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

Primary Purpose

Fatigue; Muscle, Heart, Fasting, Diet, Healthy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fasting-Mimicking Diet (ProLon®)
Placebo bars
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fatigue; Muscle, Heart focused on measuring fatigue, fasting-mimicking diet, healthy, young adults, exercise

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Neurosciences, Biomedicine and Movement Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FMD

Placebo

Arm Description

Fasting-Mimicking diet (ProLon®)

Low-energy bars (L-Nutra®) supplementation

Outcomes

Primary Outcome Measures

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.
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].
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.
Change in resting twitch force (RT)
Force elicited at rest by electrical stimulation of the femoral nerve, considering for lever length [N*m].
Change in oxygen consumption (VO2)
Variations of mean oxygen consumption at rest and at each minute while exercising (performance test).
Change in peak (task-specific) oxygen consumption (VO2)
Peak oxygen consumption during the incremental test (maximal value during a 30" time-window).
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)
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.

Secondary Outcome Measures

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].
Change in minute ventilation (VE)
Difference in ventilatory response at rest and while exercising measured by a breath-by-breath system [L/min].
Change in heart rate (HR)
Difference in the cardiac response at rest and while exercising measured by a heart rate monitor system.
Change in Peak Power Output (Wpeak)
Difference in maximal power [Watts] achieved (last completed 1-min step) during the incremental test sessions.

Full Information

First Posted
July 7, 2020
Last Updated
July 14, 2020
Sponsor
Universita di Verona
Collaborators
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04476615
Brief Title
Effects of Fasting-Mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance
Acronym
FMD_Exercise
Official Title
Effects of Fasting-mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
January 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
Collaborators
University of Southern California

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue; Muscle, Heart, Fasting, Diet, Healthy, Fatigue, Mental
Keywords
fatigue, fasting-mimicking diet, healthy, young adults, exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMD
Arm Type
Experimental
Arm Description
Fasting-Mimicking diet (ProLon®)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Low-energy bars (L-Nutra®) supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Fasting-Mimicking Diet (ProLon®)
Other Intervention Name(s)
Dieta Mima Digiuno® (italian name)
Intervention Description
Dietary restriction: Fasting-Mimicking Diet (ProLon®). 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo bars
Intervention Description
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 Outcome Measure Information:
Title
Difference in time to exhaustion (TTE)
Description
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.
Time Frame
baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Title
Change in maximal voluntary contraction (MVC)
Description
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].
Time Frame
baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Title
Change in voluntary (muscle) activation (VA)
Description
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.
Time Frame
baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Title
Change in resting twitch force (RT)
Description
Force elicited at rest by electrical stimulation of the femoral nerve, considering for lever length [N*m].
Time Frame
baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Title
Change in oxygen consumption (VO2)
Description
Variations of mean oxygen consumption at rest and at each minute while exercising (performance test).
Time Frame
baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Title
Change in peak (task-specific) oxygen consumption (VO2)
Description
Peak oxygen consumption during the incremental test (maximal value during a 30" time-window).
Time Frame
baseline (T1) and after 2 months (T4).
Title
Change in femoral (artery) blood flow (FBF)
Description
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)
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)
Title
Change in median frequency of the power spectrum density of EMG
Description
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.
Time Frame
during the performance test at each time point: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Secondary Outcome Measure Information:
Title
Change in carbon dioxide (VCO2) production
Description
Variation of physiological production of CO2 at rest and while exercising measured by a breath-by-breath system [L/min].
Time Frame
baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Title
Change in minute ventilation (VE)
Description
Difference in ventilatory response at rest and while exercising measured by a breath-by-breath system [L/min].
Time Frame
baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Title
Change in heart rate (HR)
Description
Difference in the cardiac response at rest and while exercising measured by a heart rate monitor system.
Time Frame
baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)
Title
Change in Peak Power Output (Wpeak)
Description
Difference in maximal power [Watts] achieved (last completed 1-min step) during the incremental test sessions.
Time Frame
baseline (T1) and after 2 months (T4).

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Bertucco, PhD
Organizational Affiliation
Department of Neurosciences, Biomedicine and Movement Sciences - University of Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosciences, Biomedicine and Movement Sciences
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35034194
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.
Results Reference
derived

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

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