NCT07843095 · Sam Houston State University
Protein Supplementation During Luteal Phase to Stop Protein Degradation
(Protein)
What this study is about
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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
protein supplement
Protein supplementation during progesterone peak to stop protein degradation effect.
DIETARY_SUPPLEMENT
Placebo
Will receive placebo supplementation
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Conroe, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations