Diet and COVID-19 Vaccination

Obesity Clinical Trial

Official title:

COVID-19 Vaccination in Subjects With Obesity: Impact of Metabolic Health and the Role of a Ketogenic Diet

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163743
• Other study ID #: KDC19090421
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2021
• Est. completion date: December 2021

Study information

• Verified date: December 2021
• Source: University of Roma La Sapienza
• Contact: Lucio Gnessi, MD PhD
• Phone: +390649970721
• Email: lucio.gnessi[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recently, obesity and excess visceral fat were shown to be major risk factors for the development of complications following Covid 19 infection. Recently, KDs have been suggested as possible weapons to tame the cytokine storm being described in those developing complications upon COVID-19 infection, and preclinical evidence strongly supports the hypothesis, with mouse models of COVID-19 infection in the elderly reporting strikingly better outcomes upon consumption of a KD. Short-term interventions that use low-calorie ketogenic diets may be prescribed for selected overweight or obese patients with type 2 diabetes or prediabetes.

No data is available on the impact of a ketogenic diet on immune modulation following vaccination. We herein aim at investigating whether obesity and unhealthy body composition are associated with poor seroconversion following the upcoming COVID-19 vaccine administration, and whether consumption of a KD before and between COVID-19 vaccine doses leads to better immune response in obese subjects. 24 obese patients will be assigned to follow a LCKD regimen for 5 weeks.

Description:

Recently, obesity and excess visceral fat were shown to be major risk factors for the development of complications following Covid 19 infection. Recently, KDs have been suggested as possible weapons to tame the cytokine storm being described in those developing complications upon COVID-19 infection, and preclinical evidence strongly supports the hypothesis, with mouse models of COVID-19 infection in the elderly reporting strikingly better outcomes upon consumption of a KD. Short-term interventions that use low-calorie ketogenic diets may be prescribed for selected overweight or obese patients with type 2 diabetes or prediabetes.

No data is available on the impact of a ketogenic diet on immune modulation following vaccination. We herein aim at investigating whether obesity and unhealthy body composition are associated with poor seroconversion following the upcoming COVID-19 vaccine administration, and whether consumption of a KD before and between COVID-19 vaccine doses leads to better immune response in obese subjects. 24 patients will be assigned to follow a low-calorie ketogenic diet (LCKD). Outcome measures will be antiSARS-CoV-2 antibodies, cell mediated response to SARS CoV-2, anthropometric parameters, vital signs, metabolic profile, and body composition. The patients will be assessed at baseline (T0) and every two weeks (T1, T2) as they receive both SARS Cov-2 vaccination doses up to 1 week after the second dose (T3) when they will be finally evaluated and carbohydrate reintroduction takes place. Patients will be given support and counselling to enhance their compliance. Anthropometric parameters such as body weight, blood pressure (systolic and diastolic), heart rate, waist and hip circumference will be measured at baseline (T0), every two weeks up to the end of the trial (T3).

Blood and urine chemistry Complete Blood Count (CBC), electrolytes (chloride, calcium, potassium, sodium, magnesium), fasting glucose, insulin, lipids (total and fractionated cholesterol and triglycerides) and proteins, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), plasma creatinine, blood urea nitrogen (BUN), alanine transferase (AST), aspartate transaminase (ALT), uric acid, beta hydroxy butyrate and estimated Glomerular Filtration Rate (using the Modification of Diet in Renal Disease study equation MDRD-eGFR) will be determined

AntiSARS-CoV-2 antibodies: antibodies will be quantified by enzyme-linked immunosorbent assay using the appropriate antigen at T3 and T4 in all arms. The cell mediated response to SARS CoV-2 will be analyzed by taking whole blood that will be stimulated with immune ligands.

Data obtained will be expressed as mean values ±Standard Deviation (SD) and finally processed to ascertain whether statistical differences among them can be demonstrated, using appropriate methods. In particular, the analysis of variance (ANOVA) at different times will be used for efficacy and safety data, such as weight reduction, changes in anthropometric measures, and variation of the metabolic parameters. P values <0.05 will be considered statistically significant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• BMI =35.0 kg/m2 with comorbidities or BMI=40

• Stable body weight (less than 5 kg self-reported change during the previous 3 months)

• Informed consent obtained before any trial-related activity takes place Exclusion criteria

• Stage 3-5 CKD (GFR<60 ml/min)

• Type 1 diabetes

• Uncontrolled type 2 diabetes

• Previous infection with SARS CoV-2

• Immunodeficiency or immunomodulating treatment

• Treatment with anti-obesity medications or other medications potentially affecting body weight or SGLT2 inhibitors

• Pregnancy and lactation

• Previous gout episodes

• Cardio and cerebrovascular accidents in the preceding 12 months

Related Conditions & MeSH terms

• COVID-19
• Obesity

Intervention

Dietary Supplement:
• Low Calorie Ketogenic Diet
The very low-carbohydrate diet will be hypo caloric and aim to provide less than 50 g of carbohydrates per day. the participants will be counseled to choose vegetarian and healthy sources of fat and protein and to avoid trans fat. Then, gradual reintroduction of carbohydrates will take place following the second vaccine dose.

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (24)

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Watanabe M, Caruso D, Tuccinardi D, Risi R, Zerunian M, Polici M, Pucciarelli F, Tarallo M, Strigari L, Manfrini S, Mariani S, Basciani S, Lubrano C, Laghi A, Gnessi L. Visceral fat shows the strongest association with the need of intensive care in patients with COVID-19. Metabolism. 2020 Oct;111:154319. doi: 10.1016/j.metabol.2020.154319. Epub 2020 Jul 23. — View Citation

Watanabe M, Risi R, De Giorgi F, Tuccinardi D, Mariani S, Basciani S, Lubrano C, Lenzi A, Gnessi L. Obesity treatment within the Italian national healthcare system tertiary care centers: what can we learn? Eat Weight Disord. 2021 Apr;26(3):771-778. doi: 10.1007/s40519-020-00936-1. Epub 2020 May 25. Review. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AntiSARS-CoV-2 antibodies	antibodies will be quantified by enzyme-linked immunosorbent assay at week 0 and 5	5 weeks
Primary	Cell mediated response to SARS CoV-2	whole blood will be stimulated with immune ligands within 8 h from blood collection.	5 weeks
Secondary	Body weight	Body weight will be obtained with the subjects wearing very light clothing and no shoes, and with an empty bladder. The same scale will be used throughout the study. The scale will be calibrated.	5 weeks
Secondary	Waist Circumference	Waist circumference will be measured on subjects while semi clothed, standing with their feet close together and their weight equally distributed on each leg. Subjects will be asked to breath normally. Circumference will be taken at the midpoint between the lower rib margin and the iliac crest.	5 weeks
Secondary	Triglycerides, glucose, insulin, ESR, CRP, ferritin	All biochemical parameters will be measured according to local laboratory standards.	5 weeks

External Links

•   Obesity and Overweight Factsheet June 2016 [08/04/2017].