Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 4 for:    ketogenic diet | covid-19

Diet and COVID-19 Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05163743
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
Lucio Gnessi, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Low Calorie Ketogenic Diet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COVID-19 Vaccination in Subjects With Obesity: Impact of Metabolic Health and the Role of a Ketogenic Diet
Actual Study Start Date : May 23, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketogenic Diet-obese
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
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 Measures :
  1. AntiSARS-CoV-2 antibodies [ Time Frame: 5 weeks ]
    antibodies will be quantified by enzyme-linked immunosorbent assay at week 0 and 5

  2. Cell mediated response to SARS CoV-2 [ Time Frame: 5 weeks ]
    whole blood will be stimulated with immune ligands within 8 h from blood collection.


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 5 weeks ]
    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.

  2. Waist Circumference [ Time Frame: 5 weeks ]
    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.

  3. Triglycerides, glucose, insulin, ESR, CRP, ferritin [ Time Frame: 5 weeks ]
    All biochemical parameters will be measured according to local laboratory standards.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05163743


Contacts
Layout table for location contacts
Contact: Lucio Gnessi, MD PhD +390649970721 lucio.gnessi@uniroma1.it
Contact: Mikiko Watanabe, MD +393483244207 mikiko.watanabe@uniroma1.it

Locations
Layout table for location information
Italy
Sapienza University of Rome Recruiting
Roma, Italy, 00185
Contact: Lucio Gnessi, MD PhD    +390649960721    lucio.gnessi@uniroma1.it   
Contact: Mikiko Watanabe, MD    +393483244207    mikiko.watanabe@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Layout table for investigator information
Principal Investigator: Lucio Gnessi, MD PhD Sapienza University of Rome
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Lucio Gnessi, Principal Investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT05163743    
Other Study ID Numbers: KDC19090421
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lucio Gnessi, University of Roma La Sapienza:
Ketogenic Diet, COVID-19, VAT, Obesity
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Obesity
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight