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Completed

NCT Number: NCT04476615

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).

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Key information

Conditions

Fatigue; Muscle, Heart Behavior Behavioral Symptoms Diet, Healthy Fasting Fatigue Fatigue, Mental Feeding Behavior Mental Fatigue Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosciences, Biomedicine and Movement Sciences

Verona, 37134, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Dieta Mima Digiuno® (italian name)

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).

Primary outcomes

  1. Difference in time to exhaustion (TTE)

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

    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.

  2. Change in maximal voluntary contraction (MVC)

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

    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].

  3. Change in voluntary (muscle) activation (VA)

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

    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.

  4. Change in resting twitch force (RT)

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

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

  5. Change in oxygen consumption (VO2)

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

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

  6. Change in peak (task-specific) oxygen consumption (VO2)

    Time frame: baseline (T1) and after 2 months (T4).

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

  7. Change in femoral (artery) blood flow (FBF)

    Time frame: 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)

    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)

  8. Change in median frequency of the power spectrum density of EMG

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

    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.

Secondary outcomes

  1. Change in carbon dioxide (VCO2) production

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

    Variation of physiological production of CO2 at rest and while exercising measured by a breath-by-breath system [L/min].

  2. Change in minute ventilation (VE)

    Time frame: 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].

  3. Change in heart rate (HR)

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

    Difference in the cardiac response at rest and while exercising measured by a heart rate monitor system.

  4. Change in Peak Power Output (Wpeak)

    Time frame: baseline (T1) and after 2 months (T4).

    Difference in maximal power [Watts] achieved (last completed 1-min step) during the incremental test sessions.

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Collaborators

  • University of Southern California

Registry information

Acronym: FMD_Exercise

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 20, 2020
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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