NCT05769101

Brief Summary

The investigation will be conducted as a double blinded, randomized, parallel between treatment conditions comparison design with two different groups ingesting a different supplement each one.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

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

Study Start

First participant enrolled

February 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

February 20, 2023

Last Update Submit

March 2, 2023

Conditions

Keywords

FatigueSupplementProteinCreatineResistance TrainingRecoveryStrengthRate of Perceived ExertionMuscle

Outcome Measures

Primary Outcomes (5)

  • Vertical Jump

    Height (measured in centimetres)

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • Chest Medicine Ball Throw

    Distance (measured in centimetres)

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • Muscle Thickness

    Thickness of the Vastus Lateralis and the Elbow Flexors of the dominant limbs

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

  • 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).

    [Time Frame: Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program]

  • White Blood Cells count

    White blood cell (WBC) count including a five-part differential

    Changes from 3 days previous to, and 3 days after the completion of the 6-weeks training program

Study Arms (2)

Multi-Ingredient Post-Workout Supplement

EXPERIMENTAL

A 60 g dose of a commercially available Recovery supplement providing \~205 kcal including Proteins (+EAA), Carbohydrates, Creatine, and Vitamin D. Diluted in 350 ml of water.

Dietary Supplement: Ingestion of a Post-Workout Supplement

Maltodextrin Supplement

PLACEBO COMPARATOR

An isoenergetic Maltodextrin supplement will be administered as placebo. Dissolved in 350 ml of water.

Dietary Supplement: Ingestion of a Maltodextrin Supplement

Interventions

The Post-Workout Supplement is administered 15 minutes after the completion of training sessions. No supplementation is administered in non-training days. The Resistance Training is performed in alternate days. The training Protocol is: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Alternate Box Step-Ups, Bench Press; Parallel Squat; Up-right Row; Deadlift; Alternate Lunges; Shoulder Press; Leg Extension). The participants 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 are added for the next set. Also, whole-body Perceptual Response is assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.

Multi-Ingredient Post-Workout Supplement

The Maltodextrin Supplement is administered 15 minutes after the completion of training sessions. No supplementation is administered in non-training days. The Resistance Training is performed in alternate days. The training Protocol is: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Alternate Box Step-Ups, Bench Press; Parallel Squat; Up-right Row; Deadlift; Alternate Lunges; Shoulder Press; Leg Extension). The participants 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 are added for the next set. Also, whole-body Perceptual Response is assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.

Maltodextrin Supplement

Eligibility Criteria

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

You may qualify if:

  • Healthy (no injuries, illnesses or medication intake).
  • Between 45 and 65 years old.
  • Active and familiarised with Resistance Training.

You may not qualify if:

  • Unhealthy (illnesses or medication intake) or injured.
  • Untrained.
  • Young (\<45 y.o.) or elderly (\>65 y.o.).

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

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 6 Weeks of resistance training (alternate days), with a post-workout or Maltodextrin intake.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 15, 2023

Study Start

February 1, 2022

Primary Completion

May 30, 2022

Study Completion

June 1, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations