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

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

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).

Study Overview

• Status: Completed
• Conditions: Diet, Healthy; Fasting; Fatigue, Mental; Fatigue; Muscle, Heart
• Intervention / Treatment: Dietary supplement: Fasting-Mimicking Diet (ProLon®); Dietary supplement: Placebo bars

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

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • Department of Neurosciences, Biomedicine and Movement Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMD; Fasting-Mimicking diet (ProLon®)	Dietary supplement: Fasting-Mimicking Diet (ProLon®); Dietary restriction: Fasting-Mimicking Diet (ProLon®). 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).; Other Names: Dieta Mima Digiuno® (italian name)
Placebo Comparator: Placebo; Low-energy bars (L-Nutra®) supplementation	Dietary supplement: Placebo bars; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in carbon dioxide (VCO2) production	Variation of physiological production of CO2 at rest and while exercising measured by a breath-by-breath system [L/min].	baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Change in minute ventilation (VE)	Difference in ventilatory response at rest and while exercising measured by a breath-by-breath system [L/min].	baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Change in heart rate (HR)	Difference in the cardiac response at rest and while exercising measured by a heart rate monitor system.	baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Change in Peak Power Output (Wpeak)	Difference in maximal power [Watts] achieved (last completed 1-min step) during the incremental test sessions.	baseline (T1) and after 2 months (T4).

Collaborators and Investigators

• Sponsor: Universita di Verona
• Collaborators: University of Southern California
• Investigators: Principal Investigator: Matteo Bertucco, PhD, Department of Neurosciences, Biomedicine and Movement Sciences - University of Verona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): January 16, 2020
• Study Completion (Actual): January 16, 2020

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: fatigue; exercise; young adults; healthy; fasting-mimicking diet
• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Mental Fatigue
• Other Study ID Numbers: 140166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: Data will be available upon request to the corresponding author after publication of the original article.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes