Last updated: April 2, 2024
Sponsor: University of British Columbia
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
No intervention
Clinical Study ID
NCT06327087
22-00874
Ages 18-35 Female
Study Summary
Eligibility Criteria
Inclusion
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 voluntaryexercise at moderate intensity or greater over the past 12 weeks
- Not currently pregnant or lactating, not planning to become pregnant in the next 12weeks
- 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 (includingcannabidiol-based products): ability and willingness to abstain from cannabis fortwo days prior to each study day visit, the day of each study visit, and duringeach ad libitum diet phase.
- For people who use cannabis daily: ability and willingness to continue to use theexact same amount of cannabis as they normally use for two days prior to eachstudy day visit, the day of each study visit, and during each ad libitum dietphase.
Exclusion
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 bloodpressure > 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 visitor during the study
- If applicable, inability to abstain from supplements or herbal products that mayimpact sex hormones (e.g., chastetree, phytoestrogens, calcium d glucarate, soyisoflavones, maca, black cohosh, red raspberry, etc.) for two weeks prior to the firststudy day visit and until the second study day visit and free-living assessments arecompleted.
- Working night shifts or traveling across more than 2 time zones within two weeks ofand throughout the study
- Food intolerances or allergies that cannot be accommodated
- History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastricbypass, 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, bingeeating 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 Design
Total Participants: 23
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
May 31, 2025
Study Description
Connect with a study center
University of British Columbia - Okanagan
Kelowna, British Columbia V1V1V7
CanadaActive - Recruiting

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