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临床试验/NCT07843095
NCT07843095招募中不适用

Protein Supplementation During Luteal Phase

Sam Houston State University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年8月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
34
试验地点
2
主要终点
Skeletal Muscle Protein Degradation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Eumenorrheic
  • •18 to 35 years old

排除标准

  • •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.

研究组 & 干预措施

A

Active Comparator

Will receive protein supplement

干预措施: protein supplement (Dietary Supplement)

B

Placebo Comparator

Will receive placebo supplement

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Skeletal Muscle Protein Degradation

时间窗: 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.

次要结局

  • Decrease protein degradation(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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