NCT06086691

Brief Summary

Dietary supplements to enhance exercise and athletic performance come in a variety of forms, including tablets, capsules, liquids, powders, and bars. Many of these products contain numerous ingredients in varied combinations and amounts. Among the more common ingredients are amino acids, protein, creatine, and caffeine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 12, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

October 11, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

CaffeineCreatine KinaseEndurance TrainingFitness CentersSkeletal MuscleStrength Training

Outcome Measures

Primary Outcomes (3)

  • Serum CK Levels

    Serum CK level is the amount of an enzyme called creatine kinase (CK) in the blood. CK is a type of protein present in the muscle cells in human body need which is essential for proper functioning. Levels of CK can rise after a heart attack, skeletal muscle injury, or strenuous exercise

    Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention

  • Serum LDH levels

    Lactate Dehydrogenase (LDH) is enzyme found in almost every cell of the human body, including your blood, muscles, brain, kidneys, and pancreas.

    Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention

  • Serum AST levels

    Aspartate aminotransferase (AST) are enzymes found mainly in the liver, but also found in red blood cells, heart cells, muscle tissue and other organs, such as the pancreas and kidneys.

    Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention

Secondary Outcomes (1)

  • Rating of fatigue scale/Numeric Rating Scale-Fatigue

    Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention

Study Arms (2)

Strength Training

EXPERIMENTAL

Strength training exercises along with caffeine supplementation

Other: Strength Training with Caffeine

Endurance Training

ACTIVE COMPARATOR

Endurance training exercises along with caffeine supplementation

Other: Endurance Training with Caffeine

Interventions

The intervention protocol consists of 5 types of strength training exercises. The following exercises will be performed for the strength training group: 1. bench press (3 sets of 10 reps) 2. biceps curl (3 sets of 10 reps) 3. triceps pushdown (3 sets of 10 reps) 4. leg press (3 sets of 10 reps) 5. leg extension (3 sets of 10 reps) Strength training would be performed in 3 sets of 10 repetitions with 2 minutes of rest between each exercise. This protocol will be performed in a 30-40-minute session. 10-15 minutes of light warm-up activities will be performed before the start of each exercise session. The intervention sessions would be carried out with a 3-5-day gap between the two intervention sessions.

Strength Training

The intervention protocol consists of 3 types of endurance training exercises. The following exercises will be performed by this group: 1. Cycling (15 min) 2. Running (20 min) 3. Rowing (10 min) The intervention sessions would be carried out with a 3-5-day gap between the two intervention sessions.

Endurance Training

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male gym athletes
  • Age: 18-40 years
  • Athletes with at least three days training session per week

You may not qualify if:

  • Athletes already on caffeine supplementation
  • Athletes with above normal serum enzyme levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University (RIU)

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Interventions

Resistance TrainingCaffeineEndurance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Noman Sadiq, MS-SPT

    Riphah International University, Islamabad.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized Crossover Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

January 12, 2022

Primary Completion

November 30, 2022

Study Completion

January 31, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations