Creatine Supplementation and Resistance Training in Premenopausal Females

NCT05745870 | Completed Phase 1 FDA Drug

• 1 other identifier: 21-170
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

Creatine monohydrate; resistance training; menstrual cycle; female physiology; body composition

Outcome Measures

Primary Outcomes (4)

• Body Composition

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

  42 days

• Sleep

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

  42 days

• Muscular Strength

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

  42 days

• Perceived Menstrual Cycle Symptoms

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

  42 days

Study Arms (2)

Creatine Monohydrate Supplementation

EXPERIMENTAL

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

Dietary Supplement: Creatine Monohydrate Supplementation

Placebo Supplementation

PLACEBO COMPARATOR

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

Dietary Supplement: Creatine Monohydrate Supplementation

Interventions

Creatine Monohydrate Supplementation DIETARY_SUPPLEMENT

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

Creatine Monohydrate Supplementation; Placebo Supplementation

Eligibility Criteria

• Age: 18 Years - 22 Years
• Gender Eligibility Details: Premenopausal female not taking contraceptives
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• premenopausal females 18-25 yrs
• able to resistance train with no contraindications to exercise testing

You may not qualify if:

• premenopausal female taking hormonal contraceptives
• premenopausal females who are resistance training \>2x/wk
• premenopausal females who consume creatine monohydrate

Sponsors & Collaborators

• University of Idaho: lead

Study Sites (1)

University of Idaho

Moscow, Idaho, 83844, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 27, 2023
• Study Start: January 20, 2023
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)