Effect of Ketogenic Diet on Muscle Hypertrophy

NCT05897567 | Unknown

• 1 other identifier: KETO-EX
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Skeletal muscle mass

  Change from baseline to 4 weeks

Study Arms (2)

ketogenic diet

EXPERIMENTAL

Participants will perform a single exercise bout after 4 weeks of resistance training combined with a ketogenic diet (KD group).

Other: resistance training; Other: ketogenic diet

western diet

ACTIVE COMPARATOR

Participants will perform a single exercise bout after 4 weeks of resistance training combined with a western diet (WD group).

Other: resistance training; Other: western diet

Interventions

resistance training OTHER

All participants perform a four-day resistance training aimed to stimulate a hypertrophic response.

ketogenic diet; western diet

ketogenic diet OTHER

Subjects allocated to the ketogenic diet arm (KD group) consume less than 50 g of carbohydrates per day.

ketogenic diet

western diet OTHER

Subjects allocated to the western diet arm (WD group) consume a standard diet based on 55% of their daily calories from carbohydrates.

western diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Nutex LAB

Padua, 35131, Italy

RECRUITING

MeSH Terms

Interventions

Resistance Training; Diet, Ketogenic; Diet, Western

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Antonio Paoli, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Cerullo

CONTACT

+00393200218377; giuseppe.cerullo@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 9, 2023
• Study Start: June 20, 2023
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 10, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)