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Trial record 19 of 496 for:    Supplement | maltodextrin

Effects of a Pre-Workout on Performance, Perceptual Responses, Energy Feelings and Muscular Properties, After a Training Microcycle in Adults.

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ClinicalTrials.gov Identifier: NCT04147741
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Collaborators:
Crown Sport Nutrition
Go Fit Spain
Information provided by (Responsible Party):
Fernando Naclerio, University of Greenwich

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.

Condition or disease Intervention/treatment Phase
Protein Deficiency Training Group, Sensitivity Fatigue Muscular Atrophy Psychological Dietary Supplement: Pre-Workout Supplement Other: Resistance Training Other: Endurance Training Not Applicable

Detailed Description:
Following inclusion, familiarization and baseline assessments, the participants will be randomly allocated to receive either a multi-ingredient, pre-workout supplement (PREW) or maltodextrin (CHO). Thereafter, the participants will take a 5-day microcycle, involving three resistance training sessions (Monday, Wednesday and Friday) intercalated with two endurance training sessions (Tuesday and Thursday). After the first interventional microcycle, and the 2-week washout period, the participants will switch to the other nutritional condition for continuation with the second 5-day identical microcycle. Assessments of muscle contractile properties via Tensiomyography on Vastus Medialis, Biceps Femoris Long Head and Anterior Deltoids will be taken before and after each resistance training session. Measurements of strength (Isometric Mid Thigh Pull) upper and lower body muscular power (Medicine Ball Throw and Vertical Jump) will be performed immediately after each resistance training workout. The supplements will be ingested 15 min before each training session, just before completing an energy feeling questionnaire. In addition, the perceptual response to training will be assessed during and 20 min after the completion of all workouts. The contribution of carbohydrate and fat metabolism will be estimated using a gas analyzer via the calculation of respiratory exchange ratio the (RER) during each endurance training session.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Multi-Ingredient Pre-Workout on Performance, Perceptual Responses, Subjective Feelings of Energy and Muscular Contractile Properties, After a Resistance and Endurance Training Microcycle in Older Participants.
Estimated Study Start Date : October 21, 2019
Estimated Primary Completion Date : December 6, 2019
Estimated Study Completion Date : December 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pre-Workout Supplement
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 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.

Other Name: Multi-Ingredient Supplement

Other: Resistance Training
-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.
Other Name: Free Weights Training

Other: Endurance Training
- 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.
Other Name: Cycloergometer Training

Placebo Comparator: Maltodextrin Supplement
A isoenergetic Maltodextrin supplement will be administered as placebo. With 250 ml of water.
Dietary Supplement: Pre-Workout 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.

Other Name: Multi-Ingredient Supplement

Other: Resistance Training
-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.
Other Name: Free Weights Training

Other: Endurance Training
- 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.
Other Name: Cycloergometer Training




Primary Outcome Measures :
  1. Tensiomyography [ Time Frame: Changes from 10 minutes Previous to post 1 hour after the completion of each workout session ]
    Fatigue and contractility assessment via Tensiomyography will be assessed in Biceps Femoris Long Head, Vastus Medialis, and Anterior Deltoid.

  2. Vertical Jump [ Time Frame: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session ]
    Flight Time (measured in seconds).

  3. Over Head Medicine Ball Throw [ Time Frame: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session ]
    Medicine Ball Throw (measured in meters and centimeters).

  4. Maximal Mid-Thigh Pull Isometrical Strength [ Time Frame: Changes from 10 minutes Previous to post 1 hour after the completion of each resistance training workout session ]
    Maximal Strength (measured in kilograms).

  5. Self Perceived Energy Feeling [ Time Frame: Before every Training Session and up to 1 week of training. ]

    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).



Secondary Outcome Measures :
  1. Whole Body Perceptual Response during Resistance Training [ Time Frame: Differences between first week and second week of training. ]
    Self Rate of Perceived Exertion (RPE) will be assessed via OMNI RES Scale (0-10 values) during resistance training (after every circuit) and 15-20 minutes after finishing each session.

  2. Perception of Effort during Endurance Training. [ Time Frame: Differences between first week and second week of training ]
    Borg Scale (6-20) will be used to collect the perception of effort during endurance training (every 5 minutes) and 15-20 minutes after each session.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147741


Contacts
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Contact: Fernando J Naclerio +44 (0)20 8331 8441 F.J.Naclerio@greenwich.ac.uk
Contact: Joel Puente +34 626610821 jp2979a@gre.ac.uk

Locations
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United Kingdom
University of Greenwich, Avery Hill Campus, Sparrows Farm. Avery Hill, London., United Kingdom, SE9 2BT Recruiting
London, Avery Hill, London., United Kingdom, SE9 2BT
Contact: Fernando J Naclerio    +44 (0)20 8331 8441    F.J.Naclerio@greenwich.ac.uk   
Contact: Joel Puente    +34626610821    jp2979a@gre.ac.uk   
Sponsors and Collaborators
University of Greenwich
Crown Sport Nutrition
Go Fit Spain
Investigators
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Principal Investigator: Joel Puente University of Greenwich

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Responsible Party: Fernando Naclerio, Principal Lecturer, University of Greenwich
ClinicalTrials.gov Identifier: NCT04147741    
Other Study ID Numbers: UGreenwich
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fernando Naclerio, University of Greenwich:
Fatigue
Supplement
Pre-Workout
Muscle
Recovery
Training
Strength
Endurance
Perceptual Response
Additional relevant MeSH terms:
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Muscular Atrophy
Protein Deficiency
Fatigue
Atrophy
Signs and Symptoms
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders