15 Participants NeededMy employer runs this trial

Phenylalanine Intake for Menstruation

RE
PD
Overseen ByPaloma DeLisle
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the phenylalanine requirements of women during their menstrual cycle. Current recommendations, based on studies with men, may not account for women's hormonal changes. Researchers will use a simple breath test and special diets to determine the appropriate amount of phenylalanine for healthy women. Women with regular menstrual cycles, not using hormonal birth control, and free from certain health conditions may qualify. As an unphased study, this trial provides a unique opportunity to contribute to research that could lead to more personalized dietary recommendations for women.

Will I have to stop taking my current medications?

If your current medications affect normal body metabolism, you would not be eligible to participate in this trial. The study requires participants to be free from medications that alter metabolism.

What prior data suggests that this technique is safe for menstruating females?

Research has shown that phenylalanine, an essential dietary component, is generally safe. It must be obtained from food. Studies have employed simple, non-invasive methods to assess its safety for women at various stages of their menstrual cycle.

Although specific safety data for this study is not available, phenylalanine is commonly consumed as part of a regular diet, suggesting it is generally safe for most people when consumed in normal amounts. No major side effects have been reported from phenylalanine in typical use or in past studies on similar amino acids, which supports its safety in the trial.12345

Why are researchers excited about this trial?

Unlike standard treatments for menstruation issues, which often involve hormonal therapies or pain relief medications, phenylalanine intake is being explored for its potential dietary benefits. Phenylalanine, an amino acid, is unique because it might help in managing menstrual symptoms by modulating neurotransmitter levels, offering a non-drug alternative with possibly fewer side effects. Researchers are excited about this approach because it targets menstrual symptoms through nutritional adjustments, which could offer personalized and potentially safer management options.

What evidence suggests that phenylalanine intake might be effective for menstruation?

Research has shown that phenylalanine levels can change during different stages of the menstrual cycle. Studies have found these changes to be significant, especially for individuals with phenylketonuria, a condition affecting phenylalanine processing. Although the intake of phenylalanine and other nutrients remains relatively stable across menstrual phases, the body's processing of them can vary. This trial will test various phenylalanine intakes, from deficient to excess, to determine how phenylalanine needs might require adjustment based on the menstrual cycle. Understanding these changes could lead to improved dietary guidelines for menstruating women.16789

Are You a Good Fit for This Trial?

This trial is for healthy women aged 20-35 who have had regular menstrual cycles (21-35 days) for the past year, a BMI between 18 and 28, and no pre-existing health conditions.

Inclusion Criteria

I currently have regular menstrual periods.
I am between 20 and 35 years old.
* Regular menstrual cycle (21-35 day cycle) for the past 12 months
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants are studied during the luteal and follicular phases with varying phenylalanine intakes

14 weeks
Up to 7 visits per menstrual phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Phenylalanine

Trial Overview

The study tests how much phenylalanine (an essential amino acid from food) women need during different phases of their menstrual cycle. Participants will follow specific diets and provide breath samples using a safe, non-invasive method.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Test Phenylalanine IntakeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Citations

The influence of menstrual cycle on metabolic control and diet ...

Protein, phenylalanine and calorie intake was not significantly different between the phases of the menstrual cycle phase (follicular or luteal) ...

The relationship between menstrual cycle characteristics ...

Adherence to diet was lost in 7 patients (9.4 %) during the menstrual periods. 21.7 % of the patients were able to consume the entire amount of the Phe-free ...

Dietary restraint and menstrual cycle phase modulated l ...

Data from 20 women and 32 menstrual cycles were analyzed. Daily energy intake was suppressed by 9% for Phe compared to control and 8% in the follicular versus ...

Phenylalanine Requirements in the Menstrual Phases

This clinical study aims to determine the dietary phenylalanine requirement in females to help set nutrition guidelines for females that heavily consider the ...

Phenylalanine Intake for Menstruation

The aim of this study is to find phenylalanine requirement for healthy, menstruating females. An innovative, non-invasive technique utilizing pre-determined ...

Phenylalanine Requirements in the Menstrual Phases

The aim of this study is to find phenylalanine requirement for healthy, menstruating females. An innovative, non-invasive technique utilizing pre-determined ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40653469/

The influence of menstrual cycle on metabolic control and ...

Based on this cohort, we found a significant correlation between the phases of the menstrual cycle and Phe concentration, with the lowest ...

The Relationship Between Menstrual Cycle Characteristics ...

Menorrhagia and dysmenorrhea was observed in 6.7% and 71.6% respectively. Adherence to diet was lost in 7 patients during the menstrual period.

Decreased amino acid availability across the menstrual ...

Interestingly, the only amino acids that were not significantly lower during the ML phase were phenylalanine and leucine, and the latter, is thought to be the ...