Effect of Ketogenic Diet on Muscle Hypertrophy

Effects of Ketogenic Diet on Muscle Hypertrophic Response to Resistance Exercise

The purpose of this study is to investigate the effects of 4 weeks of carbohydrate deprivation (through a ketogenic diet) on hypertrophy signalling after a single bout of exercise in healthy trained male subjects, and the impact on body composition, muscle strength, and blood parameters.

Study Overview

• Status: Recruiting
• Conditions: Healthy Nutrition
• Intervention / Treatment: Other: resistance training; Other: ketogenic diet; Other: western diet

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Cerullo; Phone Number: +00393200218377; Email: giuseppe.cerullo@unipd.it

Study Locations

• Italy
  • Padua, Italy, 35131
    • Recruiting
    • Nutex LAB
    • Contact: Antonio Paoli, MD; Phone Number: +390498275318; Email: antonio.paoli@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• at least 2 years of resistance-training experience
• Body mass index: more than 18 kg/m2 and less than 30 kg/m2

Exclusion Criteria:

• metabolic diseases or noncommunicable diseases (cardiovascular, liver, respiratory, cancer, etc)
• experience with the ketogenic diet (last six months)
• acute inflammatory status
• treatment with steroids in the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ketogenic diet; Participants will perform a single exercise bout after 4 weeks of resistance training combined with a ketogenic diet (KD group).	Other: resistance training; All participants perform a four-day resistance training aimed to stimulate a hypertrophic response.; Other: ketogenic diet; Subjects allocated to the ketogenic diet arm (KD group) consume less than 50 g of carbohydrates per day.
Active Comparator: western diet; Participants will perform a single exercise bout after 4 weeks of resistance training combined with a western diet (WD group).	Other: resistance training; All participants perform a four-day resistance training aimed to stimulate a hypertrophic response.; Other: western diet; Subjects allocated to the western diet arm (WD group) consume a standard diet based on 55% of their daily calories from carbohydrates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mammalian target of rapamycin (mTOR) signalling	Measurement of the change in muscle protein anabolic signalling pathway in response to a single bout of resistance exercise by western blot analysis.	Change from baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle mass	Measurement of the change in kilograms of muscle mass via Dexa	Change from baseline to 4 weeks

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Antonio Paoli, MD, University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KETO-EX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No