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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04147741
Other study ID # UGreenwich
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2019
Est. completion date March 21, 2020

Study information

Verified date November 2020
Source University of Greenwich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 21, 2020
Est. primary completion date March 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 70 Years
Eligibility 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.

Study Design


Intervention

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:
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.
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.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
University of Greenwich Crown Sport Nutrition, Go Fit Spain

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Whole Body Perceptual Response during Resistance 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. Differences between first week and second week of training.
Secondary Perception of Effort during Endurance 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. Differences between first week and second week of training
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