AcromegalyNCT07100587
Ketogenic vs. Mediterranean Diet on Metabolic and Hormonal Parameters in Patients With Active Acromegaly
A study testing Ketogenic diet and Mediterranean diet in people with Acromegaly, run by University of Palermo at 1 site in Italy.
Trial summary
This prospective, single-center, crossover study aims to evaluate the metabolic and hormonal effects of a ketogenic diet compared to a Mediterranean diet in patients with active acromegaly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Ketogenic diet and Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2024to 2 Jul 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Confirmed diagnosis of active acromegaly (elevated IGF-1, GH non-suppressible at OGTT)
- Stable medical therapy for ≥ 3 months
- BMI 25-40 kg/m²
- Informed consent signed
Who cannot join
- Type 1 diabetes or insulin-treated type 2 diabetes mellitus
- History of ketoacidosis
- Active malignancy, decompensated liver/kidney disease
- Severe psychiatric disorders or eating disorders
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Ketogenic vs. Mediterranean Diet on Metabolic and Hormonal Parameters in Patients With Active Acromegaly: A Prospective Crossover Study
This prospective, single-center, crossover study aims to evaluate the metabolic and hormonal effects of a ketogenic diet compared to a Mediterranean diet in patients with active acromegaly. Twenty-six adult patients with biochemically confirmed active acromegaly will undergo a three-week ketogenic diet followed by a three-week Mediterranean diet, with a two-week transitional phase. The primary outcome is the change in serum IGF-1 levels. Secondary outcomes include changes in anthropometric, biochemical, and inflammatory parameters. The study also explores the feasibility and safety of a structured ketogenic dietary intervention in this population.
Read the detailed description
Acromegaly is a rare endocrine disorder characterized by excessive secretion of growth hormone (GH) and insulin-like growth factor 1 (IGF-1), often leading to metabolic complications including insulin resistance, diabetes mellitus, and hepatic steatosis. Nutritional status is a key regulator of the somatotropic axis, and recent evidence suggests that specific dietary patterns can modulate GH and IGF-1 secretion. The ketogenic diet (KD), characterized by high fat, moderate protein, and very low carbohydrate intake, induces nutritional ketosis, improves insulin sensitivity, and reduces circulating insulin levels. These effects may influence the hepatic expression of GH receptors and IGF-1 production. Preliminary data suggest that KD may reduce IGF-1 levels in patients with acromegaly.
This study is designed as a single-arm crossover trial involving 26 patients with active acromegaly. All participants will follow a structured ketogenic diet for three weeks (~1200 kcal/day, carbohydrates <30 g/day), followed by a two-week transition phase, and then a Mediterranean diet for three weeks (~1200 kcal/day, plant-based, rich in olive oil and fish). Baseline, post-KD, and post-Mediterranean assessments will include serum IGF-1 and GH levels, anthropometric measurements, body composition (via bioelectrical impedance analysis), liver enzymes, lipid profile, insulin resistance indices (HOMA-IR), and inflammatory markers (c-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio).
The primary endpoint is the within-subject change in serum IGF-1 concentration. Secondary endpoints include changes in metabolic and inflammatory markers. Antidiabetic medications will be temporarily discontinued during the ketogenic phase under clinical supervision in patients not requiring insulin. The study is expected to provide novel insights into the impact of dietary modulation on the somatotropic axis in acromegaly and may inform future integrative therapeutic strategies.
- Conditions
- Acromegaly
- Being tested
- Ketogenic diet, Mediterranean diet
- Keywords
- ketogenic diet, mediterranean diet
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietBehavioural
A structured, equicaloric ketogenic diet providing approximately 1200 kcal/day, consisting of high fat (70-80 g/day), moderate protein (80-90 g/day), and very low carbohydrate intake (20-30 g/day), primarily from non-starchy vegetables. The diet is administered for 3 consecutive weeks to induce nutritional ketosis. A sugar-free multivitamin supplement is provided throughout the intervention.
Mediterranean dietBehavioural
A structured Mediterranean diet administered for 3 weeks following a 2-week transition phase. The diet provides approximately 1200 kcal/day and emphasizes plant-based foods, extra virgin olive oil as the main fat source, moderate consumption of fish, dairy products, and whole grains, with limited red meat and processed foods.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Ketogenic Diet (3 weeks) | Experimental | Participants will follow a structured ketogenic diet for 3 weeks (~1200 kcal/day, <30 g/day carbohydrates) to induce nutritional ketosis. Receives: Behavioral: Ketogenic diet |
| Arm B: Mediterranean Diet | Active comparator | Following a 2-week transition phase, participants will switch to a Mediterranean diet for 3 weeks (~1200 kcal/day), rich in olive oil, vegetables, whole grains, and moderate protein intake. Receives: Behavioral: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control
Change in serum IGF-1 levels after ketogenic and Mediterranean diets (paired comparison)
Measured: 3 weeks
Secondary outcomes (8)
Metabolic outcomes
Change in fasting glucose (mg/dL)
Measured: 3 weeks
Metabolic outcomes
Change in fasting insulin (µU/mL)
Measured: 3 weeks
Metabolic outcomes
Change in HOMA-IR (unitless)
Measured: 3 weeks
Anthropometric outcomes
Change in body weight (kg)
Measured: 3 weeks
Anthropometric outcomes
Change in Body Mass Index (BMI) (kg/m²)
Measured: 3 weeks
Anthropometric outcomes
Change in waist circumference (cm)
Measured: 3 weeks
Liver outcomes
Change in transaminases (U/L)
Measured: 3 weeks
Lean and fat masses
Change in lean and fat mass (only after ketogenic diet)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start30 Jun 2024
- Primary completion31 May 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Guarnotta, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100587
- Sponsor's protocol ID
- 14
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This decision is based on institutional policy and ethical considerations, as the study involves a relatively small and identifiable patient population with a rare endocrine disorder. Data sharing may compromise patient confidentiality despite de-identification procedures.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Ketogenic vs. Mediterranean Diet on Metabolic and Hormonal Parameters in Patients With Active Acromegaly: A Prospective Crossover Study
- ClinicalTrials.gov ID
- NCT07100587
- Acronym / sponsor ID
- 14
- Conditions
- Acromegaly
- Keywords
- ketogenic diet, mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 3 Aug 2025 (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.
This prospective, single-center, crossover study aims to evaluate the metabolic and hormonal effects of a ketogenic diet compared to a Mediterranean diet in patients with active acromegaly. Twenty-six adult patients with biochemically confirmed active acromegaly will undergo a three-week ketogenic diet followed by a three-week Mediterranean diet, with a two-week transitional phase. The primary outcome is the change in serum IGF-1 levels. Secondary outcomes include changes in anthropometric, biochemical, and inflammatory parameters. The study also explores the feasibility and safety of a structured ketogenic dietary intervention in this population.
Detailed description
Acromegaly is a rare endocrine disorder characterized by excessive secretion of growth hormone (GH) and insulin-like growth factor 1 (IGF-1), often leading to metabolic complications including insulin resistance, diabetes mellitus, and hepatic steatosis. Nutritional status is a key regulator of the somatotropic axis, and recent evidence suggests that specific dietary patterns can modulate GH and IGF-1 secretion. The ketogenic diet (KD), characterized by high fat, moderate protein, and very low carbohydrate intake, induces nutritional ketosis, improves insulin sensitivity, and reduces circulating insulin levels. These effects may influence the hepatic expression of GH receptors and IGF-1 production. Preliminary data suggest that KD may reduce IGF-1 levels in patients with acromegaly.
This study is designed as a single-arm crossover trial involving 26 patients with active acromegaly. All participants will follow a structured ketogenic diet for three weeks (~1200 kcal/day, carbohydrates <30 g/day), followed by a two-week transition phase, and then a Mediterranean diet for three weeks (~1200 kcal/day, plant-based, rich in olive oil and fish). Baseline, post-KD, and post-Mediterranean assessments will include serum IGF-1 and GH levels, anthropometric measurements, body composition (via bioelectrical impedance analysis), liver enzymes, lipid profile, insulin resistance indices (HOMA-IR), and inflammatory markers (c-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio).
The primary endpoint is the within-subject change in serum IGF-1 concentration. Secondary endpoints include changes in metabolic and inflammatory markers. Antidiabetic medications will be temporarily discontinued during the ketogenic phase under clinical supervision in patients not requiring insulin. The study is expected to provide novel insights into the impact of dietary modulation on the somatotropic axis in acromegaly and may inform future integrative therapeutic strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Ketogenic Diet (3 weeks) | Experimental | Behavioral: Ketogenic dietParticipants will follow a structured ketogenic diet for 3 weeks (~1200 kcal/day, <30 g/day carbohydrates) to induce nutritional ketosis. |
| Arm B: Mediterranean Diet | Active comparator | Behavioral: Mediterranean dietFollowing a 2-week transition phase, participants will switch to a Mediterranean diet for 3 weeks (~1200 kcal/day), rich in olive oil, vegetables, whole grains, and moderate protein intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Confirmed diagnosis of active acromegaly (elevated IGF-1, GH non-suppressible at OGTT)
- Stable medical therapy for ≥ 3 months
- BMI 25-40 kg/m²
- Informed consent signed
Key exclusion criteria (5 listed)
- Type 1 diabetes or insulin-treated type 2 diabetes mellitus
- History of ketoacidosis
- Active malignancy, decompensated liver/kidney disease
- Severe psychiatric disorders or eating disorders
- Pregnancy or breastfeeding
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 dietA structured, equicaloric ketogenic diet providing approximately 1200 kcal/day, consisting of high fat (70-80 g/day), moderate protein (80-90 g/day), and very low carbohydrate intake (20-30 g/day), primarily from non-starchy vegetables. The diet is administered for 3 consecutive weeks to induce nutritional ketosis. A sugar-free multivitamin supplement is provided throughout the intervention. | Behavioural | Arm A - Ketogenic Diet (3 weeks) |
| Mediterranean dietA structured Mediterranean diet administered for 3 weeks following a 2-week transition phase. The diet provides approximately 1200 kcal/day and emphasizes plant-based foods, extra virgin olive oil as the main fat source, moderate consumption of fish, dairy products, and whole grains, with limited red meat and processed foods. | Behavioural | Arm B: Mediterranean Diet |
Primary outcome
Disease control
Time frame: 3 weeks
Change in serum IGF-1 levels after ketogenic and Mediterranean diets (paired comparison)
8 secondary outcomes
Metabolic outcomes
Time frame: 3 weeks
Metabolic outcomes
Time frame: 3 weeks
Metabolic outcomes
Time frame: 3 weeks
Anthropometric outcomes
Time frame: 3 weeks
Anthropometric outcomes
Time frame: 3 weeks
Anthropometric outcomes
Time frame: 3 weeks
Liver outcomes
Time frame: 3 weeks
Lean and fat masses
Time frame: 3 weeks
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 5 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This decision is based on institutional policy and ethical considerations, as the study involves a relatively small and identifiable patient population with a rare endocrine disorder. Data sharing may compromise patient confidentiality despite de-identification procedures.
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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 Mediterranean diet in people with Acromegaly, run by University of Palermo 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 5 inclusion and 5 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 5 Sep 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?
Disease control (time frame: 3 weeks). 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 5 Sep 2025.