ObesityNCT05163743
Diet and COVID-19 Vaccination
A study testing Low Calorie Ketogenic Diet in people with Obesity, run by University of Roma La Sapienza at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low Calorie Ketogenic Diet
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Sapienza University of Rome
Roma, 00185
Lucio Gnessi, MD PhD, +390649960721, lucio.gnessi@uniroma1.it
Mikiko Watanabe, MD, +393483244207, mikiko.watanabe@uniroma1.it
About this study
Official title: COVID-19 Vaccination in Subjects With Obesity: Impact of Metabolic Health and the Role of a Ketogenic Diet
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Low Calorie Ketogenic Diet
- Keywords
- Ketogenic Diet, COVID-19, VAT, Obesity
- Medical subject headings
- Obesity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Calorie Ketogenic DietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Low Calorie Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AntiSARS-CoV-2 antibodies
antibodies will be quantified by enzyme-linked immunosorbent assay at week 0 and 5
Measured: 5 weeks
Cell mediated response to SARS CoV-2
whole blood will be stimulated with immune ligands within 8 h from blood collection.
Measured: 5 weeks
Secondary outcomes (3)
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Triglycerides, glucose, insulin, ESR, CRP, ferritin
All biochemical parameters will be measured according to local laboratory standards.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start23 May 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucio Gnessi, University of Roma La Sapienza
- Investigators
- Lucio Gnessi, MD PhD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163743
- Sponsor's protocol ID
- KDC19090421
- Status last verified
- Dec 2021
- First submitted
- 16 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32451949Mariani S, Fiore D, Varone L, Basciani S, Persichetti A, Watanabe M, Saponara M, Spera G, Moretti C, Gnessi L. Obstructive sleep apnea and bone mineral density in obese patients. Diabetes Metab Syndr Obes. 2012;5:395-401. doi: 10.2147/DMSO.S37761. Epub 2012 Nov 7.
PubMed 23152692Lonardo A, Mantovani A, Lugari S, Targher G. Epidemiology and pathophysiology of the association between NAFLD and metabolically healthy or metabolically unhealthy obesity. Ann Hepatol. 2020 Jul-Aug;19(4):359-366. doi: 10.1016/j.aohep.2020.03.001. Epub 2020 Mar 21.
PubMed 32349939Dwivedi AK, Dubey P, Cistola DP, Reddy SY. Association Between Obesity and Cardiovascular Outcomes: Updated Evidence from Meta-analysis Studies. Curr Cardiol Rep. 2020 Mar 12;22(4):25. doi: 10.1007/s11886-020-1273-y.
PubMed 32166448Okamura T, Hashimoto Y, Hamaguchi M, Obora A, Kojima T, Fukui M. Ectopic fat obesity presents the greatest risk for incident type 2 diabetes: a population-based longitudinal study. Int J Obes (Lond). 2019 Jan;43(1):139-148. doi: 10.1038/s41366-018-0076-3. Epub 2018 May 1.
PubMed 29717276Palermo A, Tuccinardi D, Defeudis G, Watanabe M, D'Onofrio L, Lauria Pantano A, Napoli N, Pozzilli P, Manfrini S. BMI and BMD: The Potential Interplay between Obesity and Bone Fragility. Int J Environ Res Public Health. 2016 May 28;13(6):544. doi: 10.3390/ijerph13060544.
PubMed 27240395Arboleda S, Vargas M, Losada S, Pinto A. Review of obesity and periodontitis: an epidemiological view. Br Dent J. 2019 Aug;227(3):235-239. doi: 10.1038/s41415-019-0611-1.
PubMed 31399683Watanabe 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.
PubMed 32712222Petrilli CM, Jones SA, Yang J, Rajagopalan H, O'Donnell L, Chernyak Y, Tobin KA, Cerfolio RJ, Francois F, Horwitz LI. Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study. BMJ. 2020 May 22;369:m1966. doi: 10.1136/bmj.m1966.
PubMed 32444366Watanabe M, Risi R, Tuccinardi D, Baquero CJ, Manfrini S, Gnessi L. Obesity and SARS-CoV-2: A population to safeguard. Diabetes Metab Res Rev. 2020 Oct;36(7):e3325. doi: 10.1002/dmrr.3325. Epub 2020 Jun 11.
PubMed 32314503McLarnon A. Obesity: influenza immunity impaired in obesity. Nat Rev Endocrinol. 2011 Nov 15;8(1):3. doi: 10.1038/nrendo.2011.199. No abstract available.
PubMed 22083087Andersen CJ, Murphy KE, Fernandez ML. Impact of Obesity and Metabolic Syndrome on Immunity. Adv Nutr. 2016 Jan 15;7(1):66-75. doi: 10.3945/an.115.010207. Print 2016 Jan.
PubMed 26773015Painter SD, Ovsyannikova IG, Poland GA. The weight of obesity on the human immune response to vaccination. Vaccine. 2015 Aug 26;33(36):4422-9. doi: 10.1016/j.vaccine.2015.06.101. Epub 2015 Jul 8.
PubMed 26163925Neidich SD, Green WD, Rebeles J, Karlsson EA, Schultz-Cherry S, Noah TL, Chakladar S, Hudgens MG, Weir SS, Beck MA. Increased risk of influenza among vaccinated adults who are obese. Int J Obes (Lond). 2017 Sep;41(9):1324-1330. doi: 10.1038/ijo.2017.131. Epub 2017 Jun 6.
PubMed 28584297Gardner CD, Trepanowski JF, Del Gobbo LC, Hauser ME, Rigdon J, Ioannidis JPA, Desai M, King AC. Effect of Low-Fat vs Low-Carbohydrate Diet on 12-Month Weight Loss in Overweight Adults and the Association With Genotype Pattern or Insulin Secretion: The DIETFITS Randomized Clinical Trial. JAMA. 2018 Feb 20;319(7):667-679. doi: 10.1001/jama.2018.0245.
PubMed 29466592
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccination in Subjects With Obesity: Impact of Metabolic Health and the Role of a Ketogenic Diet
- ClinicalTrials.gov ID
- NCT05163743
- Acronym / sponsor ID
- KDC19090421
- Conditions
- Obesity
- Keywords
- Ketogenic Diet, COVID-19, VAT, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 23 May 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet-obese | Experimental | Dietary Supplement: Low Calorie Ketogenic DietLCKD (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Calorie Ketogenic DietThe 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. | Dietary supplement | Ketogenic Diet-obese |
Primary outcome
AntiSARS-CoV-2 antibodies
Time frame: 5 weeks
antibodies will be quantified by enzyme-linked immunosorbent assay at week 0 and 5
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.
3 secondary outcomes
Body weight
Time frame: 5 weeks
Waist Circumference
Time frame: 5 weeks
Triglycerides, glucose, insulin, ESR, CRP, ferritin
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Background: PubMed 32451949Watanabe 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.
- Background: PubMed 23152692Mariani S, Fiore D, Varone L, Basciani S, Persichetti A, Watanabe M, Saponara M, Spera G, Moretti C, Gnessi L. Obstructive sleep apnea and bone mineral density in obese patients. Diabetes Metab Syndr Obes. 2012;5:395-401. doi: 10.2147/DMSO.S37761. Epub 2012 Nov 7.
- Background: PubMed 32349939Lonardo A, Mantovani A, Lugari S, Targher G. Epidemiology and pathophysiology of the association between NAFLD and metabolically healthy or metabolically unhealthy obesity. Ann Hepatol. 2020 Jul-Aug;19(4):359-366. doi: 10.1016/j.aohep.2020.03.001. Epub 2020 Mar 21.
- Background: PubMed 32166448Dwivedi AK, Dubey P, Cistola DP, Reddy SY. Association Between Obesity and Cardiovascular Outcomes: Updated Evidence from Meta-analysis Studies. Curr Cardiol Rep. 2020 Mar 12;22(4):25. doi: 10.1007/s11886-020-1273-y.
- Background: PubMed 29717276Okamura T, Hashimoto Y, Hamaguchi M, Obora A, Kojima T, Fukui M. Ectopic fat obesity presents the greatest risk for incident type 2 diabetes: a population-based longitudinal study. Int J Obes (Lond). 2019 Jan;43(1):139-148. doi: 10.1038/s41366-018-0076-3. Epub 2018 May 1.
- Background: PubMed 27240395Palermo A, Tuccinardi D, Defeudis G, Watanabe M, D'Onofrio L, Lauria Pantano A, Napoli N, Pozzilli P, Manfrini S. BMI and BMD: The Potential Interplay between Obesity and Bone Fragility. Int J Environ Res Public Health. 2016 May 28;13(6):544. doi: 10.3390/ijerph13060544.
- Background: PubMed 31399683Arboleda S, Vargas M, Losada S, Pinto A. Review of obesity and periodontitis: an epidemiological view. Br Dent J. 2019 Aug;227(3):235-239. doi: 10.1038/s41415-019-0611-1.
- Background: PubMed 32712222Watanabe 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.
- Background: PubMed 32444366Petrilli CM, Jones SA, Yang J, Rajagopalan H, O'Donnell L, Chernyak Y, Tobin KA, Cerfolio RJ, Francois F, Horwitz LI. Factors associated with hospital admission and critical illness among 5279 people with coronavirus disease 2019 in New York City: prospective cohort study. BMJ. 2020 May 22;369:m1966. doi: 10.1136/bmj.m1966.
- Background: PubMed 32314503Watanabe M, Risi R, Tuccinardi D, Baquero CJ, Manfrini S, Gnessi L. Obesity and SARS-CoV-2: A population to safeguard. Diabetes Metab Res Rev. 2020 Oct;36(7):e3325. doi: 10.1002/dmrr.3325. Epub 2020 Jun 11.
- Background: PubMed 22083087McLarnon A. Obesity: influenza immunity impaired in obesity. Nat Rev Endocrinol. 2011 Nov 15;8(1):3. doi: 10.1038/nrendo.2011.199. No abstract available.
- Background: PubMed 26773015Andersen CJ, Murphy KE, Fernandez ML. Impact of Obesity and Metabolic Syndrome on Immunity. Adv Nutr. 2016 Jan 15;7(1):66-75. doi: 10.3945/an.115.010207. Print 2016 Jan.
- Obesity and Overweight Factsheet June 2016 \[08/04/2017\].Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucio Gnessi, MD PhD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Calorie Ketogenic Diet in people with Obesity, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucio Gnessi, MD PhD (+390649970721, lucio.gnessi@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AntiSARS-CoV-2 antibodies (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05163743, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.