Image

Phenylalanine Requirements in the Menstrual Phases

Phenylalanine Requirements in the Menstrual Phases

Recruiting
20-35 years
Female
Phase N/A

Powered by AI

Overview

Phenylalanine is an essential amino acid that must be obtained through food. Current adult phenylalanine recommendation is based on male-conducted studies and set the same for females. These recommendations may not be appropriate for females, as they do not take into consideration the hormonal changes over the menstrual cycle. The menstrual cycle is a rhythmic hormonal process split into two phases, with hormones regulating metabolism differently. The aim of this study is to find phenylalanine requirement for healthy, menstruating females. 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 females as well as in children.

Description

The objective of this study is to assess phenylalanine requirements in healthy, menstruating females, between the ages 20-35, during the luteal and follicular phases using the minimally invasive indicator amino acid oxidation method.

In comprehending protein needs and achieving protein targets, it is imperative to establish individual amino acid requirements. This clinical study aims to determine the dietary phenylalanine requirement in females to help set nutrition guidelines for females that heavily consider the metabolic and hormonal effects of the differences between the menstrual cycle phases. The existing values, derived from guidelines designed for males, overlook the crucial impact of the menstrual cycle on energy and dietary intake. Relying on amino acid requirements derived from studies in males for females significantly heightens the risk of potential harm. It is crucial to identify the distinct amino acid requirements for females and grasp how these needs are affected by various phases of the menstrual cycle. A minimum of 15 healthy females (20-35 y) will be recruited and studied at two menstrual phases over a range of test phenylalanine intakes (2.5, 5, 7.5 10, 12.5 17.5, and 22.5 mg/kg/day). Subjects will be invited to participate in up to 7 study days/phase 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 participants at each intake, for a total of 49 study days in each stage.

Eligibility

Inclusion Criteria:

  • People with menstrual cycles
  • Between the ages of 20 to 35y
  • Regular menstrual cycle (21-35 day cycle) for the past 12 months
  • Body mass index (BMI) of between 18 and 28 kg/m2
  • Free from pre-existing health conditions

Exclusion Criteria:

  • People who are currently using hormonal birth control or any contraceptive that would affect sex hormones
  • People on hormone therapy
  • People with an abnormal menstrual cycle history
  • People with non-traditional dietary practices
  • Recent weight loss/weight gain
  • People with a history of endocrine disorders
  • People who are pregnant
  • People who are breastfeeding
  • People who have given birth in the last 18 months
  • People who depend on medication that affects normal metabolism. Any medication that alters normal body metabolism would skew the results and compromise the validity of the data set.
  • People with a metabolic, neurological, genetic, or immune disorder likely to affect nutritional requirements or overall body metabolism.

Study details
    Menstrual Cycle

NCT07481201

University of British Columbia

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.