Hypoproteic Diet in Acromegaly (IpoProAcro)

September 27, 2023 updated by: Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita

Deciphering the Role of a Low Protein Diet in Disease Control in Acromegalic Patients

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18/65
  • Diagnosis of Acromegaly
  • In therapy with somatostatin analogues

Exclusion Criteria:

  • pregnancy or lactation
  • alchool or drugs abuse
  • cancer
  • Hematological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acromegalic adult in therapy with somatostatin analogues
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in disease related hormones
Time Frame: Change from Baseline GH, IGF-1, IGFBP1, IGFBP3 blood levels at 15 days, 30 days, 45 days, 60 days
Variation of GH, IGF-1, IGFBP1, IGFBP3 hormones
Change from Baseline GH, IGF-1, IGFBP1, IGFBP3 blood levels at 15 days, 30 days, 45 days, 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: Change from Baseline BMI at 15 days, 30 days, 45 days, 60 days
Variation of body weight assessed through body mass index change (BMI)(kg/m2)
Change from Baseline BMI at 15 days, 30 days, 45 days, 60 days
Change in body circumferences
Time Frame: Change from Baseline circumferences at 15 days, 30 days, 45 dyas, 60 days
Variation of body circumferences (waist, hips)
Change from Baseline circumferences at 15 days, 30 days, 45 dyas, 60 days
Change in metabolic control
Time Frame: Change from Baseline lipid profile at 15 days, 30 days, 45 days, 60 days
Change of cardio-metabolic risk factors: lipid profile
Change from Baseline lipid profile at 15 days, 30 days, 45 days, 60 days
Change in metabolic control
Time Frame: Change from Baseline lipid profile at 60 days
Change of cardio-metabolic risk factors: insulin resistance (HOMA-IR)
Change from Baseline lipid profile at 60 days
Change in kidney profile
Time Frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Variation of serum creatinin
Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Change in liver profile
Time Frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Variation of liver markers(AST, ALT, GGT)
Change from Baseline Serum Creatinin at 15 days, 30 days, 45 days, 60 days
Change in uric acid
Time Frame: Change from Baseline uric acid in blood at 15 days, 30 days, 45 days, 60 days
Variation of uric acid in blood through enzymatic determination
Change from Baseline uric acid in blood at 15 days, 30 days, 45 days, 60 days
Change in body composition
Time Frame: Change from Baseline fat mass% at 60 days
Change of body composition (fat mass %) (BIVA)
Change from Baseline fat mass% at 60 days
Change in body composition
Time Frame: Change from Baseline fat mass% at 60 days
Change of body composition (fat mass %) (DXA)
Change from Baseline fat mass% at 60 days
Change in blood count
Time Frame: Change from Baseline blood count at 15 days, 30 days, 45 days, 60 days
Variation of blood count
Change from Baseline blood count at 15 days, 30 days, 45 days, 60 days
Change in microbiota
Time Frame: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 45 days, 60 days
Variation of prevalence of microbiota phyla through DNA sequencing of stools
Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 45 days, 60 days
Change in omics profile
Time Frame: Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Variation of lipidomic profile of stools through liquid and gas chromatography
Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Change in omics profile
Time Frame: Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Variation of proteomic profile of stools through liquid and gas chromatography
Change from Baseline omic profile of stools at 15, 30 days, 45 days, 60 days
Change in microvesicles
Time Frame: Change from Baseline microvesicles levels at 15, 30 days, 45 days, 60 days
Variation of urinary microvesicles levels
Change from Baseline microvesicles levels at 15, 30 days, 45 days, 60 days
Change in microvesicles
Time Frame: Change from Baseline microvesicles levels s at 15, 30 days, 45 days, 60 days
Variation of serum microvesicles levels
Change from Baseline microvesicles levels s at 15, 30 days, 45 days, 60 days
Change in basal metabolic rate
Time Frame: Change from Baseline basal metabolic rate at 60 days
Variation of basal metabolic rate (kcal)
Change from Baseline basal metabolic rate at 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 008/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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