FibromyalgiaKD-FM-OANCT05848544
Efficacy of a Very Low Calories Ketogenic Diet in Obese Patients With Fibromyalgia or Symptomatic Knee Osteoarthritis
A study testing Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis and Very low-calorie ketogenic diet for patients with fibromyalgia in people with Fibromyalgia and Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Adult patients with fibromyalgia or symptomatic knee osteoarthritis and comorbid obesity eligible to a very low calories ketogenic diet will be enrolled in the pilot study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Knee Osteoarthritis
- What is being tested?
- Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis and Very low-calorie ketogenic diet for patients with fibromyalgia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2021to 31 Dec 2024
- 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 > 18 years and < 65 years
- Body mass index ≥ 30 kg/m2
- Failed to achieve weight loss with standard low-calories diet
- Any of the following conditions:
- BMI ≥ 35 kg/m2 Past diagnosis of type 2 diabetes without β-cell failure Hypertriglyceridemia (fasting triglycerides ≥ 150 mg/dL) or taking lipid-lowering medications Hypercholesterolemia (total cholesterol > 200 mg/dL) or taking lipid-lowering medications Past diagnosis of arterial hypertension or taking blood pressure-lowering medications Past diagnosis of non-alcoholic fatty liver disease Past diagnosis of heart failure class NYHA I-II Past history of myocardial infarction (> 12 months), stroke/minor stroke (> 12 months) Past diagnosis of carotid atherosclerosis Past diagnosis of polycystic ovary syndrome (PCOS) Past diagnosis of neurodegenerative disorders
- Fibromyalgia classified according to 2016 Revisions to the 2010/2011 European League Against Rheumatism/ American College of Rheumatology OR
- Symptomatic knee osteoarthritis
Who cannot join
- Age < 18 or > 65 years
- Currently pregnant or breastfeeding
- Past diagnosis of type 1 diabetes mellitus, latent autoimmune diabetes in adults, β-cell failure in type 2 diabetes mellitus, use of sodium/glucose cotransporter 2 inhibitors (risk for euglycemic diabetic ketoacidosis)
- Past diagnosis of kidney failure and moderate-to-severe chronic kidney disease, liver failure, hearth failure NYHA III-IV, respiratory failure
- Past diagnosis of unstable angina
- Recent stroke or myocardial infarction (< 12 months)
Show all 13Show fewer
- Cardiac arrhythmias
- Past diagnosis of eating disorders and other severe mental illnesses, alcohol and substance abuse
- Active/severe infections
- 48 h prior to elective surgery or invasive procedures and perioperative period
- Past diagnosis of rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency
- Allergy to protein-preparations ingredients
- Past or current history of gallstones
Trial locations and contacts
1 site in 1 country.
About this study
Adult patients with fibromyalgia or symptomatic knee osteoarthritis and comorbid obesity eligible to a very low calories ketogenic diet will be enrolled in the pilot study
Read the detailed description
the study will be conducted following different periods:
- Free diet (for 4 weeks). After recruitment, the patient will enter "free diet phase" in which he/she will be asked to follow a normal free diet for 4 weeks. During this period, a nutritional interview will be carried out by a trained dietician who will elaborate a personalized diet and order the ketogenic products on the basis of patient's preferences.
- very low calories ketogenic diet (for 8 weeks). After the free diet period, the patient will start the very low calories ketogenic regimen. At the beginning of this period a box with the commercial products necessary to cover the whole study period will be hand-delivered by a dietician that will instruct the patient on the correct use and storage.
- Maintenance (for 12 weeks). After very low calories ketogenic diet phase, the patient will start maintenance period as described
- Conditions
- Fibromyalgia, Knee Osteoarthritis
- Being tested
- Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis, Very low-calorie ketogenic diet for patients with fibromyalgia
- Medical subject headings
- Fibromyalgia, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritisDietary supplement
A personalized very low-calorie ketogenic diet will be prepared for each patient by specialized dietitians using a combination of commercially-available ketogenic preparations and patient's handmade prepared meals
Very low-calorie ketogenic diet for patients with fibromyalgiaDietary supplement
A personalized very low-calorie ketogenic diet will be prepared for each patient by specialized dietitians using a combination of commercially-available ketogenic preparations and patient's handmade prepared meals
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic knee osteoarthritis | Other | obese patients with symptomatic knee osteoarthritis eligible to a very low calories ketogenic diet Receives: Dietary Supplement: Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis |
| obese patients with fibromyalgia | Other | obese patients with with fibromyalgia eligible to a very low calories ketogenic diet Receives: Dietary Supplement: Very low-calorie ketogenic diet for patients with fibromyalgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of the very low-calorie ketogenic diet in patient with fibromyalgia
change in Fibromyalgia Impact Questionnaire total score for fibromyalgia
Measured: baseline, 8 weeks and 20 weeks
efficacy of the very low-calorie ketogenic diet in patient with osteoarthritis
change in Western Ontario total score for osteoarthritis
Measured: baseline, 8 weeks and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start2 Apr 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848544
- Sponsor's protocol ID
- KD-FM-OA
- Acronym
- KD-FM-OA
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ciaffi J, Mancarella L, Pederzani G, Lisi L, Brusi V, Pignatti F, Ricci S, Vitali G, Faldini C, Ursini F. Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study. Nutrients. 2024 Sep 24;16(19):3236. doi: 10.3390/nu16193236.
PubMed 39408203Ciaffi J, Lisi L, Mari A, Mancarella L, Brusi V, Pignatti F, Ricci S, Vitali G, Stefanelli N, Assirelli E, Neri S, Naldi S, Faldini C, Ursini F. Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study. Front Nutr. 2023 Jul 12;10:1219321. doi: 10.3389/fnut.2023.1219321. eCollection 2023.
PubMed 37502721
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Very Low Calories Ketogenic Diet in Obese Patients With Fibromyalgia or Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05848544
- Acronym / sponsor ID
- KD-FM-OA / KD-FM-OA
- Conditions
- Fibromyalgia, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 May 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.
Adult patients with fibromyalgia or symptomatic knee osteoarthritis and comorbid obesity eligible to a very low calories ketogenic diet will be enrolled in the pilot study
Detailed description
the study will be conducted following different periods:
- Free diet (for 4 weeks). After recruitment, the patient will enter "free diet phase" in which he/she will be asked to follow a normal free diet for 4 weeks. During this period, a nutritional interview will be carried out by a trained dietician who will elaborate a personalized diet and order the ketogenic products on the basis of patient's preferences.
- very low calories ketogenic diet (for 8 weeks). After the free diet period, the patient will start the very low calories ketogenic regimen. At the beginning of this period a box with the commercial products necessary to cover the whole study period will be hand-delivered by a dietician that will instruct the patient on the correct use and storage.
- Maintenance (for 12 weeks). After very low calories ketogenic diet phase, the patient will start maintenance period as described
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic knee osteoarthritis | Other | Dietary Supplement: Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritisobese patients with symptomatic knee osteoarthritis eligible to a very low calories ketogenic diet |
| obese patients with fibromyalgia | Other | Dietary Supplement: Very low-calorie ketogenic diet for patients with fibromyalgiaobese patients with with fibromyalgia eligible to a very low calories ketogenic diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years and < 65 years
- Body mass index ≥ 30 kg/m2
- Failed to achieve weight loss with standard low-calories diet
- Any of the following conditions:
- BMI ≥ 35 kg/m2 Past diagnosis of type 2 diabetes without β-cell failure Hypertriglyceridemia (fasting triglycerides ≥ 150 mg/dL) or taking lipid-lowering medications Hypercholesterolemia (total cholesterol > 200 mg/dL) or taking lipid-lowering medications Past diagnosis of arterial hypertension or taking blood pressure-lowering medications Past diagnosis of non-alcoholic fatty liver disease Past diagnosis of heart failure class NYHA I-II Past history of myocardial infarction (> 12 months), stroke/minor stroke (> 12 months) Past diagnosis of carotid atherosclerosis Past diagnosis of polycystic ovary syndrome (PCOS) Past diagnosis of neurodegenerative disorders
Key exclusion criteria (13 listed)
- Age < 18 or > 65 years
- Currently pregnant or breastfeeding
- Past diagnosis of type 1 diabetes mellitus, latent autoimmune diabetes in adults, β-cell failure in type 2 diabetes mellitus, use of sodium/glucose cotransporter 2 inhibitors (risk for euglycemic diabetic ketoacidosis)
- Past diagnosis of kidney failure and moderate-to-severe chronic kidney disease, liver failure, hearth failure NYHA III-IV, respiratory failure
- Past diagnosis of unstable angina
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 |
|---|---|---|
| Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritisA personalized very low-calorie ketogenic diet will be prepared for each patient by specialized dietitians using a combination of commercially-available ketogenic preparations and patient's handmade prepared meals | Dietary supplement | Symptomatic knee osteoarthritis |
| Very low-calorie ketogenic diet for patients with fibromyalgiaA personalized very low-calorie ketogenic diet will be prepared for each patient by specialized dietitians using a combination of commercially-available ketogenic preparations and patient's handmade prepared meals | Dietary supplement | obese patients with fibromyalgia |
Primary outcome
efficacy of the very low-calorie ketogenic diet in patient with fibromyalgia
Time frame: baseline, 8 weeks and 20 weeks
change in Fibromyalgia Impact Questionnaire total score for fibromyalgia
efficacy of the very low-calorie ketogenic diet in patient with osteoarthritis
Time frame: baseline, 8 weeks and 20 weeks
change in Western Ontario total score for osteoarthritis
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 26 Mar 2025.
- Derived from this study: PubMed 39408203Ciaffi J, Mancarella L, Pederzani G, Lisi L, Brusi V, Pignatti F, Ricci S, Vitali G, Faldini C, Ursini F. Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study. Nutrients. 2024 Sep 24;16(19):3236. doi: 10.3390/nu16193236.
- Derived from this study: PubMed 37502721Ciaffi J, Lisi L, Mari A, Mancarella L, Brusi V, Pignatti F, Ricci S, Vitali G, Stefanelli N, Assirelli E, Neri S, Naldi S, Faldini C, Ursini F. Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study. Front Nutr. 2023 Jul 12;10:1219321. doi: 10.3389/fnut.2023.1219321. eCollection 2023.
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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 Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis and Very low-calorie ketogenic diet for patients with fibromyalgia in people with Fibromyalgia and Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli 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 7 inclusion and 13 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 26 Mar 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?
efficacy of the very low-calorie ketogenic diet in patient with fibromyalgia (time frame: baseline, 8 weeks and 20 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 NCT05848544, which also lists 2 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 26 Mar 2025.