Creatine Supplementation and Resistance Training in Premenopausal Females

Sponsor
University of Idaho (Other)
Overall Status
Recruiting
CT.gov ID
NCT05745870
Collaborator
(none)
30
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2
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Study Details

Study Description

Brief Summary

The goal of this clinical trial is to determine the effects of creatine monohydrate and resistance training on lean mass, sleep, muscular strength, and perceived menstrual cycle symptoms in untrained premenopausal females. The main questions it aims to answer are: 1) Does creatine monohydrate supplementation improve body composition, muscular strength, and sleep? 2) Does creatine monohydrate decrease perceived menstrual cycle symptoms compared to a placebo control?

Participants will be asked to consume creatine monohydrate daily for 42 consecutive days and well as perform a daily ovulation test. Pre and post testing will include assessments of urine specific gravity to determine hydration status, body composition testing, muscular strength testing and questionnaires.

Researchers will compare creatine monohydrate supplementation to a maltodextrin control to see if body composition, sleep, muscular strength, and perceived menstrual cycle symptoms are improved following 6-weeks.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Creatine Monohydrate Supplementation
Phase 1

Detailed Description

This study will be a 6 week creatine monohydrate and resistance training intervention with performance familiarization and pre and post testing. Participants will report to the Human Performance Laboratory (HPL), having fasted from alcohol, caffeine, and exercise for a minimum of 12-hours, for pre testing and to sign an informed consent explaining the procedures and potential risks and benefits of participation. Participants will then provide one urine sample to determine proper hydration status for body composition assessment. Next, participants will complete a physical activity readiness questionnaire (PARQ+) prior to performing any physical tasks. Participants will complete a daily menstrual cycle log, fatigue questionnaire, and health history survey. Prior to body composition testing, participants will complete a dual-energy x-ray apsorptiometry (DXA) scan consent for to ensure absence of pregnancy. Then, a full-body DXA scan will be completed along with an InBody bioelectrical impedance analysis. Following body composition testing, participants will be fitted for an Oura ring to track their sleep. Lastly, muscular strength will be assessed using the Tonal. Following a 5-minute full-body warm up, 1-repetition maximum will be determined using two upper body and two lower body exercises at maximal effort. Upon conclusion of pre-testing, participants will be randomized into two groups: 1) creatine monohydrate (5g/d creatine monohydrate + 5g/d maltodextrin) or 2) placebo (10 g/d maltodextrin) for 42 consecutive days. Participants will visit the HPL daily to consume their respective supplement as well as provide a urine sample for ovulation status determination. Additionally, participants will complete two resistance training sessions on non-consecutive days using the Tonal per week for 6-weeks. Following 6-weeks, post-testing will occur and includes the same procedures as pre-testing.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Creatine Supplementation and Resistance Training on Lean Mass, Sleep, Muscular Strength, and Perceived Menstrual Cycle Symptoms in Premenopausal Females
Actual Study Start Date :
Jan 20, 2023
Anticipated Primary Completion Date :
May 12, 2023
Anticipated Study Completion Date :
May 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Creatine Monohydrate Supplementation

Participants will consume 5g/d creatine monohydrate + 5g/d maltodextrin for 42 consecutive days

Dietary Supplement: Creatine Monohydrate Supplementation
Participants will consume 5g/d creatine monohydrate + 5g/d maltodextrin for 42 consecutive days

Placebo Comparator: Placebo Supplementation

Participants will consume 10g/d maltodextrin for 42 consecutive days

Dietary Supplement: Creatine Monohydrate Supplementation
Participants will consume 5g/d creatine monohydrate + 5g/d maltodextrin for 42 consecutive days

Outcome Measures

Primary Outcome Measures

  1. Body Composition [42 days]

    Change in lean mass (kg, %) using a DXA scan from baseline after 42 days

  2. Sleep [42 days]

    Change in sleep (hours, minutes, REM) using the Oura Ring application tracking from baseline after 42 days

  3. Muscular Strength [42 days]

    Change in muscular strength (1-repetition maximum) using the Tonal from baseline after 42 days

  4. Perceived Menstrual Cycle Symptoms [42 days]

    Change in perceived menstrual cycle symptoms (fatigue, cramping, bloating) using menstrual cycle questionnaires from baseline after 42 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 22 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • premenopausal females 18-25 yrs

  • able to resistance train with no contraindications to exercise testing

Exclusion Criteria:
  • premenopausal female taking hormonal contraceptives

  • premenopausal females who are resistance training >2x/wk

  • premenopausal females who consume creatine monohydrate

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Idaho Moscow Idaho United States 83844

Sponsors and Collaborators

  • University of Idaho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ann Brown, Associate Professor, University of Idaho
ClinicalTrials.gov Identifier:
NCT05745870
Other Study ID Numbers:
  • 21-170
First Posted:
Feb 27, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Ann Brown, Associate Professor, University of Idaho

Study Results

No Results Posted as of Feb 27, 2023