MedTrace Logo

Ketogenic vs. Mediterranean Diet on Metabolic and Hormonal Parameters in Patients With Active Acromegaly

NCT07100587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-09-05

No results posted yet for this study

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. 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.

Conditions

Interventions

BEHAVIORAL

Ketogenic diet

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.

BEHAVIORAL

Mediterranean diet

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.

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-05-31
Completion
2025-07-02

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100587 on ClinicalTrials.gov