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

Diet, Healthy Clinical Trial

— FMD_Exercise  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476615
• Other study ID #: 140166
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: January 16, 2020

Study information

• Verified date: July 2020
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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).
• 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).

Locations

Country	Name	City	State
Italy	Department of Neurosciences, Biomedicine and Movement Sciences	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Universita di Verona	University of Southern California

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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).
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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).