Appetitive BehaviorNCT06327087
Appetite and Dietary Intake Across the Menstrual Cycle
An observational study of Appetitive Behavior and Healthy, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Appetitive Behavior, Healthy, Dietary Habits
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
Study population: Healthy sedentary or recreationally active females with normal menstrual cycles
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia - Okanagan
Kelowna, British Columbia, V1V1V7
About this study
Official title: Appetite and Energy Balance Parameters Across the Menstrual Cycle
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.
Read the 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 women. Dietary intake varies across the menstrual cycle, with higher self-reported energy intake in the luteal phase. However, it is unclear how physiological and behavioral parameters such as appetite, resting metabolic rate, body composition, physical activity, or premenstrual symptoms relate to energy intake fluctuations. Furthermore, only two studies have measured free-living objective dietary intake across the menstrual cycle, neither of which have measured other aspects of energy balance in detail. This study will help address these knowledge gaps by characterizing several aspects of energy balance in both laboratory and free-living settings in healthy pre-menstrual women across the menstrual cycle. Twenty-three women (for complete data on n=18) aged 18-35 without major comorbidities and with normal menstrual cycles will be enrolled in an observational trial. In addition to a baseline visit to measure body composition, participants will undergo two 4.5-hour study visits, one of which will occur in the follicular phase and the other in the luteal phase (as confirmed with multiple low-burden methods including self-reported menstrual cycle history and urinary luteinizing hormone). Participants will be given a two-day run-in diet prior to each study day to ensure energy balance. On each study day visit, participants will undergo a resting metabolic rate test followed by a series of fasting saliva samples quantitatively pooled to measure estradiol and progesterone. Following collection of fasted ratings of appetite, participants will be provided with a standard breakfast meal. Appetite ratings will be repeated 30, 60, 90, 120, 150, and 180 minutes after the meal. Questionnaires related to eating behavior will also be completed during this time. After the 180-minute timepoint, participants will be provided with a buffet-like lunch meal with instructions to eat as much or as little as they would like; this will allow measurement of ad libitum dietary intake at a single meal. To assess free-living ad libitum dietary intake, participants will receive three days of food boxes tailored to their preferences, with uneaten food returned at the end of the three-day period. After each study visit, participants will be asked to record their dietary intake and appetite (three days) and wear and activity monitor (seven days). Differences in outcomes between visits will be assessed using paired samples t-tests and relationships among variables will be assessed via Pearson correlations. This study will provide preliminary evidence of the factors associated with dietary intake fluctuations across the menstrual cycle and provide essential preliminary data that could inform future weight management and health-promotion strategies.
- Conditions
- Appetitive Behavior, Healthy, Dietary Habits
- Being tested
- No intervention
- Keywords
- energy expenditure, appetite sensations, diet
- Medical subject headings
- Appetitive Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study in the late follicular and mid-luteal phase
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Ad libitum intake at lunch; difference between energy in weighed food before and after consumption in a laboratory setting
Measured: 1 hour
Hunger area under the curve
Repeated visual analog scale (0-100mm) ratings of hunger after a standard breakfast meal
Measured: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
Satiety area under the curve
Repeated visual analog scale (0-100mm) ratings of satiety after a standard breakfast meal
Measured: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
Prospective food consumption area under the curve
Repeated visual analog scale (0-100mm) ratings of prospective food consumption after a standard breakfast meal
Measured: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
Secondary outcomes (6)
Free-living ad libitum energy intake
Ad libitum intake; difference between energy in weighed food before and after consumption, provided to participants in free-living environments
Measured: 2.5 days following study visit
Resting metabolic rate
Resting metabolic rate, via indirect calorimetry (metabolic cart)
Measured: 30 minutes
Body composition
Fat mass and fat-free mass from dual X-ray absorptiometry
Measured: 30 minutes
Estradiol
Concentration of circulating estradiol, measured from saliva
Measured: 5 minutes
Progesterone
Concentration of circulating progesterone, measured from saliva
Measured: 5 minutes
Physical activity patterns
Physical activity patterns (e.g., steps/day, time spent sitting, or in moderate-to-vigorous physical activity) from activPAL accelerometers
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Jun 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Purcell, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327087
- Sponsor's protocol ID
- 22-00874
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be made available to researchers upon reasonable request.
Publications
Smith M, Aghayan M, Little J, Prior JC, Cohen TR, Soon Z, Bomide H, Purcell S. Energy intake and appetite in laboratory and free-living conditions may be consistent across menstrual cycle phases. Appetite. 2026 Jan 1;216:108314. doi: 10.1016/j.appet.2025.108314. Epub 2025 Sep 25.
PubMed 41005066
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite and Energy Balance Parameters Across the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT06327087
- Acronym / sponsor ID
- 22-00874
- Conditions
- Appetitive Behavior, Healthy, Dietary Habits
- Keywords
- energy expenditure, appetite sensations, diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 women. Dietary intake varies across the menstrual cycle, with higher self-reported energy intake in the luteal phase. However, it is unclear how physiological and behavioral parameters such as appetite, resting metabolic rate, body composition, physical activity, or premenstrual symptoms relate to energy intake fluctuations. Furthermore, only two studies have measured free-living objective dietary intake across the menstrual cycle, neither of which have measured other aspects of energy balance in detail. This study will help address these knowledge gaps by characterizing several aspects of energy balance in both laboratory and free-living settings in healthy pre-menstrual women across the menstrual cycle. Twenty-three women (for complete data on n=18) aged 18-35 without major comorbidities and with normal menstrual cycles will be enrolled in an observational trial. In addition to a baseline visit to measure body composition, participants will undergo two 4.5-hour study visits, one of which will occur in the follicular phase and the other in the luteal phase (as confirmed with multiple low-burden methods including self-reported menstrual cycle history and urinary luteinizing hormone). Participants will be given a two-day run-in diet prior to each study day to ensure energy balance. On each study day visit, participants will undergo a resting metabolic rate test followed by a series of fasting saliva samples quantitatively pooled to measure estradiol and progesterone. Following collection of fasted ratings of appetite, participants will be provided with a standard breakfast meal. Appetite ratings will be repeated 30, 60, 90, 120, 150, and 180 minutes after the meal. Questionnaires related to eating behavior will also be completed during this time. After the 180-minute timepoint, participants will be provided with a buffet-like lunch meal with instructions to eat as much or as little as they would like; this will allow measurement of ad libitum dietary intake at a single meal. To assess free-living ad libitum dietary intake, participants will receive three days of food boxes tailored to their preferences, with uneaten food returned at the end of the three-day period. After each study visit, participants will be asked to record their dietary intake and appetite (three days) and wear and activity monitor (seven days). Differences in outcomes between visits will be assessed using paired samples t-tests and relationships among variables will be assessed via Pearson correlations. This study will provide preliminary evidence of the factors associated with dietary intake fluctuations across the menstrual cycle and provide essential preliminary data that could inform future weight management and health-promotion strategies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Healthy sedentary or recreationally active females with normal menstrual cycles
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (30 listed)
- Current or previous major comorbidities, by self-report, including:
- Uncontrolled/untreated (self-report):
- Currently or in the past six months:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study in the late follicular and mid-luteal phase | Other | – |
Primary outcome
Energy intake
Time frame: 1 hour
Ad libitum intake at lunch; difference between energy in weighed food before and after consumption in a laboratory setting
Hunger area under the curve
Time frame: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
Repeated visual analog scale (0-100mm) ratings of hunger after a standard breakfast meal
Satiety area under the curve
Time frame: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
Repeated visual analog scale (0-100mm) ratings of satiety after a standard breakfast meal
Prospective food consumption area under the curve
Time frame: 3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
Repeated visual analog scale (0-100mm) ratings of prospective food consumption after a standard breakfast meal
6 secondary outcomes
Free-living ad libitum energy intake
Time frame: 2.5 days following study visit
Resting metabolic rate
Time frame: 30 minutes
Body composition
Time frame: 30 minutes
Estradiol
Time frame: 5 minutes
Progesterone
Time frame: 5 minutes
Physical activity patterns
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Results publication: PubMed 41005066Smith M, Aghayan M, Little J, Prior JC, Cohen TR, Soon Z, Bomide H, Purcell S. Energy intake and appetite in laboratory and free-living conditions may be consistent across menstrual cycle phases. Appetite. 2026 Jan 1;216:108314. doi: 10.1016/j.appet.2025.108314. Epub 2025 Sep 25.
- Individual participant dataSharing planned: No. De-identified data will be made available to researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appetitive Behavior and Healthy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.