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| Name | Class |
|---|---|
| University of Southern California | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMD | Experimental | Fasting-Mimicking diet (ProLon®) |
|
| Placebo | Placebo Comparator | Low-energy bars (L-Nutra®) supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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). |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matteo Bertucco, PhD | Department of Neurosciences, Biomedicine and Movement Sciences - University of Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosciences, Biomedicine and Movement Sciences | Verona | 37134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35034194 | Derived | 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. |
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The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Data will be available upon request to the corresponding author after publication of the original article.
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D005215 | Fasting |
| D005222 | Mental Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| 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). |
|
| 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) |
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). |
| D001526 | Behavioral Symptoms |