Muscle AtrophyProteinNCT07843095
Protein Supplementation During Luteal Phase to Stop Protein Degradation
A study testing protein supplement in people with Muscle Atrophy, run by Sam Houston State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy
- What is being tested?
- protein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2026to 29 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eumenorrheic
- 18 to 35 years old
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Damian Chiandussi, MD contact
United States2 sites, 2 recruiting
- Recruiting
SHSU College of Osteopathic Medicine
Conroe, Texas, 77304
Kyndal Kutac, 979-743-1135, kbk016@shsu.edu
Damian Chiandussi, MD, 936-202-5279, dac150@shsu.edu
- Not yet recruiting
SHSU Physician's Clinic
Conroe, Texas, 77304
Kyndal Kutac, 979-743-1135, kbk016@shsu.edu
Damian Chiandussi, MD, 936-202-5279, dac150@shsu.edu
About this study
Official title: Protein Supplementation During 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. 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.
Read the detailed description
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.
- Conditions
- Muscle Atrophy
- Being tested
- protein supplement, Placebo
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementDietary supplement
Also called A
Protein supplementation during progesterone peak to stop protein degradation effect.
PlaceboDietary supplement
Also called B
Will receive placebo supplementation
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Will receive protein supplement Receives: Dietary Supplement: protein supplement |
| B | Placebo comparator | Will receive placebo supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Protein Degradation
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.
Measured: 48 hours
Secondary outcomes (1)
Decrease protein degradation
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start4 Aug 2026
- Primary completion17 Dec 2026 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sam Houston State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Davis, PhD, Principal investigator, SHSU COM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843095
- Sponsor's protocol ID
- IRB-2026-259
- Acronym
- Protein
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gruber, C. J., Tschugguel, W., Schneeberger, C., & Huber, J. C. (2002). Production and Actions of Estrogens. New England Journal of Medicine, 346, 340-352. https://doi.org/10.1056/nejmra000471 Taraborrelli, S. (2015). Physiology, production and action of progesterone. In Acta Obstetricia et Gynecologica Scandinavica (Vol. 94, pp. 8-16). Taylor and Francis Ltd. https://doi.org/10.1111/aogs.12771 Sims, S. T., Kerksick, C. M., Smith-Ryan, A. E., Janse de Jonge, X. A. K., Hirsch, K. R., Arent, S. M., Hewlings, S. J., Kleiner, S. M., Bustillo, E., Tartar, J. L., Starratt, V. G., Kreider, R. B., Greenwalt, C., Rentería, L. I., Ormsbee, M. J., VanDusseldorp, T. A., Campbell, B. I., Kalman, D. S., & Antonio, J. (2023). International society of sports nutrition position stand: nutritional concerns of the female athlete. Journal of the International Society of Sports Nutrition, 20(1). https://doi.org/10.1080/15502783.2023.2204066 Faustmann, G., Meinitzer, A., Magnes, C., Tiran, B., Obermayer-Pietsch, B., Gruber, H. J., Ribalta, J., Rock, E., Roob, J. M., & Winklhofer-Roob, B. M. (2018). Progesterone-associated arginine decline at luteal phase of menstrual cycle and associations with related amino acids and nuclear factor kB activation. PLoS ONE, 13(7). https://doi.org/10.1371/journal.pone.0200489 Draper, C. F., Duisters, K., Weger, B., Chakrabarti, A., Harms, A. C., Brennan, L., Hankemeier, T., Goulet, L., Konz, T., Martin, F. P., Moco, S., & van der Greef, J. (2018). Menstrual cycle rhythmicity: metabolic patterns in healthy women. Scientific Reports, 8. https://doi.org/10.1038/s41598-018-32647-0
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Supplementation During Luteal Phase
- ClinicalTrials.gov ID
- NCT07843095
- Acronym / sponsor ID
- Protein / IRB-2026-259
- Conditions
- Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Sam Houston State UniversityUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: protein supplementWill receive protein supplement |
| B | Placebo comparator | Dietary Supplement: PlaceboWill receive placebo supplement |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Eumenorrheic
- 18 to 35 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein supplementAlso: AProtein supplementation during progesterone peak to stop protein degradation effect. | Dietary supplement | A |
| PlaceboAlso: BWill receive placebo supplementation | Dietary supplement | B |
Primary outcome
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.
1 secondary outcome
Decrease protein degradation
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- BackgroundGruber, C. J., Tschugguel, W., Schneeberger, C., & Huber, J. C. (2002). Production and Actions of Estrogens. New England Journal of Medicine, 346, 340-352. https://doi.org/10.1056/nejmra000471 Taraborrelli, S. (2015). Physiology, production and action of progesterone. In Acta Obstetricia et Gynecologica Scandinavica (Vol. 94, pp. 8-16). Taylor and Francis Ltd. https://doi.org/10.1111/aogs.12771 Sims, S. T., Kerksick, C. M., Smith-Ryan, A. E., Janse de Jonge, X. A. K., Hirsch, K. R., Arent, S. M., Hewlings, S. J., Kleiner, S. M., Bustillo, E., Tartar, J. L., Starratt, V. G., Kreider, R. B., Greenwalt, C., Rentería, L. I., Ormsbee, M. J., VanDusseldorp, T. A., Campbell, B. I., Kalman, D. S., & Antonio, J. (2023). International society of sports nutrition position stand: nutritional concerns of the female athlete. Journal of the International Society of Sports Nutrition, 20(1). https://doi.org/10.1080/15502783.2023.2204066 Faustmann, G., Meinitzer, A., Magnes, C., Tiran, B., Obermayer-Pietsch, B., Gruber, H. J., Ribalta, J., Rock, E., Roob, J. M., & Winklhofer-Roob, B. M. (2018). Progesterone-associated arginine decline at luteal phase of menstrual cycle and associations with related amino acids and nuclear factor kB activation. PLoS ONE, 13(7). https://doi.org/10.1371/journal.pone.0200489 Draper, C. F., Duisters, K., Weger, B., Chakrabarti, A., Harms, A. C., Brennan, L., Hankemeier, T., Goulet, L., Konz, T., Martin, F. P., Moco, S., & van der Greef, J. (2018). Menstrual cycle rhythmicity: metabolic patterns in healthy women. Scientific Reports, 8. https://doi.org/10.1038/s41598-018-32647-0
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damian Chiandussi, MD contact
Patrick Davis, PhD principal investigator
SHSU COM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein supplement in people with Muscle Atrophy, run by Sam Houston State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyndal Kutac (979-743-1135, kbk016@shsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Protein Degradation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07843095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.