ObesityKETOHEARTNCT05781269
Long Term Effect of Very-low-calories Ketogenic Diet on Weight Control and Cardiovascular Brisk Factors (KETOHEART)
A study testing VLCKD and r-MedDiet in people with Obesity and Morbid Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The growing obesity pandemic has a major impact on global cardiovascular (CVD)-related morbidity and premature mortality, severely compromising the quality of life of those affected and significantly increasing costs for the healthcare system. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid Obesity
- What is being tested?
- VLCKD and r-MedDiet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men between the ages of 55 and 75 with no documented history of CVD (except NYHA class I and II heart failure or valvular heart disease)
- Women aged 60 to 75, with no documented history of CVD (except NYHA class I and II heart failure or valvular heart disease)
- BMI ≥30 and <50kg/m2-At least three positive factors for metabolic syndrome according to the harmonized definition (IDF --------2009)
- Availability to be followed in the follow-up at the San Michele Hospital IRCCS Istituto Auxologico Italiano in Milan
Who cannot join
- Long QT >0.44 s, known arrhythmia, cardiomyopathy, heart failure (NYHA classes III-IV)
- Hypokalemia, hypernatremia
- Persistent diarrhea
- Acidosis (metabolic or respiratory) even if compensated
- Acute heart failure, transient ischemic attack or stroke in the previous 12 months
- Pregnancy or breastfeeding
Show all 19Show fewer
- chronic renal insufficiency (creatinine >1.5 and/or creatinine clearance <45 mL/min), history -positive for previous episodes of acute renal failure
- Autoimmune diseases (TCA relative contraindication)
- History of previous pancreatitis
- Symptomatic cholelithiasis
- Hepatic insufficiency and/or ALT and AST > 3 times the upper limit
- Stubborn constipation or history of intestinal occlusions/subocclusions
- Type 1 diabetes
- History of previous cancer within the first 5 years of follow-up
- Active eating disorder or history of bulimia and anorexia nervosa, active severe binge eating,
- Psychiatric disorders not in compensation or at risk of decompensation
- Alcoholism, substance abuse
- Ongoing pharmacological therapy with topiramate, zonisamide, acetazolamide, valproic acid- - ----- - chronic therapy with diuretics (which cannot be suspended even temporarily), SGLT2 -inhibitors (due to the risk of euglycemic diabetic ketoacidosis) and beta blockers.
- Known primary pathologies of carnitine metabolism or beta oxidation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Syndrome and Severe Obesity: Randomized Nutritional Trial to Study Long Term Effect of Very-low-calories Ketogenic Diet (VLCKD) on Weight Control and Cardiovascular Risk Factors
The growing obesity pandemic has a major impact on global cardiovascular (CVD)-related morbidity and premature mortality, severely compromising the quality of life of those affected and significantly increasing costs for the healthcare system.
Numerous scientific evidences have demonstrated that a moderate weight loss (5-10% of the initial body weight) is already sufficient to determine the improvement of the cardiometabolic risk factors associated with overweight and obesity. With a view to obtaining a more significant weight loss in the initial stages of dietary treatment, in the last 10 years, the very low-calorie ketogenic diet (VLCKD) has become a strategy for the treatment of obesity and its comorbidities, also allowing to limit therapeutic failure and the high drop-out typical of traditional low-calorie diets.
Read more
The present study aims to study the long-term efficacy (36 months) of VLCKD in patients with severe obesity and metabolic syndrome, on weight loss, on single factors of the metabolic syndrome compared to a restrictive Mediterranean diet.
One hundred subjects with severe obesity and metabolic syndrome will be recruited and randomly assigned to VLCKD or to restrictive Mediterranean diet. Anthropometric parameters, metabolic status blood pressure, degree of arterial stiffness, prevalence and severity of snoring and OSA, cardiac systolic and diastolic function, the autonomic nervous control mode of the circulation will be evaluated at baseline, after one month and at the end of the study.
Read the detailed description
The present study aims to study the long-term efficacy (36 months) of VLCKD in patients with severe obesity and metabolic syndrome, on weight loss, on single factors of the metabolic syndrome, on the plasma concentration of specific adipokines and myokines on the properties of arterial wall, cardiovascular function, and sleep quantity and quality compared to a restrictive Mediterranean diet.
The studied population includes men and women between the ages of 55 and 75, with no documented history of CVD, severely obese (BMI ≥30 e <50 kg / m2) and at least three positive factors for metabolic syndrome. The patient, after consideration of inclusion and exclusion factors, are enrolled for 36 months and randomly divided into two groups (50 patients for group): group 1 is assigned to VLCKD diet treatment with medical food (VLCKD-group) whereas group 2 followed Mediterranean diet treatment (r-MedDiet). Medical Foods products are provided by Therascience. For both groups, the achievement of the objective is set as a variation of 20% compared to the initial weight. Throughout the study, the long-term efficacy of VLCKD compared with a restrictive Mediterranean diet will be evaluated on the modification of anthropometric parameters (weight, waist circumference, hip circumference, impedance test) metabolic status (using blood chemistry tests for the evaluation of Blood glucose, glycosylated hemoglobin, insulin, total cholesterol, HDL, triglycerides, adiponectin and irisin), blood pressure (by sphygmomanometer), degree of arterial stiffness (by Pulse Wave Velocity carotid-femoral), prevalence and severity of snoring and OSA (by polysomnography), cardiac systolic and diastolic function (by three-dimensional echocardiography), the autonomic nervous control mode of the circulation (by analysis HRV, Arterial Baroreflex Sensitivity). .
These evaluations will be carried out at pre-established and different times (T0-T22) during the entire duration of the study.
The dietary treatment of the r-MedDiet group will provide for an average caloric deficit equal to 1000 kcal of the estimated total daily energy expenditure starting from the basal metabolic rate measured with indirect calorimetry and multiplied by the level of physical activity (LAF) defined on the basis of the Godin questionnaire. The diet will be personalized in 3 or 5 meals/day. Upon reaching the target weight, a Mediterranean-type diet plan will be set with a caloric intake equal to the estimated energy requirement. The VLCKD will be applied with the specific products of the ketogenic protocol supplied by Laboratoire Therascience starting from the Active Phase. During this phase the patients will take 4-6 LIGNAFORM products which will be followed by the Selective Phase in which in one or both of the main meals the LIGNAFORM product will be replaced with a protein dish and the phases of reintroduction of fruit (phase three), dairy products and legumes (phase four), bread and derivatives (phase five) and cereals (phase 6). At the end of the previous phases, a normocaloric maintenance diet will be set, with a carbohydrate intake not exceeding 45% of total daily calories. In these subjects, VLCKD diet will be maintained for 2 weeks every 2 months of maintenance diet.
- Conditions
- Obesity, Morbid Obesity
- Being tested
- VLCKD, r-MedDiet
- Keywords
- VLCKD, obesity, metabolic syndrome, cardiovascular risk
- Medical subject headings
- Obesity, Obesity, Morbid, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLCKDOther
VLCKD diet treatment with medical food
r-MedDietOther
Mediterranean diet treatment
| Study group | Role | What they receive |
|---|---|---|
| VLCKD-group | Experimental | The VLCKD will be applied with the specific products of the ketogenic protocol supplied by Laboratoire Therascience starting from the Active Phase. During this phase the patients will take 4-6 LIGNAFORM products which will be followed by the Selective Phase in which in one or both of the main meals the LIGNAFORM product will be replaced with a protein dish and the phases of reintroduction of fruit (phase three), dairy products and legumes (phase four), bread and derivatives (phase five) and cereals (phase 6). At the end of the previous phases, a normocaloric maintenance diet will be set, with a carbohydrate intake not exceeding 45% of total daily calories. In these subjects, VLCKD diet will be maintained for 2 weeks every 2 months of maintenance diet. Receives: Other: VLCKD |
| r-MedDiet | Experimental | The dietary treatment of the r-MedDiet group will provide for an average caloric deficit equal to 1000 kcal of the estimated total daily energy expenditure starting from the basal metabolic rate measured with indirect calorimetry and multiplied by the level of physical activity (LAF) defined on the basis of the Godin questionnaire. The diet will be personalized in 3 or 5 meals/day. Upon reaching the target weight, a Mediterranean-type diet plan will be set with a caloric intake equal to the estimated energy requirement Receives: Other: r-MedDiet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline body weight at 36 months
body weight measured to the nearest 0.1 Kg with a calibrated weight scale
Measured: baseline, 36 month
change from baseline fasting glucose in mg/dl at 36 months
blood chemistry tests for the evaluation of blood glucose
Measured: baseline, 36 month
change from baseline HDL cholesterol, triglycerides at 36 months
blood chemistry tests for the evaluation of HDL cholesterol, triglycerides
Measured: baseline, 36 month
change from baseline blood pressure in mmHg at 36 months
measurement of systolic and diastolic pressure using using an aneroid sphygmomanometer with the appropriate cuff
Measured: baseline, 36 months
change from baseline distensibility of the carotid, radial and femoral arteries in m/s at 36 months
arterial stiffness measured by Pulse Wave Velocity carotid-femoral
Measured: baseline, 36 months
change from baseline waist circumference in cm at 36 months
waist circumference using a non-stretch tape to the nearest 0.5 cm
Measured: baseline, 36 months
Secondary outcomes (6)
change from baseline total and LDL cholesterol in mg/dl at 36 months
blood chemistry tests for the evaluation of total cholesterol, LDL cholesterol
Measured: baseline, 36 months
change from baseline % of subjects with obstructive sleep apnea at 36 months
apnea hypopnea index using polysomnography
Measured: baseline, 36 months
change from baseline cardiac systolic and diastolic function at 36 months
evaluation of the cardiac systolic and diastolic function using by three-dimensional echocardiography
Measured: baseline, 36 months
change from baseline autonomic nervous control mode of the circulation at 36 months
by analysis HRV, Arterial Baroreflex Sensitivity
Measured: baseline, 36 months
change from baseline insulin in mU/ml at 36 month
blood chemistry tests for the evaluation of insulin
Measured: baseline, 36 months
change from baseline glycated hemoglobin in mmol/mol at 36 month
blood chemistry tests for the evaluation of glycated hemoglobin
Measured: baseline, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start20 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Bertoli, MD, Study chair, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781269
- Sponsor's protocol ID
- 43J001
- Acronym
- KETOHEART
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zomer E, Gurusamy K, Leach R, Trimmer C, Lobstein T, Morris S, James WP, Finer N. Interventions that cause weight loss and the impact on cardiovascular risk factors: a systematic review and meta-analysis. Obes Rev. 2016 Oct;17(10):1001-11. doi: 10.1111/obr.12433. Epub 2016 Jun 21.
PubMed 27324830Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.
PubMed 19878986Look AHEAD Research Group; Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334.
PubMed 20876408Wing RR, Lang W, Wadden TA, Safford M, Knowler WC, Bertoni AG, Hill JO, Brancati FL, Peters A, Wagenknecht L; Look AHEAD Research Group. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6. doi: 10.2337/dc10-2415. Epub 2011 May 18.
PubMed 21593294Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.
PubMed 31111407Esposito K, Kastorini CM, Panagiotakos DB, Giugliano D. Mediterranean diet and weight loss: meta-analysis of randomized controlled trials. Metab Syndr Relat Disord. 2011 Feb;9(1):1-12. doi: 10.1089/met.2010.0031. Epub 2010 Oct 25.
PubMed 20973675
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome and Severe Obesity: Randomized Nutritional Trial to Study Long Term Effect of Very-low-calories Ketogenic Diet (VLCKD) on Weight Control and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT05781269
- Acronym / sponsor ID
- KETOHEART / 43J001
- Conditions
- Obesity, Morbid Obesity
- Keywords
- VLCKD, obesity, metabolic syndrome, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Mar 2023 (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.
The growing obesity pandemic has a major impact on global cardiovascular (CVD)-related morbidity and premature mortality, severely compromising the quality of life of those affected and significantly increasing costs for the healthcare system.
Numerous scientific evidences have demonstrated that a moderate weight loss (5-10% of the initial body weight) is already sufficient to determine the improvement of the cardiometabolic risk factors associated with overweight and obesity. With a view to obtaining a more significant weight loss in the initial stages of dietary treatment, in the last 10 years, the very low-calorie ketogenic diet (VLCKD) has become a strategy for the treatment of obesity and its comorbidities, also allowing to limit therapeutic failure and the high drop-out typical of traditional low-calorie diets.
The present study aims to study the long-term efficacy (36 months) of VLCKD in patients with severe obesity and metabolic syndrome, on weight loss, on single factors of the metabolic syndrome compared to a restrictive Mediterranean diet.
One hundred subjects with severe obesity and metabolic syndrome will be recruited and randomly assigned to VLCKD or to restrictive Mediterranean diet. Anthropometric parameters, metabolic status blood pressure, degree of arterial stiffness, prevalence and severity of snoring and OSA, cardiac systolic and diastolic function, the autonomic nervous control mode of the circulation will be evaluated at baseline, after one month and at the end of the study.
Detailed description
The present study aims to study the long-term efficacy (36 months) of VLCKD in patients with severe obesity and metabolic syndrome, on weight loss, on single factors of the metabolic syndrome, on the plasma concentration of specific adipokines and myokines on the properties of arterial wall, cardiovascular function, and sleep quantity and quality compared to a restrictive Mediterranean diet.
The studied population includes men and women between the ages of 55 and 75, with no documented history of CVD, severely obese (BMI ≥30 e <50 kg / m2) and at least three positive factors for metabolic syndrome. The patient, after consideration of inclusion and exclusion factors, are enrolled for 36 months and randomly divided into two groups (50 patients for group): group 1 is assigned to VLCKD diet treatment with medical food (VLCKD-group) whereas group 2 followed Mediterranean diet treatment (r-MedDiet). Medical Foods products are provided by Therascience. For both groups, the achievement of the objective is set as a variation of 20% compared to the initial weight. Throughout the study, the long-term efficacy of VLCKD compared with a restrictive Mediterranean diet will be evaluated on the modification of anthropometric parameters (weight, waist circumference, hip circumference, impedance test) metabolic status (using blood chemistry tests for the evaluation of Blood glucose, glycosylated hemoglobin, insulin, total cholesterol, HDL, triglycerides, adiponectin and irisin), blood pressure (by sphygmomanometer), degree of arterial stiffness (by Pulse Wave Velocity carotid-femoral), prevalence and severity of snoring and OSA (by polysomnography), cardiac systolic and diastolic function (by three-dimensional echocardiography), the autonomic nervous control mode of the circulation (by analysis HRV, Arterial Baroreflex Sensitivity). .
These evaluations will be carried out at pre-established and different times (T0-T22) during the entire duration of the study.
The dietary treatment of the r-MedDiet group will provide for an average caloric deficit equal to 1000 kcal of the estimated total daily energy expenditure starting from the basal metabolic rate measured with indirect calorimetry and multiplied by the level of physical activity (LAF) defined on the basis of the Godin questionnaire. The diet will be personalized in 3 or 5 meals/day. Upon reaching the target weight, a Mediterranean-type diet plan will be set with a caloric intake equal to the estimated energy requirement. The VLCKD will be applied with the specific products of the ketogenic protocol supplied by Laboratoire Therascience starting from the Active Phase. During this phase the patients will take 4-6 LIGNAFORM products which will be followed by the Selective Phase in which in one or both of the main meals the LIGNAFORM product will be replaced with a protein dish and the phases of reintroduction of fruit (phase three), dairy products and legumes (phase four), bread and derivatives (phase five) and cereals (phase 6). At the end of the previous phases, a normocaloric maintenance diet will be set, with a carbohydrate intake not exceeding 45% of total daily calories. In these subjects, VLCKD diet will be maintained for 2 weeks every 2 months of maintenance diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLCKD-group | Experimental | Other: VLCKDThe VLCKD will be applied with the specific products of the ketogenic protocol supplied by Laboratoire Therascience starting from the Active Phase. During this phase the patients will take 4-6 LIGNAFORM products which will be followed by the Selective Phase in which in one or both of the main meals the LIGNAFORM product will be replaced with a protein dish and the phases of reintroduction of fruit (phase three), dairy products and legumes (phase four), bread and derivatives (phase five) and cereals (phase 6). At the end of the previous phases, a normocaloric maintenance diet will be set, with a carbohydrate intake not exceeding 45% of total daily calories. In these subjects, VLCKD diet will be maintained for 2 weeks every 2 months of maintenance diet. |
| r-MedDiet | Experimental | Other: r-MedDietThe dietary treatment of the r-MedDiet group will provide for an average caloric deficit equal to 1000 kcal of the estimated total daily energy expenditure starting from the basal metabolic rate measured with indirect calorimetry and multiplied by the level of physical activity (LAF) defined on the basis of the Godin questionnaire. The diet will be personalized in 3 or 5 meals/day. Upon reaching the target weight, a Mediterranean-type diet plan will be set with a caloric intake equal to the estimated energy requirement |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men between the ages of 55 and 75 with no documented history of CVD (except NYHA class I and II heart failure or valvular heart disease)
- Women aged 60 to 75, with no documented history of CVD (except NYHA class I and II heart failure or valvular heart disease)
- BMI ≥30 and <50kg/m2-At least three positive factors for metabolic syndrome according to the harmonized definition (IDF --------2009)
- Availability to be followed in the follow-up at the San Michele Hospital IRCCS Istituto Auxologico Italiano in Milan
Key exclusion criteria (19 listed)
- Long QT >0.44 s, known arrhythmia, cardiomyopathy, heart failure (NYHA classes III-IV)
- Hypokalemia, hypernatremia
- Persistent diarrhea
- Acidosis (metabolic or respiratory) even if compensated
- Acute heart failure, transient ischemic attack or stroke in the previous 12 months
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 |
|---|---|---|
| VLCKDVLCKD diet treatment with medical food | Other | VLCKD-group |
| r-MedDietMediterranean diet treatment | Other | r-MedDiet |
Primary outcome
change from baseline body weight at 36 months
Time frame: baseline, 36 month
body weight measured to the nearest 0.1 Kg with a calibrated weight scale
change from baseline fasting glucose in mg/dl at 36 months
Time frame: baseline, 36 month
blood chemistry tests for the evaluation of blood glucose
change from baseline HDL cholesterol, triglycerides at 36 months
Time frame: baseline, 36 month
blood chemistry tests for the evaluation of HDL cholesterol, triglycerides
change from baseline blood pressure in mmHg at 36 months
Time frame: baseline, 36 months
measurement of systolic and diastolic pressure using using an aneroid sphygmomanometer with the appropriate cuff
change from baseline distensibility of the carotid, radial and femoral arteries in m/s at 36 months
Time frame: baseline, 36 months
arterial stiffness measured by Pulse Wave Velocity carotid-femoral
change from baseline waist circumference in cm at 36 months
Time frame: baseline, 36 months
waist circumference using a non-stretch tape to the nearest 0.5 cm
6 secondary outcomes
change from baseline total and LDL cholesterol in mg/dl at 36 months
Time frame: baseline, 36 months
change from baseline % of subjects with obstructive sleep apnea at 36 months
Time frame: baseline, 36 months
change from baseline cardiac systolic and diastolic function at 36 months
Time frame: baseline, 36 months
change from baseline autonomic nervous control mode of the circulation at 36 months
Time frame: baseline, 36 months
change from baseline insulin in mU/ml at 36 month
Time frame: baseline, 36 months
change from baseline glycated hemoglobin in mmol/mol at 36 month
Time frame: baseline, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 27324830Zomer E, Gurusamy K, Leach R, Trimmer C, Lobstein T, Morris S, James WP, Finer N. Interventions that cause weight loss and the impact on cardiovascular risk factors: a systematic review and meta-analysis. Obes Rev. 2016 Oct;17(10):1001-11. doi: 10.1111/obr.12433. Epub 2016 Jun 21.
- Background: PubMed 19878986Diabetes Prevention Program Research Group; Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Epub 2009 Oct 29.
- Background: PubMed 20876408Look AHEAD Research Group; Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334.
- Background: PubMed 21593294Wing RR, Lang W, Wadden TA, Safford M, Knowler WC, Bertoni AG, Hill JO, Brancati FL, Peters A, Wagenknecht L; Look AHEAD Research Group. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6. doi: 10.2337/dc10-2415. Epub 2011 May 18.
- Background: PubMed 31111407Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.
- Background: PubMed 20973675Esposito K, Kastorini CM, Panagiotakos DB, Giugliano D. Mediterranean diet and weight loss: meta-analysis of randomized controlled trials. Metab Syndr Relat Disord. 2011 Feb;9(1):1-12. doi: 10.1089/met.2010.0031. Epub 2010 Oct 25.
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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.
Simona Bertoli, MD study chair
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VLCKD and r-MedDiet in people with Obesity and Morbid Obesity, run by Istituto Auxologico Italiano 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?
The sponsor lists 4 inclusion and 19 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline body weight at 36 months (time frame: baseline, 36 month). The study lists 6 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 NCT05781269, which also lists 6 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 3 Oct 2025.