Appetite and Dietary Intake Across the Menstrual Cycle (NCT06327087) | Clinical Trial Compass
CompletedNot Applicable
Appetite and Dietary Intake Across the Menstrual Cycle
Canada31 participantsStarted 2022-06-01
Plain-language 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, relationships between food intake and appetite, metabolism, body composition (i.e., the proportion of muscle and fat), physical activity and premenstrual symptoms have not been reported. This study will measure appetite and food intake in laboratory and usual life settings in healthy pre-menopausal women in two hormonally different parts of the menstrual cycle. Data on ovarian hormones, metabolism, body composition, physical activity and premenstrual symptoms will also be collected to assess their potential relationship with food intake.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Energy intake
Timeframe: 1 hour
2
Hunger area under the curve
Timeframe: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
3
Satiety area under the curve
Timeframe: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
4
Prospective food consumption area under the curve
Timeframe: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)