Effect of Ketogenic Diet on Muscle Hypertrophy

• Sponsor: University of Padova (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05897567
• Collaborator: (none)
• Enrollment: 24
• Arms: 2
• Anticipated Duration (Months): 18.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Nutrition	Other: resistance training; Other: ketogenic diet; Other: western diet	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Ketogenic Diet on Muscle Hypertrophic Response to Resistance Exercise
• Anticipated Study Start Date: Jun 20, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. mammalian target of rapamycin (mTOR) signalling [Change from baseline to 4 weeks]

   Measurement of the change in muscle protein anabolic signalling pathway in response to a single bout of resistance exercise by western blot analysis.

Secondary Outcome Measures

1. Skeletal muscle mass [Change from baseline to 4 weeks]

   Measurement of the change in kilograms of muscle mass via Dexa

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Padova
• ClinicalTrials.gov Identifier: NCT05897567
• Other Study ID Numbers: KETO-EX
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 9, 2023