Recruiting

Protein Supplementation

Sponsor:

Sam Houston State University

Code:

NCT07843095

Conditions

Muscle Atrophy

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

protein supplement

Placebo

Study Details

Brief summary:

The purpose of this research is to determine if increasing 12% of daily protein intake during the luteal phase mitigates the potential catabolic effects of progesterone on skeletal muscle. We anticipate there will be an advantageous, decreased catabolic effect with increasing protein intake during the luteal phase.

By doing this study, we hope to learn if millions of women would benefit from additional protein supplementation during the luteal phase, which may lead to decreased skeletal muscle atrophy over time. Your participation in this research will last about 4 months.

Conditions

Muscle Atrophy

Study ID

NCT07843095

Start date

Aug 4, 2026

Status verified date

Apr, 2026

Completion date

Jan 29, 2027

Anticipated

Primary completion date

Dec 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Eumenorrheic
  • 18 to 35 years old

Exclusion Criteria:

  • Pregnant or lactating (These individuals will not have a regular menstrual cycle) in the previous six months
  • Vegetarian (protein supplementation is from animal origin)
  • Contraceptive use, any hormone based contraceptive use for 6 months prior to enrollment
  • Use of illicit drugs in previous 6 months.
  • Non-tobacco user
  • Gasterointestinal disorders, liver disease, infectious disease, cardiovascular, pulmonary, renal, immune, metabolic, cancer
  • Medications: corticosteroids, chronic NSAIDS, high strength acne, testosterone
  • Diagonsed PCOS, endometrosis, ovarian insufficency, or other menstrual cycle disorder.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: A

Will receive protein supplement

placebo comparator: B

Will receive placebo supplement

Interventions

protein supplement

Protein supplementation during progesterone peak to stop protein degradation effect.

Placebo

Will receive placebo supplementation

Primary outcome measure

  • Skeletal Muscle Protein Degradation [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Kyndal Kutac

979-743-1135kbk016@shsu.edu

Damian Chiandussi, MD

dac150@shsu.edu

Locations

SHSU College of Osteopathic Medicine

Recruiting

Conroe, Texas, United States, 77304

Contacts

Kyndal Kutac

979-743-1135kbk016@shsu.edu

Damian Chiandussi, MD

936-202-5279dac150@shsu.edu

Principal Investigator:

Patrick Davis, PhD

More Information

Sponsor

Sam Houston State University

Last update posted

Sep 25, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Sam Houston State University on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.