Diet and COVID-19 Vaccination

NCT05163743 | Unknown

• 1 other identifier: KDC19090421
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Ketogenic Diet, COVID-19, VAT, Obesity

Outcome Measures

Primary Outcomes (2)

• AntiSARS-CoV-2 antibodies

  antibodies will be quantified by enzyme-linked immunosorbent assay at week 0 and 5

  5 weeks

• Cell mediated response to SARS CoV-2

  whole blood will be stimulated with immune ligands within 8 h from blood collection.

  5 weeks

Secondary Outcomes (3)

• Body weight

  5 weeks

• Waist Circumference

  5 weeks

• Triglycerides, glucose, insulin, ESR, CRP, ferritin

  5 weeks

Study Arms (1)

Ketogenic Diet-obese

EXPERIMENTAL

LCKD (1200-1400kcal/day) low in carbohydrates (\<50g per day) with a moderate protein intake (1-1.5g/kg of ideal body mass) but otherwise no other dietary restrictions. The participants will be counselled by a trained nutritionist at baseline and every two weeks, and compliance will be assessed through a 3-day dietary recall at each follow up visit and capillary beta hydroxybutyrate levels as well as urinary acetoacetate levels. The follow up visits take place at the time of the first vaccine dose, two weeks after the first vaccine dose, one week after the second vaccine dose. Then, gradual reintroduction of carbohydrates will take place following the second vaccine dose.

Dietary Supplement: Low Calorie Ketogenic Diet

Interventions

Low Calorie Ketogenic Diet DIETARY_SUPPLEMENT

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.

Ketogenic Diet-obese

Eligibility Criteria

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Roma, 00185, Italy

RECRUITING

Related Publications (24)

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Related Links

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

MeSH Terms

Conditions

Obesity; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Lucio Gnessi, MD PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucio Gnessi, MD PhD

CONTACT

+390649970721; lucio.gnessi@uniroma1.it

Mikiko Watanabe, MD

CONTACT

+393483244207; mikiko.watanabe@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: December 20, 2021
• Study Start: May 23, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)