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NCT Number: NCT07843095

Protein Supplementation During Luteal Phase to Stop Protein Degradation

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SHSU College of Osteopathic Medicine, Conroe, Texas, United States

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About this study

The physiologic effects of the female menstrual cycle have been shown to cause many changes to metabolic processes throughout the body depending on the phase of the cycle. For example, during the follicular phase, increase in estrogen aids in arterial vasodilation, lipid metabolism, neuroprotection, and maintaining bone density (Gruber et al. 2002). During the luteal phase, the increase in progesterone aids in thermoregulation, increased respiration, and basal insulin levels (Taraborrelli 2015). However, there is conflicting evidence regarding net progesterone effects on skeletal muscle. Some studies state that progesterone has an anabolic effect while others suggest the contrary. Despite the discrepancies with current literature, Sims et al. recommends female athletes increase their protein intake by 12% during the luteal phase of their menstrual cycle to potentially counteract the protein catabolic effects of progesterone on skeletal muscle (2023). The basis of this conclusion was based on invitro and in vivo studies showing decreases amino acids during the luteal phase (Faustmann et al. 2018 & Draper et al. 2018)

To our knowledge, no study exists that analyzes protein degradation with protein supplementation increase during the luteal phase. 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. This research could help determine if millions of women would benefit from additional protein supplementation during the luteal phase, which may lead to decreased skeletal muscle atrophy over time. We anticipate there will be an advantageous, decreased catabolic effect with increasing protein intake during the luteal phase.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protein Supplement

Dietary Supplement

Protein supplementation during progesterone peak to stop protein degradation effect.

Other names: A

Placebo

Dietary Supplement

Will receive placebo supplementation

Other names: B

Primary outcomes

  1. Skeletal Muscle Protein Degradation

    Time frame: 48 hours

    Primary outcomes will be changes in urinary N-fragment of titin and serum 3-methylhistidine between supplementation and placebo conditions. Paired t-tests or linear mixed-effects models will be used to account for within-subject crossover effects. Hormone levels will be included as covariates. Statistical significance will be set at p < 0.05.

Secondary outcomes

  1. Decrease protein degradation

    Time frame: 48 hours

    We would like to home in on protein intake and degradation to quantify the amount of protein loss seen during the luteal phase, the point at which protein degradation is deemed to be the highest. Our specific aims for this project will be to 1) quantify protein degradation at the time of the luteal phase and 2) determine whether targeted protein supplementation during the luteal phase will reduce measured protein degradation. We anticipate there will be an advantageous, decreased catabolic effect with increasing protein intake during the luteal phase.

    To measure this, we will use Blood and Urine samples during the menstrual cycle.

    Blood Samples:

    Blood will be collected in serum separator tubes (SST)

    Serum will be analyzed using enzyme-linked immunosorbent assay (ELISA) methods to measure:

    3-Methylhistidine Progesterone

    Urine Samples:

    Urine samples will be analyzed using ELISA methods to measure:

    N-fragment of Titin Creatin

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Sam Houston State University

Other

Registry information

Official study title

Protein Supplementation During Luteal Phase

Acronym: Protein

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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