ObesityKEMESONCT05898204
KEtogenic Diet and Its Multiple EffectS on Obesity
A study testing Ketogenic diet and Balanced diet in people with Obesity, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The prevalence of obesity and metabolic disturbances is worryingly increasing worldwide, therefore the study of their pathophysiology is extremely important to find new strategies for their treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Ketogenic diet and Balanced diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2022to 23 Jun 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- BMI≥ 30 Kg/m2
Who cannot join
- Type 1 diabetes mellitus and latent autoimmune diabetes in adults
- β-cell failure in type 2 diabetes mellitus
- Use of sodium/glucose cotransporter 2 (SGLT2) inhibitors
- Pregnancy and breastfeeding
- Kidney failure and moderate-to-severe chronic kidney disease
- Liver failure
Show all 14Show fewer
- Heart failure (NYHA III-IV)
- Respiratory failure
- Unstable angina, stroke or myocardial infarction in the last 12 months
- Cardiac arrhythmias
- Eating disorders and other severe mental illnesses, alcohol and substance abuse
- Active/severe infections
- Planned elective surgery or invasive procedures
- Rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial
The prevalence of obesity and metabolic disturbances is worryingly increasing worldwide, therefore the study of their pathophysiology is extremely important to find new strategies for their treatment. Obesity has a strong impact not only on the metabolism of the patients, but also may impact hormonal, inflammatory and immune profile, and profoundly influence the daily life of the patients. Weight loss may determine an amelioration of these parameters, but the impact of the diet composition aimed to weight loss on them has not been profoundly studied yet.
The aim of our research project is to study the effects of a ketogenic diet in comparison with an isocaloric balanced diet on weight loss and anthropometric parameters, quality of life, hormone profile, sleep, sexual function, circadian rhythm, inflammatory and immunological parameters in obese patients.
- Conditions
- Obesity
- Being tested
- Ketogenic diet, Balanced diet
- Keywords
- obesity, metabolism, circadian rhythm, sleep, quality of life, balanced diet, ketogenic diet, immune profile
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.
Balanced dietOther
Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet arm | Experimental | Ketogenic diet for a month, or a longer period if clinically necessary Receives: Other: Ketogenic diet |
| Balanced diet arm | Active comparator | Balanced diet for a month, or a longer period if clinically necessary Receives: Other: Balanced diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires
Assessment with the questionnaires Impact of weight/Quality of Life-Lite (IWQOL-Lite); global scale from 0 to 100; the higher the score, the better the quality of life
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
Assessment with the questionnaires Short Form Health Survey 36 (SF-36); scale of every item from 0 to 100; the higher the score, the better the quality of life
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires
Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary outcomes (20)
Evaluation of weight loss
Weight loss expressed in Kg
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of perceived sleep
Assessment with the questionnaires Pittsburgh Sleep Quality Index; global score on a scale from 0 to 21; the higher the score, the worse the sleep quality
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of perceived sleepiness
Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in clock genes expression
Evaluation of the expression of the clock genes in blood cells
Measured: At baseline, at 30 days
Evaluation of changes in hormonal profile
Assessment of hormonal parameters, as cortisol, expressed in ug/dL
Measured: At baseline, at 30 days
Evaluation of changes in sexual function in males
Assessed with the questionnaires International Index of Erectile Function (IIEF-5); scale from 5 to 25; the higher the score, the better the erectile function
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in inflammation
Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL
Measured: At baseline, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of peripheral blood mononuclear cells
Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3
Measured: At baseline, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in sleep parameters (length)
Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes
Measured: At baseline, at 30 days
Evaluation of changes in hip circumference
Assessment of hip circumference, expressed in cm
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in waist circumference
Assessment of waist circumference, expressed in cm
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Change in circadian rhythm
Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours
Measured: At baseline, at 30 days
Evaluation of changes in Sexual Function in Females
Assessed with the questionnaire Female Sexual Function Index (FSFI); scale of every item from 1 to 5; the higher score, the better the sexual function
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in sleep efficiency
Sleep efficiency expressed as a percentage; measurement with actigraphy
Measured: At baseline, at 30 days
Evaluation of changes in number of awakenings
Measurement with actigraphy
Measured: At baseline, at 30 days
Evaluation of changes in sleep parameters
Evaluation of sleep fragmentation index and movement index, with actigraphy
Measured: At baseline, at 30 days
Evaluation of changes in metabolic parameters
Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L
Measured: At baseline, at 30 days
Evaluation of changes in BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of height
Assessment of height, expressed in cm
Measured: At baseline
Evaluation of changes in whole blood cells gene expression
Evaluation of the changes in the expression of blood cells genes, as metabolic, inflammatory and immunological genes, with RNA-seq in whole blood cells
Measured: At baseline, at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start3 Feb 2022
- Primary completion6 May 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Model description
- Patients are sequentially allocated to one of the 2 arms of intervention: the ketogenic diet arm or the balanced diet arm.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898204
- Sponsor's protocol ID
- KEMESO1
- Acronym
- KEMESO
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05898204
- Acronym / sponsor ID
- KEMESO / KEMESO1
- Conditions
- Obesity
- Keywords
- obesity, metabolism, circadian rhythm, sleep, quality of life, balanced diet, ketogenic diet, immune profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 12 Jun 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 prevalence of obesity and metabolic disturbances is worryingly increasing worldwide, therefore the study of their pathophysiology is extremely important to find new strategies for their treatment. Obesity has a strong impact not only on the metabolism of the patients, but also may impact hormonal, inflammatory and immune profile, and profoundly influence the daily life of the patients. Weight loss may determine an amelioration of these parameters, but the impact of the diet composition aimed to weight loss on them has not been profoundly studied yet.
The aim of our research project is to study the effects of a ketogenic diet in comparison with an isocaloric balanced diet on weight loss and anthropometric parameters, quality of life, hormone profile, sleep, sexual function, circadian rhythm, inflammatory and immunological parameters in obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are sequentially allocated to one of the 2 arms of intervention: the ketogenic diet arm or the balanced diet arm.
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet arm | Experimental | Other: Ketogenic dietKetogenic diet for a month, or a longer period if clinically necessary |
| Balanced diet arm | Active comparator | Other: Balanced dietBalanced diet for a month, or a longer period if clinically necessary |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 65 years
- BMI≥ 30 Kg/m2
Key exclusion criteria (14 listed)
- Type 1 diabetes mellitus and latent autoimmune diabetes in adults
- β-cell failure in type 2 diabetes mellitus
- Use of sodium/glucose cotransporter 2 (SGLT2) inhibitors
- Pregnancy and breastfeeding
- Kidney failure and moderate-to-severe chronic kidney disease
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 |
|---|---|---|
| Ketogenic dietPrescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day. | Other | Ketogenic diet arm |
| Balanced dietPrescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day. | Other | Balanced diet arm |
Primary outcome
Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment with the questionnaires Impact of weight/Quality of Life-Lite (IWQOL-Lite); global scale from 0 to 100; the higher the score, the better the quality of life
Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment with the questionnaires Short Form Health Survey 36 (SF-36); scale of every item from 0 to 100; the higher the score, the better the quality of life
Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem
20 secondary outcomes
Evaluation of weight loss
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of perceived sleep
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of perceived sleepiness
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in clock genes expression
Time frame: At baseline, at 30 days
Evaluation of changes in hormonal profile
Time frame: At baseline, at 30 days
Evaluation of changes in sexual function in males
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in inflammation
Time frame: At baseline, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of peripheral blood mononuclear cells
Time frame: At baseline, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in sleep parameters (length)
Time frame: At baseline, at 30 days
Evaluation of changes in hip circumference
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in waist circumference
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Change in circadian rhythm
Time frame: At baseline, at 30 days
Evaluation of changes in Sexual Function in Females
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in sleep efficiency
Time frame: At baseline, at 30 days
Evaluation of changes in number of awakenings
Time frame: At baseline, at 30 days
Evaluation of changes in sleep parameters
Time frame: At baseline, at 30 days
Evaluation of changes in metabolic parameters
Time frame: At baseline, at 30 days
Evaluation of changes in BMI
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of height
Time frame: At baseline
Evaluation of changes in whole blood cells gene expression
Time frame: At baseline, at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet and Balanced 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?
The sponsor lists 2 inclusion and 14 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: finished, as of the sponsor's last update on 14 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires (time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.