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

U

University of Verona

Status

Completed

Conditions

Fatigue, Mental
Fatigue; Muscle, Heart
Fasting
Diet, Healthy

Treatments

Dietary Supplement: Fasting-Mimicking Diet (ProLon®)
Dietary Supplement: Placebo bars

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

24 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups, including a placebo group

FMD
Experimental group
Description:
Fasting-Mimicking diet (ProLon®)
Treatment:
Dietary Supplement: Fasting-Mimicking Diet (ProLon®)
Placebo
Placebo Comparator group
Description:
Low-energy bars (L-Nutra®) supplementation
Treatment:
Dietary Supplement: Placebo bars

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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