Effects of Fasting-Mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance

NCT04476615 | Completed

• 1 other identifier: 140166
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to test a Fasting Mimicking Diet (FMD) for its efficacy on improving muscular resistance and endurance. The investigators will perform a randomized clinical trial to test the efficacy of the FMD on improving muscular strength, muscular resistance and endurance in physically active young adults (18-40 years of age). The study will include two arms: Placebo (Placebo diet) and FMD (3 cycles of 5-day fasting-mimicking diet within two months). Study endpoints will include muscular strength evaluation of lower limbs, cardio-pulmonary responses, neuromuscular function and muscle architecture. Subjects will be evaluated 4 times within 3 months: at baseline (T1), after the 1st cycle of diet (T2), 7 to 15 days after the 3rd cycle of diet maintaining baseline intensity (T3) and with re-assessment of Peak Power Output (T4).

Conditions

Fatigue; Muscle, Heart; Fasting; Diet, Healthy; Fatigue, Mental

Keywords

fatigue; fasting-mimicking diet; healthy; young adults; exercise

Outcome Measures

Primary Outcomes (8)

• Difference in time to exhaustion (TTE)

  Difference between time points in time duration \[s\] of the exercise at a given power output (85%) and cadence (60 RPM), before the given work rate could not be sustained.

  baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in maximal voluntary contraction (MVC)

  Variation between time points in maximal force voluntarily produced by the knee extensor muscles pre- and immediately post exercise, considering for lever length \[N\*m\].

  baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in voluntary (muscle) activation (VA)

  Change between time points in the percentage of muscle activated by volition. \[%\] To quantify voluntary activation, the amplitude of the superimposed twitch is expressed as a fraction of the twitch evoked by the same stimulus in the relaxed muscle.

  baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in resting twitch force (RT)

  Force elicited at rest by electrical stimulation of the femoral nerve, considering for lever length \[N\*m\].

  baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in oxygen consumption (VO2)

  Variations of mean oxygen consumption at rest and at each minute while exercising (performance test).

  baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in peak (task-specific) oxygen consumption (VO2)

  Peak oxygen consumption during the incremental test (maximal value during a 30" time-window).

  baseline (T1) and after 2 months (T4).

• Change in femoral (artery) blood flow (FBF)

  Measurements of common femoral arterial blood velocity (Vmean) and vessel diameter will be performed using ultrasound Doppler, distal to the inguinal ligament and proximal to the bifurcation of the deep and superficial femoral arteries. (FBF = Vmean p (vessel diameter/2)\^2 \* 60)

  at rest and during the performance test. Differences between each time point will be assessed: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in median frequency of the power spectrum density of EMG

  EMG signal from the vastus lateralis (VL) muscle was recorded throughout exercise to estimate the output of spinal motoneurons and the development of peripheral fatigue.

  during the performance test at each time point: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

Secondary Outcomes (4)

• Change in carbon dioxide (VCO2) production

  baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in minute ventilation (VE)

  baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in heart rate (HR)

  baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)

• Change in Peak Power Output (Wpeak)

  baseline (T1) and after 2 months (T4).

Study Arms (2)

FMD

EXPERIMENTAL

Fasting-Mimicking diet (ProLon®)

Dietary Supplement: Fasting-Mimicking Diet (ProLon®)

Placebo

PLACEBO COMPARATOR

Low-energy bars (L-Nutra®) supplementation

Dietary Supplement: Placebo bars

Interventions

Fasting-Mimicking Diet (ProLon®) DIETARY_SUPPLEMENT

Dietary restriction: Fasting-Mimicking Diet (ProLon®). 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).

Also known as: Dieta Mima Digiuno® (italian name)

FMD

Placebo bars DIETARY_SUPPLEMENT

Dietary supplementation: Low-energy bars (L-Nutra®) to integrate the daily nutritional habits - one bar per day. 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male sex;
• Age Range: 18-40 years old;
• Body Mass Index (BMI) range between 18.5 and 30;
• METs minutes per week - calculated by International physical activity questionnaire (IPAQ) - between 600 and 3000.

You may not qualify if:

• Female sex;
• History of muscle, joints and nerves injuries to the upper and/or lower limbs in the previous 12 months;
• Body Mass Index (BMI) below 18.5 and above 30;
• METs minutes per week - calculated by International physical activity questionnaire (IPAQ) - below 600 or above 3000.

Sponsors & Collaborators

• Universita di Verona: lead
• University of Southern California: collaborator

Study Sites (1)

Department of Neurosciences, Biomedicine and Movement Sciences

Verona, 37134, Italy

Location

Related Publications (1)

• Nardon M, Venturelli M, Ruzzante F, Longo VD, Bertucco M. Fasting-Mimicking-Diet does not reduce skeletal muscle function in healthy young adults: a randomized control trial. Eur J Appl Physiol. 2022 Mar;122(3):651-661. doi: 10.1007/s00421-021-04867-2. Epub 2022 Jan 16.

  PMID: 35034194 DERIVED

MeSH Terms

Conditions

Fatigue; Fasting; Mental Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Behavioral Symptoms

Study Officials

• Matteo Bertucco, PhD

  Department of Neurosciences, Biomedicine and Movement Sciences - University of Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 20, 2020
• Study Start: December 4, 2017
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available upon request to the corresponding author after publication of the original article.

Locations

IT (1)