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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2020-01-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Nutritional Interventions on Exercise-induced Muscle Damage

NCT02839525

Muscle Damage

COMPLETED NA

Effects of a Time Restricted Eating Protocol on Resistance Training Men

NCT04668378

Fasting Healthy

COMPLETED NA

Combining Nutrition Supplementation With an Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay

NCT05325697

Frailty Sarcopenia Malnutrition; Protein

UNKNOWN NA

Fasting and Exercise-induced Changes in Human Skeletal Muscle

NCT03811717

Skeletal Muscle Energetics

COMPLETED NA

Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

NCT03904615

Aging

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FMD

Fasting-Mimicking diet (ProLon®)

Group Type EXPERIMENTAL

Fasting-Mimicking Diet (ProLon®)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Low-energy bars (L-Nutra®) supplementation

Group Type PLACEBO_COMPARATOR

Placebo bars

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fasting-Mimicking Diet (ProLon®)

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

Placebo bars

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).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dieta Mima Digiuno® (italian name)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes