Appetite and Dietary Intake Across the Menstrual Cycle

April 27, 2026 updated by: Sarah Purcell, University of British Columbia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V1V7
        • University of British Columbia - Okanagan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy sedentary or recreationally active females with normal menstrual cycles

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 hour
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
3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
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
3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)
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
3 hours (pre and 30, 60, 90, 120, 150, and 180 minutes after breakfast)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Free-living ad libitum energy intake
Time Frame: 2.5 days following study visit
Ad libitum intake; difference between energy in weighed food before and after consumption, provided to participants in free-living environments
2.5 days following study visit
Resting metabolic rate
Time Frame: 30 minutes
Resting metabolic rate, via indirect calorimetry (metabolic cart)
30 minutes
Body composition
Time Frame: 30 minutes
Fat mass and fat-free mass from dual X-ray absorptiometry
30 minutes
Estradiol
Time Frame: 5 minutes
Concentration of circulating estradiol, measured from saliva
5 minutes
Progesterone
Time Frame: 5 minutes
Concentration of circulating progesterone, measured from saliva
5 minutes
Physical activity patterns
Time Frame: 7 days
Physical activity patterns (e.g., steps/day, time spent sitting, or in moderate-to-vigorous physical activity) from activPAL accelerometers
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-00874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data will be made available to researchers upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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