Postprandial Triglyceride Concentrations Across Menstrual Cycle Phases

Официальное название

Effect of Menstrual Cycle Phases on Postprandial Triglyceride Concentrations in Healthy Premenopausal Females: A Crossover Study

Обзор

The goal of this clinical trial is to investigate the effect of menstrual cycle phases on postprandial triglyceride concentrations in healthy young female adults. The main question it aims to answer is: do postprandial triglyceride concentrations differ between the follicular and luteal phases of the menstrual cycle? Participants will: visit the laboratory for a preliminary screening session to assess eligibility, and undergo two experimental sessions consisting of six hours of seated rest following the consumption of a high-fat meal (one session conducted in the early follicular phase, and one session conducted in the mid-luteal phase of the menstrual cycle).

Вмешательства

• Другое Early Follicular Phase
  In the early follicular phase of the menstrual cycle, participants will undergo 6 hours of seated rest after the consumption of a high-fat meal representing 33% of estimated daily energy expenditure and consisting of 59% of calories from fat.
• Другое Mid-Luteal Phase
  In the mid-luteal phase of the menstrual cycle, participants will undergo 6 hours of seated rest after the consumption of a high-fat meal representing 33% of estimated daily energy expenditure and consisting of 59% of calories from fat.

Первичные конечные точки

• Change from baseline in plasma total triglyceride concentrations [Срок оценки: 6 hours]
• Change from baseline in plasma buoyant triglyceride concentrations [Срок оценки: 6 hours]
• Change from baseline in plasma denser triglyceride concentrations [Срок оценки: 6 hours]
• Change from baseline in plasma non-esterified fatty acid concentrations [Срок оценки: 6 hours]
• Change from baseline in plasma insulin concentrations [Срок оценки: 6 hours]
• Change from baseline in plasma glucose concentrations [Срок оценки: 6 hours]
• Change from baseline in plasma β-hydroxybutyrate concentrations [Срок оценки: 6 hours]

Вторичные конечные точки (11)

• Baseline serum β-estradiol concentrations [Срок оценки: Baseline]
• Baseline serum progesterone concentrations [Срок оценки: Baseline]
• Fasting resting energy expenditure [Срок оценки: Baseline]
• Change from baseline in respiratory exchange ratio [Срок оценки: 6 hours]
• Change from baseline in desire to eat [Срок оценки: 6 hours]
• Change from baseline in hunger [Срок оценки: 6 hours]
• Change from baseline in fullness [Срок оценки: 6 hours]
• Change from baseline in prospective food consumption [Срок оценки: 6 hours]
• Change from baseline in resting energy expenditure [Срок оценки: 6 hours]
• Change from baseline in carbohydrate oxidation rate [Срок оценки: 6 hours]
• Change from baseline in lipid oxidation rate [Срок оценки: 6 hours]

Критерии участия

Критерии включения

• English or French speaking
• Ability to provide informed consent

Критерии исключения

• History or evidence of chronic disease
• Current use of hypolipemic medication
• Current use of hormonal contraceptives
• Current use of antidepressants
• Current use of anticoagulants
• Ongoing smoking status
• Experiencing pregnancy, puerperium, or irregular menstrual cycles

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Канада · 1 центр

• Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Scien — Ottawa

Идентификаторы

NCT: NCT07459465 · H-06-18-837-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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