Nutrition, Immunity, and Covid-19 in Obese People

Covid19 Clinical Trial

— NICO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979065
• Other study ID #: NICO
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2022
• Source: Indonesia University
• Contact: Rina Agustina, MD, PhD
• Phone: +62213912477
• Email: dr.rinaagustina[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Immune Deficiency
• Immunologic Deficiency Syndromes
• Overweight
• Overweight and Obesity
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Probiotics, Vitamin D
Combination of two supplement that given separately

Other:
• Placebo
Placebo with inactive ingredient

Locations

Country	Name	City	State
Indonesia	University of Indonesia Hospital (RSUI)	Depok	West Java
Indonesia	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

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

Calder PC, Carr AC, Gombart AF, Eggersdorfer M. Optimal Nutritional Status for a Well-Functioning Immune System Is an Important Factor to Protect against Viral Infections. Nutrients. 2020 Apr 23;12(4). pii: E1181. doi: 10.3390/nu12041181. Review. — View Citation

Childs CE, Calder PC, Miles EA. Diet and Immune Function. Nutrients. 2019 Aug 16;11(8). pii: E1933. doi: 10.3390/nu11081933. — View Citation

Kass DA, Duggal P, Cingolani O. Obesity could shift severe COVID-19 disease to younger ages. Lancet. 2020 May 16;395(10236):1544-1545. doi: 10.1016/S0140-6736(20)31024-2. Epub 2020 May 4. — View Citation

King S, Glanville J, Sanders ME, Fitzgerald A, Varley D. Effectiveness of probiotics on the duration of illness in healthy children and adults who develop common acute respiratory infectious conditions: a systematic review and meta-analysis. Br J Nutr. 2014 Jul 14;112(1):41-54. doi: 10.1017/S0007114514000075. Epub 2014 Apr 29. Review. — View Citation

Nagpal R, Newman TM, Wang S, Jain S, Lovato JF, Yadav H. Obesity-Linked Gut Microbiome Dysbiosis Associated with Derangements in Gut Permeability and Intestinal Cellular Homeostasis Independent of Diet. J Diabetes Res. 2018 Sep 3;2018:3462092. doi: 10.1155/2018/3462092. eCollection 2018. — View Citation

Sattar N, McInnes IB, McMurray JJV. Obesity Is a Risk Factor for Severe COVID-19 Infection: Multiple Potential Mechanisms. Circulation. 2020 Jul 7;142(1):4-6. doi: 10.1161/CIRCULATIONAHA.120.047659. Epub 2020 Apr 22. — View Citation

Shereen MA, Khan S, Kazmi A, Bashir N, Siddique R. COVID-19 infection: Origin, transmission, and characteristics of human coronaviruses. J Adv Res. 2020 Mar 16;24:91-98. doi: 10.1016/j.jare.2020.03.005. eCollection 2020 Jul. Review. — View Citation

Wong SH, Lui RN, Sung JJ. Covid-19 and the digestive system. J Gastroenterol Hepatol. 2020 May;35(5):744-748. doi: 10.1111/jgh.15047. Epub 2020 Apr 19. Review. — View Citation

Zhong NS, Zheng BJ, Li YM, Poon, Xie ZH, Chan KH, Li PH, Tan SY, Chang Q, Xie JP, Liu XQ, Xu J, Li DX, Yuen KY, Peiris, Guan Y. Epidemiology and cause of severe acute respiratory syndrome (SARS) in Guangdong, People's Republic of China, in February, 2003. Lancet. 2003 Oct 25;362(9393):1353-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zonulin level	To investigate the changes of Zonulin level during intervention	Baseline and endline (3 month)
Primary	Vitamin D level	To investigate the changes of Vitamin D level during intervention	Baseline and endline (3 month)
Secondary	Nutritional status	Measurement of nutritional status using Body Mass Index (BMI) and waist circumference	Baseline and endline (3 month)
Secondary	Gut microbiota (optional)	Measurement of gut microbiota in fecal using Next Generation Sequencing	Baseline and endline (3 month)
Secondary	Inflammation marker	Measurement of inflammation markers IL-6, IL-10 TNF-a using ELISA	Screening
Secondary	Cathelicidin level	Measurement of cathelicidin using ELISA	Screening
Secondary	SARS COV-2	Measurement of quantitative antibody	Screening
Secondary	CD4/CD8 ratio	Measurement of CD4/CD8 ratio using flowcytometry	Screening
Secondary	Covid-19 infection	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.	Baseline and endline (3 month)