NCT04147741

Brief Summary

The investigation will be conducted as a double blinded, randomized, crossover within-participant comparison design with two 1-week intervention periods separated by 2-weeks for wash out, recovery, period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

October 16, 2019

Last Update Submit

November 2, 2020

Conditions

Keywords

FatigueSupplementPre-WorkoutMuscleRecoveryTrainingStrengthEndurancePerceptual Response

Outcome Measures

Primary Outcomes (5)

  • Tensiomyography

    Fatigue and contractility assessment via Tensiomyography will be assessed in Biceps Femoris Long Head, Vastus Medialis, and Anterior Deltoid.

    Changes from 10 minutes Previous to post 1 hour after the completion of each workout session

  • Vertical Jump

    Flight Time (measured in seconds).

    Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session

  • Over Head Medicine Ball Throw

    Medicine Ball Throw (measured in meters and centimeters).

    Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session

  • Maximal Mid-Thigh Pull Isometrical Strength

    Maximal Strength (measured in kilograms).

    Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session

  • Self Perceived Energy Feeling

    All participants will fill a short questionnaire (from 1 to 5 points) about their perception of energy before every training. Energy Feeling will be assessed (Evergy level, Fatigue Level, Feeling of Alertness, and Feeling of Focus for the task, valued from 1 = low energy to 5 = high energy).

    Before every Training Session and up to 1 week of training.

Secondary Outcomes (2)

  • Whole Body Perceptual Response during Resistance Training

    Differences between first week and second week of training.

  • Perception of Effort during Endurance Training.

    Differences between first week and second week of training

Study Arms (2)

Pre-Workout Supplement

EXPERIMENTAL

A 60 g dose of a commercially available pre-workout supplement providing 159 kcal including carbohydrates 15 g, essential amino acids 12 g, citrulline 3.5 g, Arginine, 3.5 g Taurine 1 g, L-Tyrosine 1 g, yerba mate 0.3 g and caffeine 0.4 g. With 250 ml of water.

Dietary Supplement: Pre-Workout SupplementOther: Resistance TrainingOther: Endurance Training

Maltodextrin Supplement

PLACEBO COMPARATOR

A isoenergetic Maltodextrin supplement will be administered as placebo. With 250 ml of water.

Dietary Supplement: Pre-Workout SupplementOther: Resistance TrainingOther: Endurance Training

Interventions

Pre-Workout SupplementDIETARY_SUPPLEMENT

One week familiarisation, one-week training, two weeks washout period and one-week training. 15 Minutes before every training, the Pre-Workout Arm (PRE-W) will take a Supplement shake, consisting of some ingredients (Multi-Ingredient, explained before) and the Placebo Comparator Arm (CHO) will drink a Placebo shake, consisting of Maltodextrin.

Also known as: Multi-Ingredient Supplement
Maltodextrin SupplementPre-Workout Supplement

-Resistance Training days (Monday-Wednesday-Friday): Before training starts, Tensiomyography and Energy Feeling will be assessed (Energy Level, Fatigue Level, Feeling of Alertness, and Feeling of Focus on the task). Immediately after finishing, Tensiomyography and Performance (Vertical Jump, Overhead Medicine Ball Throw, and Maximal Mid-Tigh Pull Isometric Strength) will be assessed. Training Protocol: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Parallel Squat; Bench Press; Alternate Box Set-Ups; Shoulder Press; Alternate Lunges; Up-right Row; Hip-Thrust; Squat on Isoinertial Fly-Wheel or Drop Jump). The participants will have to perform 16 repetitions of each exercise, with 30 seconds rest and 3 minutes rest after every set. If they can complete 16 repetitions easily, 2,5 to 5 kg will be added for the next set. Also, whole-body Perceptual Response will be assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.

Also known as: Free Weights Training
Maltodextrin SupplementPre-Workout Supplement

\- Endurance Training days (Tuesday-Thursday): Energy Feeling Questionnaire will be implemented before training. The training will consist of 30 minutes cycling at their Fatmax Intensity (\~60% Vo2max) on a Cycloergometer (estimated during familiarisation week). Also, the Heart Rate will be recorded during the whole training. Besides, Perception of Effort will be assessed using the 6-20 version of the Borg Scale every 5 minutes during training and 15 minutes after it has been completed.

Also known as: Cycloergometer Training
Maltodextrin SupplementPre-Workout Supplement

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy (no current injuries).
  • Between 45 and 70 years old.
  • Active.

You may not qualify if:

  • Injuries.
  • Never trained before.
  • Under 45 or over 70 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT

London, Avery Hill, London., SE9 2BT, United Kingdom

Location

MeSH Terms

Conditions

Protein DeficiencyHypersensitivityFatigueMuscular Atrophy

Interventions

Resistance TrainingEndurance Training

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Joel Puente

    University of Greenwich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: One week training (3 days Resistance Training and 2 Endurance Training in alternate days) with a Pre-Workout Supplement or Maltodextrin. 2 Weeks wash out period and then change supplement.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Lecturer

Study Record Dates

First Submitted

October 16, 2019

First Posted

November 1, 2019

Study Start

October 21, 2019

Primary Completion

March 21, 2020

Study Completion

March 21, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations