition, Immunity, and Covid-19 in Obese People

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04979065

Collaborator

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia (Other)

Enrollment

Locations

Arms

17.2

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Covid19 Overweight and Obesity Immune Deficiency	Dietary Supplement: Probiotics, Vitamin D Other: Placebo	N/A

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

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Independent party will mask the product

Primary Purpose:

Prevention

Official Title:

Effect of Probiotic and Vitamin D Supplementation in Modulating Gut Dysbiosis, Nutrition, Inflammation and Immune Status and Reduce Risk of COVID-19 in Obese People: Gut-Lung Axis Randomized Trial

Actual Study Start Date :

Jul 24, 2021

Actual Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Probiotics and Vitamin D	Dietary Supplement: Probiotics, Vitamin D Combination of two supplement that given separately
Placebo Comparator: Control Group Placebo and placebo	Other: Placebo Placebo with inactive ingredient

Arm

Intervention/Treatment

Experimental: Experimental Group

Probiotics and Vitamin D

Dietary Supplement: Probiotics, Vitamin D

Combination of two supplement that given separately

Placebo Comparator: Control Group

Placebo and placebo

Other: Placebo

Placebo with inactive ingredient

Outcome Measures

Primary Outcome Measures

Zonulin level [Baseline and endline (3 month)]
To investigate the changes of Zonulin level during intervention
Vitamin D level [Baseline and endline (3 month)]
To investigate the changes of Vitamin D level during intervention

Secondary Outcome Measures

Nutritional status [Baseline and endline (3 month)]
Measurement of nutritional status using Body Mass Index (BMI) and waist circumference
Gut microbiota (optional) [Baseline and endline (3 month)]
Measurement of gut microbiota in fecal using Next Generation Sequencing
Inflammation marker [Screening]
Measurement of inflammation markers IL-6, IL-10 TNF-α using ELISA
Cathelicidin level [Screening]
Measurement of cathelicidin using ELISA
SARS COV-2 [Screening]
Measurement of quantitative antibody
CD4/CD8 ratio [Screening]
Measurement of CD4/CD8 ratio using flowcytometry
Covid-19 infection [Baseline and endline (3 month)]
Measurement of the reduction in risk of COVID-19 infection is seen from the difference in the average episodes between groups that were examined by PCR and/or Rapid antibody tests.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	Indonesia	10430
2	Dr.Cipto Mangunkusumo General Hospital (RSCM)	Jakarta Pusat	DKI Jakarta	Indonesia	10430
3	Wisma Emergency COVID-19 Hospital (RSDC)	Jakarta	DKI Jakarta	Indonesia	10640
4	University of Indonesia Hospital (RSUI)	Depok	West Java	Indonesia	16424