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Diet and COVID-19 Vaccination

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Low Calorie Ketogenic Diet
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Ketogenic Diet, COVID-19, VAT, Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • 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

Sites / Locations

  • Sapienza University of RomeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketogenic Diet-obese

Arm Description

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.

Outcomes

Primary Outcome Measures

AntiSARS-CoV-2 antibodies
antibodies will be quantified by enzyme-linked immunosorbent assay at week 0 and 5
Cell mediated response to SARS CoV-2
whole blood will be stimulated with immune ligands within 8 h from blood collection.

Secondary Outcome Measures

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.
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.
Triglycerides, glucose, insulin, ESR, CRP, ferritin
All biochemical parameters will be measured according to local laboratory standards.

Full Information

First Posted
December 16, 2021
Last Updated
December 16, 2021
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT05163743
Brief Title
Diet and COVID-19 Vaccination
Official Title
COVID-19 Vaccination in Subjects With Obesity: Impact of Metabolic Health and the Role of a Ketogenic Diet
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Ketogenic Diet, COVID-19, VAT, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic Diet-obese
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Calorie Ketogenic Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
AntiSARS-CoV-2 antibodies
Description
antibodies will be quantified by enzyme-linked immunosorbent assay at week 0 and 5
Time Frame
5 weeks
Title
Cell mediated response to SARS CoV-2
Description
whole blood will be stimulated with immune ligands within 8 h from blood collection.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
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.
Time Frame
5 weeks
Title
Waist Circumference
Description
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.
Time Frame
5 weeks
Title
Triglycerides, glucose, insulin, ESR, CRP, ferritin
Description
All biochemical parameters will be measured according to local laboratory standards.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucio Gnessi, MD PhD
Phone
+390649970721
Email
lucio.gnessi@uniroma1.it
First Name & Middle Initial & Last Name or Official Title & Degree
Mikiko Watanabe, MD
Phone
+393483244207
Email
mikiko.watanabe@uniroma1.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucio Gnessi, MD PhD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sapienza University of Rome
City
Roma
ZIP/Postal Code
00185
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucio Gnessi, MD PhD
Phone
+390649960721
Email
lucio.gnessi@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Mikiko Watanabe, MD
Phone
+393483244207
Email
mikiko.watanabe@uniroma1.it

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.who.int/mediacentre/factsheets/fs311/en/
Description
Obesity and Overweight Factsheet June 2016 [08/04/2017].

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Diet and COVID-19 Vaccination

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