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Fatigue; Muscle, HeartFMD_ExerciseNCT04476615

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

A study testing Fasting-Mimicking Diet (ProLon®) in people with Fatigue; Muscle, Heart and Fasting, run by Universita di Verona at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Fatigue; Muscle, Heart, Fasting, Diet, Healthy
What is being tested?
Fasting-Mimicking Diet (ProLon®)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteItaly
Study dates
4 Dec 2017to 16 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Department of Neurosciences, Biomedicine and Movement Sciences

    Verona, 37134

Other trials in Italy

About this study

Official title: 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).

Being tested
Fasting-Mimicking Diet (ProLon®), Placebo bars
Keywords
fatigue, fasting-mimicking diet, healthy, young adults, exercise
Medical subject headings
Fatigue, Fasting, Mental Fatigue, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fasting-Mimicking Diet (ProLon®)Dietary supplement

    Also called Dieta Mima Digiuno® (italian name)

    Dietary restriction: Fasting-Mimicking Diet (ProLon®). 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).

  • Placebo barsDietary 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).

Study groups in NCT04476615
Study groupRoleWhat they receive
FMDExperimentalFasting-Mimicking diet (ProLon®)
Receives: Dietary Supplement: Fasting-Mimicking Diet (ProLon®)
PlaceboPlacebo comparatorLow-energy bars (L-Nutra®) supplementation
Receives: Dietary Supplement: Placebo bars

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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].

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

  3. 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.

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

  4. Change in resting twitch force (RT)

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

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

  5. Change in oxygen consumption (VO2)

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

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

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

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

    Measured: baseline (T1) and after 2 months (T4).

  7. 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)

    Measured: 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)

  8. 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.

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

Secondary outcomes (4)

  1. 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].

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

  2. Change in minute ventilation (VE)

    Difference in ventilatory response at rest and while exercising measured by a breath-by-breath system [L/min].

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

  3. Change in heart rate (HR)

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

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

  4. Change in Peak Power Output (Wpeak)

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

    Measured: baseline (T1) and after 2 months (T4).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start4 Dec 2017
  3. Primary completion16 Jan 2020
  4. Study completion16 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04476615
Sponsor's protocol ID
140166
Acronym
FMD_Exercise
Status last verified
Jul 2020
First submitted
7 Jul 2020
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Publications

  • 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.

    PubMed 35034194

Questions about this trial

What is this clinical trial studying?

A study testing Fasting-Mimicking Diet (ProLon®) in people with Fatigue; Muscle, Heart and Fasting, run by Universita di Verona at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in time to exhaustion (TTE) (time frame: baseline (T1); day 5 (1°diet cycle - T1), after 2 months (T3 and T4)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04476615, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.

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