Clinical trial NCT04476615: Effects of Fasting-Mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance
Official title: Effects of Fasting-mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue; Muscle, Heart
Fasting
Diet, Healthy
Fatigue, Mental
Keywords: fatigue
fasting-mimicking diet
healthy
young adults
exercise
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2020-07-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in time to exhaustion (TTE)
timeFrame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
measure: Change in maximal voluntary contraction (MVC)
timeFrame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
measure: Change in voluntary (muscle) activation (VA)
timeFrame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
measure: Change in resting twitch force (RT)
timeFrame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
measure: Change in oxygen consumption (VO2)
timeFrame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
measure: Change in peak (task-specific) oxygen consumption (VO2)
timeFrame: baseline (T1) and after 2 months (T4).
measure: Change in femoral (artery) blood flow (FBF)
timeFrame: 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)
measure: Change in median frequency of the power spectrum density of EMG
timeFrame: during the performance test at each time point: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Secondary outcomes:
measure: Change in carbon dioxide (VCO2) production
timeFrame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
measure: Change in minute ventilation (VE)
timeFrame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
measure: Change in heart rate (HR)
timeFrame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
measure: Change in Peak Power Output (Wpeak)
timeFrame: baseline (T1) and after 2 months (T4).
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Department of Neurosciences, Biomedicine and Movement Sciences
Study officials:
affiliation: Department of Neurosciences, Biomedicine and Movement Sciences - University of Verona
name: Matteo Bertucco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.