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

NCT07100587 | Completed

• 1 other identifier: 14
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Acromegaly

Keywords

ketogenic diet; mediterranean diet

Outcome Measures

Primary Outcomes (1)

• Disease control

  Change in serum IGF-1 levels after ketogenic and Mediterranean diets (paired comparison)

  3 weeks

Secondary Outcomes (8)

• Metabolic outcomes

  3 weeks

• Metabolic outcomes

  3 weeks

• Metabolic outcomes

  3 weeks

• Anthropometric outcomes

  3 weeks

• Anthropometric outcomes

  3 weeks

Study Arms (2)

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.

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.

Behavioral: Mediterranean diet

Interventions

Ketogenic diet BEHAVIORAL

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.

Arm A - Ketogenic Diet (3 weeks)

Mediterranean diet BEHAVIORAL

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.

Arm B: Mediterranean Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Policlinico Paolo Giaccone

Palermo, Italy

Location

MeSH Terms

Conditions

Acromegaly

Interventions

Diet, Ketogenic; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, Plant-Based

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 3, 2025
• Study Start: June 30, 2024
• Primary Completion: May 31, 2025
• Study Completion: July 2, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)