Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533501
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Leucine Requirements During the Menstrual Cycle
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Leucine Requirements During Different Phases of the Menstrual Cycle in Eumenorrheic Women
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The existing guidelines for dietary amino acid intake for women are set the same as those established for men These recommendations might not be appropriate for women as they do not take into consideration important differences between male and female physiology like the menstrual cycle This study aims to determine the leucine requirements during the phases of the menstrual cycle Leucine is an essential amino acid cannot be made naturally in the body and is necessary for protein synthesis and other important cellular functions Consuming an adequate amount daily is crucial for maintaining overall health An innovative non-invasive technique utilizing pre-determined diets safe stable isotopes and a simple breath collection method will be used Previous work done by Elango Lab investigators has applied this method to investigate other amino acids in pregnant non-pregnant and lactating women
Detailed Description:
The objective of the study is to determine leucine requirements using the indicator amino acid oxidation method during the follicular phase and the luteal phase of the menstrual cycle in healthy women between the ages of 20-35 yIn comprehending protein needs and achieving protein targets it is imperative to establish individual amino acid requirements This clinical study aims to determine the dietary requirements of leucine for women helping build a strong foundation for setting dietary guidelines for women The existing values derived from guidelines designed for men overlook the crucial impact of the menstrual cycle on energy and dietary intake Relying on amino acid requirements derived from studies in men for women significantly heightens the risk of potential harm It is crucial to identify the distinct amino acid requirements for women and grasp how these needs are affected by various phases of the menstrual cycle A minimum of 15 healthy women 20-35 y will be recruited and studied at two menstrual phases over a range of test leucine intakes 10 20 30 40 55 70 and 85 mgkgday Women will be invited to participate in up to 7 study daysphase and randomized to a different intake at each study day Participants eligibility will be assessed during a pre-study day The goal is to study a minimum of 7 women at each intake for a total of 49 study days in each stage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None