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Muscle HypotrophyNCT07410195

Resistance Training Adaptations and Caffeine Intake

A study testing Caffeine (Constant Daily Dose), Caffeine (Escalating Dose) and Caffeine (Training Days Only) in people with Muscle Hypotrophy and Exercise Performance, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This parallel-group, randomized, double-blind, placebo-controlled trial investigates the effects of three different caffeine supplementation strategies on resistance training-induced adaptations in 120 caffeine-naive, inactive young adult males. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
What is being tested?
Caffeine (Constant Daily Dose), Caffeine (Escalating Dose) and Caffeine (Training Days Only)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2026to 7 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male sex and age between 18 and 30 years
  • Daily caffeine intake <100 mg/day
  • resistance-training experience ≥1 year and <3 years
  • Body mass index (BMI) between 18.5-25 kg/m2
  • Willingness to attend all training and testing sessions regularly
  • Provision of written informed consent after being fully informed about the study

Who cannot join

  • Presence of cardiovascular, metabolic, renal, hepatic, or other serious chronic diseases
  • Diagnosed psychiatric disorders or severe caffeine intolerance/allergy
  • Use of medications affecting caffeine metabolism or muscle anabolism (e.g., beta-blockers, antidepressants, anabolic steroids)
  • Musculoskeletal injuries that prevent safe resistance training
  • Smoking or alcohol consumption at levels that could affect study outcomes
  • Concurrent participation in another exercise intervention study
  • Inability to tolerate DXA scanning or blood sampling

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpasa, Faculty of Sport Sciences Performance Laboratory

    Istanbul, Avcilar, 34010

Other trials in Turkey (Türkiye)

About this study

Official title: Study of Different Caffeine Supplementation Strategies on Resistance Training-Induced Adaptations

This parallel-group, randomized, double-blind, placebo-controlled trial investigates the effects of three different caffeine supplementation strategies on resistance training-induced adaptations in 120 caffeine-naive, inactive young adult males. Participants will undergo a 10-week supervised resistance training program. The four supplementation strategies are: (1) constant daily low-moderate dosing (4 mg/kg/day), (2) gradually escalating dose (2 to 6 mg/kg across weeks), (3) training-day-only caffeine (4 mg/kg/day), and (4) placebo. Primary outcomes include maximal strength, body composition (lean body mass and fat mass), skeletal muscle thickness, and training volume progression. Secondary outcomes include muscular endurance, jump height, flight-time-to-contraction-time (FT:CT) ratio, mechanistic/biological variables (epinephrine, norepinephrine, cortisol, testosterone, creatine kinase, IGF-1), rate of perceived exertion, sleep/recovery parameters, and adverse effects.

Read the detailed description

BACKGROUND: Caffeine is a well-established acute ergogenic aid that reliably improves endurance, power, and resistance-exercise performance when consumed at typical ergogenic doses (approximately 2-6 mg/kg about 60 minutes pre-exercise). However, whether caffeine exerts direct biological effects on muscle protein balance and hypertrophy remains unclear. Regular caffeine ingestion produces partial physiological tolerance, creating the possibility that chronic supplementation elicits different outcomes than acute dosing. OBJECTIVES: This study addresses three translational questions: (1) Does constant daily low-moderate dosing potentiate training adaptations? (2) Does a gradually escalating dose strategy produce greater effects by overcoming tolerance? (3) Does training-day-only caffeine preserve acute ergogenic effects while limiting tolerance and sleep disturbance? METHODS: 120 caffeine-naive, physically inactive young adult males aged 18-30 years will be randomly assigned to one of the following groups (n=30 per group): (1) constant daily low-moderate dosing (CON, 4 mg/kg/day), (2) gradually escalating dose (ESC, 2 to 6 mg/kg across weeks), (3) training-day-only caffeine (TDO, 4 mg/kg/day), and (4) placebo (PLA). All participants will undergo supervised resistance training 3 times per week. OUTCOMES: Primary endpoints include maximal strength, body composition (lean body mass and fat mass), skeletal muscle thickness, and training volume metrics. Secondary outcomes include muscular endurance, jump height, flight-time-to-contraction-time (FT:CT) ratio, mechanistic/biological variables (epinephrine, norepinephrine, cortisol, testosterone, creatine kinase, IGF-1), rate of perceived exertion, sleep/recovery parameters, and adverse effects. STATISTICAL ANALYSIS: Linear Mixed Models will be used to analyze the data.

Being tested
Caffeine (Constant Daily Dose), Caffeine (Escalating Dose), Caffeine (Training Days Only), placebo capsule
Keywords
Caffeine, Resistance Training, Muscle Adaptation, Supplementation, Strength Training, Hypertrophy
Medical subject headings
Muscular Atrophy, Hypertrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caffeine (Constant Daily Dose)Dietary supplement

    Oral caffeine capsule at 4 mg/kg body weight, consumed daily approximately 60 minutes before training sessions (on training days) or at the same time of day (on rest days).

  • Caffeine (Escalating Dose)Dietary supplement

    • Oral caffeine starting at 2 mg/kg/day and increasing incrementally to reach 6 mg/kg/day by week 10.
  • Caffeine (Training Days Only)Dietary supplement

    Oral caffeine capsule at 4 mg/kg body weight, consumed only on training days approximately 60 minutes before exercise.

  • placebo capsuleDietary supplement

    Oral placebo capsule (250 mg cellulose), consumed daily approximately 60 minutes before training sessions (on training days) or at the same time of day (on rest days).

Study groups in NCT07410195
Study groupRoleWhat they receive
Strategy 1: Constant Daily DoseExperimentalParticipants receive caffeine at a constant daily dose of 4 mg/kg/day for 10 weeks. Supervised resistance training is performed 3 times per week for 10 weeks.
Receives: Dietary Supplement: Caffeine (Constant Daily Dose)
Strategy 2: Escalating DoseExperimentalParticipants receive caffeine at a gradually escalating dose, starting at 2 mg/kg/day in week 1 and increasing to 6 mg/kg/day by week 10 (1 mg/kg every 2 weeks). Supervised resistance training is performed 3 times per week for 10 weeks.
Receives: Dietary Supplement: Caffeine (Escalating Dose)
Strategy 3: Training Days OnlyExperimentalParticipants receive caffeine at 4 mg/kg only on training days (3 times per week) for 10 weeks. Supervised resistance training is performed 3 times per week for 10 weeks.
Receives: Dietary Supplement: Caffeine (Training Days Only)
PlaceboPlacebo comparatorParticipants receive 250 mg/day cellulose for 10 weeks. Supervised resistance training is performed 3 times per week for 10 weeks.
Receives: Dietary Supplement: placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Lean Body Mass Measured by DXA

    Change in total lean body mass measured using dual-energy X-ray absorptiometry (DXA), reported in kilograms.

    Measured: Baseline and post-test (after completing 10 weeks of interventions)

  2. Change in Fat Mass Measured by DXA

    Change in fat mass measured using DXA.

    Measured: Baseline and post-test (after completing 10 weeks of interventions)

  3. Maximal Strength

    Measure by one-repetition maximum (1-RM) on a lower body (Smith machine Back Squat) and two upper body (Bench Press machine and Lat Pulldown machine) exercises.

    Measured: Baseline, and post-test (after completing 10 weeks of interventions)

  4. Total Training Volume Load

    Total training volume load calculated as the sum of lifted load using the formula (kilograms × repetitions × sets) accumulated during each intervention period.

    Measured: During the intervention period (all training sessions).

  5. Change in Skeletal Muscle Thickness

    Change in skeletal muscle thickness measured using B-mode ultrasound, reported in mm.

    Measured: Baseline and post-test (after completing 10 weeks of interventions)

Secondary outcomes (13)
  1. Muscular endurance

    It will be measured by a repetitions-to-failure test on the Smith machine back squat using a load corresponding to 60% of the current 1RM.

    Measured: Baseline, and post-test (after completing 10 weeks of interventions)

  2. Neuromuscular function

    It will be measured by the countermovement jump (CMJ) test on a force platform.

    Measured: Baseline and post-test (after completing 10 weeks of interventions)

  3. Resting concentrations of testosterone

    They will be measured using standard biochemical analyses.

    Measured: Baseline, and post-test (after completing 10 weeks of interventions)

  4. Plasma epinephrine responses to exercise

    They will be measured using standard biochemical analyses.

    Measured: During the first training session of Week 1 and the final training session of Week 10, at three time points: (1) pre-supplementation, (2) immediately before exercise and (3) immediately after exercise.

  5. Recovery

    It will be assessed using the validated 0-10 Perceived Recovery Status Scale (0 to 2: very poorly recovered, 3 to 4: poorly recovered, 5 to 6: adequately recovered, 7 to 8: well recovered, and 9 to 10: fully recovered).

    Measured: Before each of the 30 training sessions during the study.

  6. Adverse Events

    Adverse events will be assessed using a standardized questionnaire administered throughout the study.

    Measured: From initiation of the 4-week caffeine abstinence period through completion of the post-intervention assessments, monitored throughout the study (approximately 16 weeks).

  7. Sleep quality

    It will be assessed by the Pittsburgh Sleep Quality Index (PSQI).

    Measured: Baseline and post-test (after completing 10 weeks of interventions).

  8. Rate of perceived exertion

    Assessed using the Borg Category-Ratio (CR10) Scale, ranging from 0 ("nothing at all") to 10 ("maximal"). Participants will report their perceived exertion after each supervised training session.

    Measured: After each supervised training session, participants were assessed throughout the 10-week intervention period (30 training sessions).

  9. Resting concentrations of insulin-like growth factor-1 (IGF-1)

    They will be measured using standard biochemical analyses.

    Measured: Baseline, and post-test (after completing 10 weeks of interventions)

  10. Resting concentrations of cortisol

    They will be measured using standard biochemical analyses.

    Measured: Baseline, and post-test (after completing 10 weeks of interventions)

  11. Resting concentrations of creatine kinase

    They will be measured using standard biochemical analyses.

    Measured: Baseline, and post-test (after completing 10 weeks of interventions)

  12. Serum cortisol responses to exercise

    They will be measured using standard biochemical analyses.

    Measured: During the first training session of Week 1 and the final training session of Week 10, at three time points: (1) pre-supplementation, (2) immediately before exercise and (3) immediately after exercise.

  13. Plasma norepinephrine responses to exercise

    They will be measured using standard biochemical analyses.

    Measured: During the first training session of Week 1 and the final training session of Week 10, at three time points: (1) pre-supplementation, (2) immediately before exercise and (3) immediately after exercise.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start20 Feb 2026
  3. Primary completion30 May 2026
  4. Study completion7 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a parallel-group, randomized, double-blind, placebo-controlled trial with four parallel supplementation strategies: (1) constant daily low-moderate dosing (4 mg/kg/day), (2) gradually escalating dose (2 to 6 mg/kg across weeks), (3) training-day-only caffeine (4 mg/kg/day), and (4) placebo. All participants undergo supervised resistance training three times per week.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07410195
Sponsor's protocol ID
2026/01-1792
Status last verified
Jul 2026
First submitted
30 Jan 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All extracted personal data (IPD) from this information will be shared along with supporting data for the publication results. Data dictionaries relating to data settings are also stored.

Publications

  • Lovallo WR, Whitsett TL, al'Absi M, Sung BH, Vincent AS, Wilson MF. Caffeine stimulation of cortisol secretion across the waking hours in relation to caffeine intake levels. Psychosom Med. 2005 Sep-Oct;67(5):734-9. doi: 10.1097/01.psy.0000181270.20036.06.

    PubMed 16204431
  • Matsumura T, Takamura Y, Fukuzawa K, Nakagawa K, Nonoyama S, Tomoo K, Tsukamoto H, Shinohara Y, Iemitsu M, Nagano A, Isaka T, Hashimoto T. Ergogenic Effects of Very Low to Moderate Doses of Caffeine on Vertical Jump Performance. Int J Sport Nutr Exerc Metab. 2023 Jul 26;33(5):275-281. doi: 10.1123/ijsnem.2023-0061. Print 2023 Sep 1.

    PubMed 37414404
  • Brook MS, Wilkinson DJ, Mitchell WK, Lund JN, Szewczyk NJ, Greenhaff PL, Smith K, Atherton PJ. Skeletal muscle hypertrophy adaptations predominate in the early stages of resistance exercise training, matching deuterium oxide-derived measures of muscle protein synthesis and mechanistic target of rapamycin complex 1 signaling. FASEB J. 2015 Nov;29(11):4485-96. doi: 10.1096/fj.15-273755. Epub 2015 Jul 13.

    PubMed 26169934
  • Pickering C, Kiely J. Are low doses of caffeine as ergogenic as higher doses? A critical review highlighting the need for comparison with current best practice in caffeine research. Nutrition. 2019 Nov-Dec;67-68:110535. doi: 10.1016/j.nut.2019.06.016. Epub 2019 Jun 26.

    PubMed 31400738
  • Grgic J, Trexler ET, Lazinica B, Pedisic Z. Effects of caffeine intake on muscle strength and power: a systematic review and meta-analysis. J Int Soc Sports Nutr. 2018 Mar 5;15:11. doi: 10.1186/s12970-018-0216-0. eCollection 2018.

    PubMed 29527137
  • Guest NS, VanDusseldorp TA, Nelson MT, Grgic J, Schoenfeld BJ, Jenkins NDM, Arent SM, Antonio J, Stout JR, Trexler ET, Smith-Ryan AE, Goldstein ER, Kalman DS, Campbell BI. International society of sports nutrition position stand: caffeine and exercise performance. J Int Soc Sports Nutr. 2021 Jan 2;18(1):1. doi: 10.1186/s12970-020-00383-4.

    PubMed 33388079
  • Grgic J, Grgic I, Pickering C, Schoenfeld BJ, Bishop DJ, Pedisic Z. Wake up and smell the coffee: caffeine supplementation and exercise performance-an umbrella review of 21 published meta-analyses. Br J Sports Med. 2020 Jun;54(11):681-688. doi: 10.1136/bjsports-2018-100278. Epub 2019 Mar 29.

    PubMed 30926628

Questions about this trial

What is this clinical trial studying?

A study testing Caffeine (Constant Daily Dose), Caffeine (Escalating Dose) and Caffeine (Training Days Only) in people with Muscle Hypotrophy and Exercise Performance, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lean Body Mass Measured by DXA (time frame: Baseline and post-test (after completing 10 weeks of interventions)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07410195, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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