NCT06327087

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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

February 27, 2024

Last Update Submit

April 27, 2026

Conditions

Keywords

energy expenditureappetite sensationsdiet

Outcome Measures

Primary Outcomes (4)

  • Energy intake

    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

    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

    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

    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 Outcomes (6)

  • Free-living ad libitum energy intake

    2.5 days following study visit

  • Resting metabolic rate

    30 minutes

  • Body composition

    30 minutes

  • Estradiol

    5 minutes

  • Progesterone

    5 minutes

  • +1 more secondary outcomes

Interventions

Observational study in the late follicular and mid-luteal phase

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy sedentary or recreationally active females with normal menstrual cycles

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia - Okanagan

Kelowna, British Columbia, V1V1V7, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Appetitive BehaviorFeeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 25, 2024

Study Start

June 1, 2022

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations