Nutrition, Immunity, and Covid-19 in Obese People

NCT04979065 | Completed Phase 2 DMC

• 1 other identifier: NICO
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Probiotics; Vitamin D; Immune status; Covid-19; Nutrition

Outcome Measures

Primary Outcomes (2)

• Zonulin level

  To investigate the changes of Zonulin level during intervention

  Baseline and endline (3 month)

• Vitamin D level

  To investigate the changes of Vitamin D level during intervention

  Baseline and endline (3 month)

Secondary Outcomes (7)

• Nutritional status

  Baseline and endline (3 month)

• Gut microbiota (optional)

  Baseline and endline (3 month)

• Inflammation marker

  Screening

• Cathelicidin level

  Screening

• SARS COV-2

  Screening

Study Arms (2)

Experimental Group

EXPERIMENTAL

Probiotics and Vitamin D

Dietary Supplement: Probiotics, Vitamin D

Control Group

PLACEBO COMPARATOR

Placebo and placebo

Other: Placebo

Interventions

Probiotics, Vitamin D DIETARY_SUPPLEMENT

Combination of two supplement that given separately

Experimental Group

Placebo OTHER

Placebo with inactive ingredient

Control Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old
• Willing to sign informed consent
• Willing to follow the research to completion
• BMI \> 23 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia: collaborator

Study Sites (4)

Wisma Emergency COVID-19 Hospital (RSDC)

Jakarta, DKI Jakarta, 10640, Indonesia

Location

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

Location

Dr.Cipto Mangunkusumo General Hospital (RSCM)

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

University of Indonesia Hospital (RSUI)

Depok, West Java, 16424, Indonesia

Location

Related Publications (9)

• 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. doi: 10.1016/s0140-6736(03)14630-2.

  PMID: 14585636 BACKGROUND

• 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.

  PMID: 32257431 BACKGROUND

• 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. No abstract available.

  PMID: 32320270 BACKGROUND

• 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. No abstract available.

  PMID: 32380044 BACKGROUND

• 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.

  PMID: 30250849 BACKGROUND

• 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):1181. doi: 10.3390/nu12041181.

  PMID: 32340216 BACKGROUND

• Childs CE, Calder PC, Miles EA. Diet and Immune Function. Nutrients. 2019 Aug 16;11(8):1933. doi: 10.3390/nu11081933.

  PMID: 31426423 BACKGROUND

• 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.

  PMID: 32215956 BACKGROUND

• 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.

  PMID: 24780623 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; COVID-19; Overweight; Obesity; Immunologic Deficiency Syndromes

Interventions

Probiotics; Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Rina Agustina, MD, PhD

  HNRC-IMERI, Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Independent party masked the intervention and control product
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Human Nutrition Research Centre / Principal Investigator

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: July 27, 2021
• Study Start: July 24, 2021
• Primary Completion: April 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (4)