An interventional study of Usual clinical practice + hypoproteic diet in Acromegaly, sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. Suspended at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita · Not applicable, Interventional, and Treatment
ethical issue
Since protein and AAs are master regulator of GH and IGF-I secretion, we hypothesized that a low protein diet could reduce GH and IGF-I levels in acromegalic patients in addition to conventional therapy. Furthermore, we aim to explore metabolomic, microbiota, and micro-vesicle fingerprints of GH hypersecretion during conventional therapy and after a low protein diet
Nutrients are crucial modifiers of the GH/IGF-I axis. In particular, a close cross-talk between proteins and amino acids (AAs) and GH/IGF-I secretion exists.
Both AAs and proteins affect GH secretion. AAs stimulate GH secretion upon oral administration, with different potency among studies, being the combination of arginine and lysine the most powerful. Soy proteins also stimulate GH secretion when ingested either as hydrolysed proteins or free AAs. Furthermore, the acute GH response to AAs ingestion may be influenced by the daily amount of dietary protein/AAs consumption: diets high in proteins apparently increase basal GH levels.
AAs and proteins have a positive effect on IGF-I secretion as well. In general, high levels of proteins, especially animal and dairy proteins, and consumption of branched chain amino acids (BCAAs) increase serum IGF-I levels.
Considering pathological GH conditions, metabolomic analysis of acromegalic patients suggests that the main metabolic fingerprint of GH hypersecretion is a reduction in BCAAs, related to the disease activity. Moreover, there is evidence that GH, rather than IGF-I, is the main mediator of such metabolic fingerprint, which may be related to increased uptake of BCAAs by the muscles, increased gluconeogenesis, and raised consumption of BCAAs.
Thus, in acromegaly, a tailored diet is a further strategy that may contribute to blunt GH/IGF-I secretion. Indeed, some authors recently suggested that "personalized" or "precision" nutrition in some conditions and diseases could have an impact on their phenotype, combining dietary recommendations with individual's genetic makeup, metabolic and microbiome characteristics, and environment. However, studies on precision nutrition in acromegaly are still in a neonatal era.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's planned enrollment of 12 is below the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →Azienda Ospedaliero Universitaria Maggiore della Carita is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Patients will continue the usual medical outpatient visits cadency and will keep the same pharmacological therapy throughout the whole duration of the study. Drugs have to include somatostatin analogues. At the same time, patients will be trained by an expert dietician in the habit of an isocaloric and hypoproteic diet and will come back at 2,4,6 and 8 weeks after T0 for all the necessary study assessments and compliance checking.
Other: Usual clinical practice + hypoproteic diet
Diet will be composed by: * energy equal to daily energy expenditure (estimated by indirect calorimetry \* physical activity factor) * fats 28-35% * carbohydrates 50-60% * proteins 0,7-0,8g/kg of body weight 10-13% Diet will be given to the patient after the first visit and the study will start once the patient begins the diet.
Change in disease related hormones
Variation of GH, IGF-1, IGFBP1, IGFBP3 hormones
Time frame: Change from Baseline GH, IGF-1, IGFBP1, IGFBP3 blood levels at 15 days, 30 days, 45 days, 60 days
Change in weight
Variation of body weight assessed through body mass index change (BMI)(kg/m2)
Time frame: Change from Baseline BMI at 15 days, 30 days, 45 days, 60 days
Change in body circumferences
Variation of body circumferences (waist, hips)
Time frame: Change from Baseline circumferences at 15 days, 30 days, 45 dyas, 60 days
Change in metabolic control
Change of cardio-metabolic risk factors: lipid profile
Time frame: Change from Baseline lipid profile at 15 days, 30 days, 45 days, 60 days
Change in metabolic control
Change of cardio-metabolic risk factors: insulin resistance (HOMA-IR)
Time frame: Change from Baseline lipid profile at 60 days
Change in kidney profile
Variation of serum creatinin
Time frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Change in liver profile
Variation of liver markers(AST, ALT, GGT)
Time frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Change in uric acid
Variation of uric acid in blood through enzymatic determination
Time frame: Change from Baseline uric acid in blood at 15 days, 30 days, 45 days, 60 days
Change in body composition
Change of body composition (fat mass %) (BIVA)
Time frame: Change from Baseline fat mass% at 60 days
Change in body composition
Change of body composition (fat mass %) (DXA)
Time frame: Change from Baseline fat mass% at 60 days
Change in blood count
Variation of blood count
Time frame: Change from Baseline blood count at 15 days, 30 days, 45 days, 60 days
Change in microbiota
Variation of prevalence of microbiota phyla through DNA sequencing of stools
Time frame: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 45 days, 60 days
Change in omics profile
Variation of lipidomic profile of stools through liquid and gas chromatography
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Change in omics profile
Variation of proteomic profile of stools through liquid and gas chromatography
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Change in microvesicles
Variation of urinary microvesicles levels
Time frame: Change from Baseline microvesicles levels at 15, 30 days, 45 days, 60 days
Change in microvesicles
Variation of serum microvesicles levels
Time frame: Change from Baseline microvesicles levels s at 15, 30 days, 45 days, 60 days
Change in basal metabolic rate
Variation of basal metabolic rate (kcal)
Time frame: Change from Baseline basal metabolic rate at 60 days
Plan to share: Undecided
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: start Sep 2024 → Dec 2026, primary completion Dec 2025 → Dec 2028 and completion Mar 2026 → Mar 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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ethical issue
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero Universitaria Maggiore della Carita