Status:

RECRUITING

Appetite and Dietary Intake Across the Menstrual Cycle

Lead Sponsor:

University of British Columbia

Conditions:

Appetitive Behavior

Healthy

Eligibility:

FEMALE

18-35 years

Brief Summary

Lay language summary: Women are younger and menstruating about monthly ("pre-menopausal") often have fluctuations in the food they eat ("dietary intake") across the menstrual cycle. However, relations...

Detailed Description

Energy balance parameters (dietary intake and energy expenditure) are influenced by gonadal hormones, such as estradiol and progesterone that fluctuate across the menstrual cycle in pre-menopausal wom...

Eligibility Criteria

Inclusion Criteria:

  • Female sex

  • Age: 18 - 35 years

  • Nulliparous

  • Body mass index (BMI): 18.5 - 24.9 kg/m2

  • Premenopausal, with regular menstrual cycle (every 21-38 days, by self-report)

  • Sedentary or recreationally active, defined as: <300 minutes per week of voluntary exercise at moderate intensity or greater over the past 12 weeks

  • Not currently pregnant or lactating, not planning to become pregnant in the next 12 weeks

  • Ability and willingness to fast for 12 hours before each study day visit

  • If applicable:

    • For people who occasionally (i.e., <1x/day) use cannabis (including cannabidiol-based products): ability and willingness to abstain from cannabis for two days prior to each study day visit, the day of each study visit, and during each ad libitum diet phase.
    • For people who use cannabis daily: ability and willingness to continue to use the exact same amount of cannabis as they normally use for two days prior to each study day visit, the day of each study visit, and during each ad libitum diet phase.

Exclusion Criteria:

  • Current or previous major comorbidities, by self-report, including:

    • Cardiovascular diseases
    • Diabetes (type 1 or type 2)
    • Cancer
    • Thyroid diseases
    • Human immunodeficiency virus or hepatitis B or C
    • Renal diseases
    • Hepatic diseases
    • Polycystic ovary syndrome
  • Uncontrolled/untreated (self-report):

    • Hypertension (or measured diastolic blood pressure > 100 mm HG or systolic blood pressure > 160 mm HG)
    • Dyslipidemia
    • Sleep disorders
    • Any other condition that may affect appetite and energy balance
  • Currently or in the past six months:

    • Use of oral contraceptive pills, or any other hormone-related birth control
    • Progestin-releasing intrauterine device
    • Use of any hormone therapy/medication ( except medication for thyroid conditions, that has not been altered for >6 months)
    • Use of regular medication that may affect appetite, energy balance, or sleep
    • Regular use of tobacco or nicotine products
  • Starting any new prescription medication within two weeks of the first study day visit or during the study

  • If applicable, inability to abstain from supplements or herbal products that may impact sex hormones (e.g., chastetree, phytoestrogens, calcium d glucarate, soy isoflavones, maca, black cohosh, red raspberry, etc.) for two weeks prior to the first study day visit and until the second study day visit and free-living assessments are completed.

  • Working night shifts or traveling across more than 2 time zones within two weeks of and throughout the study

  • Food intolerances or allergies that cannot be accommodated

  • History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons

  • Current alcohol or substance abuse (score >1 on the cut down-annoyed-guilty-eye opener [CAGE] questionnaire)

  • Current or past history of eating disorders including anorexia nervosa, bulimia, binge eating disorder (self-report or score >20 on the Eating Attitudes Test - 26 [EATS-26] questionnaire)

  • Current severe depression or history of severe depression within the previous year, based on score > 30 on Beck Depression Inventory (BDI)

  • Weight loss >5kg in past 12 weeks for any reason

  • Weight loss of >20 kgs in past 3 years for any reason

Key Trial Info

Start Date :

June 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 31 2025

Estimated Enrollment :

23 Patients enrolled

Trial Details

Trial ID

NCT06327087

Start Date

June 1 2022

End Date

May 31 2025

Last Update

April 4 2024

Active Locations (1)

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University of British Columbia - Okanagan

Kelowna, British Columbia, Canada, V1V1V7