Health TrialsbyHealthPanel

Protein Supplementation During Luteal Phase to Stop Protein Degradation

ConditionMuscle Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorSam Houston State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Eumenorrheic

18 to 35 years old

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • protein supplement

    Dietary supplement

    Protein supplementation during progesterone peak to stop protein degradation effect.

  • Placebo

    Dietary supplement

    Will receive placebo supplementation

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: AActive comparator 1 intervention
Group B: BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sam Houston State University

Lead sponsor

Source ClinicalTrials.gov
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