NCT04277364

Brief Summary

There are indications that phosphatidic acid (PA) supplementation is capable of enhancing gains in strength and muscle mass in response to strength training, although the literature is still incipient and controversial. Given the possible benefits in terms of maintenance and increased skeletal muscle mass, which still need confirmation, this study aims to examine the effectiveness of PA supplementation in two different doses in increasing skeletal muscle mass and strength in adult men undergoing to 8 weeks of strength training. For this, about 45 men will be randomly allocated to one of three treatments at a ratio of 1:1:1: PA 750mg per day, PA 375mg per day, or placebo (cornstarch, 750mg per day). All participants will undergo a 8-week strength training program, 3 times a week, totaling 24 sessions, which will begin with the start of supplementation. Individuals will be assessed for maximum dynamic strength of upper and lower limbs, resistance to dynamic strength of upper and lower limbs, body composition, muscle cross-sectional area and food consumption. Samples of venous blood will also be collected to determine the concentration of creatine kinase (CK), lactate dehydrogenase (LDH), testosterone, insulin-like growth factor type 1 (IGF-1), growth hormone (GH) and cortisol. These evaluations will be carried out before (PRE) and after (POST) the period of supplementation and training. Additional blood samples will be taken 48 hours after the first and last training sessions, for specific determination of blood muscle damage markers: CK and LDH.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

12 months

First QC Date

February 9, 2020

Last Update Submit

October 2, 2020

Conditions

Keywords

Dietary SupplementationsAthletic PerformancePhosphatidic acid

Outcome Measures

Primary Outcomes (2)

  • Compare muscle strength responses

    Assessments of the maximum dynamic strength and the dynamic strength resistance of the upper and lower limbs will be performed before and after treatment. The evaluation of the maximum dynamic strength will be performed on leg-press equipment, for the lower limbs, and bench press, for the upper limbs. The tests for assessing maximum dynamic strength (1RM) will follow methods proposed by the American Society for Exercise Physiology (Brown \& Weir, 2001). After determining the 1-RM, the test will be repeated 5 days later to confirm the maximum loads. The tests will be repeated as many times as necessary until the difference between charges is less than 5%. The evaluation of dynamic strength endurance will be performed in leg-press and bench press exercises where the volunteers must perform repetitions until fatigue with a load equivalent to 70% of 1RM. Participants will have to perform the maximum number of repetitions until reaching the concentric failure.

    8 weeks

  • Compare muscle hypertrophy responses

    The architecture of the vastus lateralis and rectus femoris muscles will be evaluated with a B-mode ultrasound, with a linear vector transducer and a frequency of 7.5 MHz (Samsung, Sonaance R3).For this, the volunteers will be placed in the supine position with legs extended. An experienced researcher will delimit, with semi-permanent ink, the point on which the measurements will be taken. The skin will then be marked transversely (angle of 90 with the lateral epicondyle of the tibia) every 2 cm for measurements. The transducer, aligned perpendicular to the muscle, will be moved from a central position to a lateral position along the pre-established boundaries. The contact pressure will be kept minimal and stable during each measurement. Finally, the images obtained will be assembled in such a way that the cross-sectional area of the vast side is established, which will be subsequently evaluated by the Madena 3.2.1 free-use image digitization software.

    8 weeks

Secondary Outcomes (1)

  • Assess effects on body composition

    8 weeks

Study Arms (3)

High dose phosphatidic acid

ACTIVE COMPARATOR

750mg of phosphatidic acid per day for 8 weeks

Dietary Supplement: phosphatidic acid supplementationOther: Strength training

Low dose phosphatidic acid

ACTIVE COMPARATOR

375mg of phosphatidic acid per day for 8 weeks

Dietary Supplement: phosphatidic acid supplementationOther: Strength training

Placebo

PLACEBO COMPARATOR

750mg of corn starch per day for 8 weeks

Other: Placebo (corn starch supplementation)Other: Strength training

Interventions

The total daily doses will be distributed in 3 individual doses: in the group that will ingest 750mg per day, the individual doses will be 250mg, while in the group that will ingest 375mg per day, the individual doses will be 125mg. The capsules should be consumed at breakfast, 30 minutes before each training session (or at lunch, on days when there is no training) and at dinner.

High dose phosphatidic acidLow dose phosphatidic acid

Three individual doses of corn starch will be consumed per day. The capsules should be consumed at breakfast, 30 minutes before each training session (or at lunch, on days when there is no training) and at dinner.

Placebo

All participants will be submitted to a 8-week strength training program, with 3 training sessions per week, totaling 24 training sessions.

High dose phosphatidic acidLow dose phosphatidic acidPlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • months of continuous strength training, with a minimum weekly volume of 3 hours of training
  • Minimum dynamic maximum strength index of 1.1 times the body weight for bench press and 2.5 times the body weight for leg press
  • Consume\> 1.7g of protein per kilo of body weight in their diets
  • Keeping body weight stable in the 3 months prior to the study

You may not qualify if:

  • History of use of anabolic-androgenic steroids
  • Smoking
  • Use of dietary supplements that may affect strength or muscle mass in the last 3 months before the study
  • Presence of infectious disease in the last 4 weeks prior to the study
  • Chronic use of drugs that can potentially affect the variables that will be assessed
  • Any condition that prevents the performance of maximum strength tests or strength training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Education and Sports, University of Sao Paulo

São Paulo, 05508-030, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertrophy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Guilherme Giannini Artioli, phD

    School of Physical Education and Sport, University of São Paulo

    STUDY CHAIR

Central Study Contacts

Guilherme Giannini Artioli, phD

CONTACT

Cinthya Nascimento Marinho

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2020

First Posted

February 20, 2020

Study Start

August 17, 2020

Primary Completion

July 30, 2021

Study Completion

December 31, 2021

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations