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

University of Palermo

Status: Completed

Conditions: Acromegaly

Treatments: Behavioral: Mediterranean diet; Behavioral: Ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07100587

14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Arm A - Ketogenic Diet (3 weeks)

Experimental group

Description:

Participants will follow a structured ketogenic diet for 3 weeks (\~1200 kcal/day, \<30 g/day carbohydrates) to induce nutritional ketosis.

Treatment:

Behavioral: Ketogenic diet

Arm B: Mediterranean Diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mediterranean diet