The Effect of Irregular Meal Pattern on Nitrogen Balance in Healthy Normal-weight Women (NCT05226650) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Irregular Meal Pattern on Nitrogen Balance in Healthy Normal-weight Women
United Kingdom14 participantsStarted 2019-09-13
Plain-language summary
Nitrogen balance (NB) is defined as the net difference between the intake of nitrogen (input) and its excretion (output). NB was considered as an indicator of the catabolic stress level. Thus, a negative NB can occur as a result of catabolism which leads to muscle mass loss. It was demonstrated that there is a relationship between meal frequency and N loss. Irregular meal patterns have been considered as a possible new risk factor for obesity and its consequences, specifically cardiovascular disease and metabolic syndromes. As the regular meal pattern is associated with higher BMI in many observational studies and has an impact on the metabolism of carbohydrates and lipids, it could also affect protein metabolism.
Eating irregularly can cause chrono-disruption because the changes in the timing of food intake as a consequence may also alter the chrono-biological or circadian rhythm of many hormones such as insulin, glucagon, adiponectin, leptin and gastric acid secretion. From this, investigators hypothesized that following an irregular meal pattern can negatively influence the N balance and circadian rhythm.
Who can participate
Age range
19 Years – 40 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:
* BMI between 18.5 and 25 kg/m2,
* Age between 18 and 40y,
* Non-smokers,
* Non high-alcohol consumers (≥ 14 units/week),
* Regular menstruation or on the oral contraceptive pills,
* Their weight is stable during the previous 3 months,
* No self-reported history of serious medical conditions and not under medication.
Exclusion Criteria:
* Pregnant or lactating women
* Smokers
* High-alcohol consumers (≥ 14 units/week)
* Subjects with high score for depression using Becks Depression Inventory
* subjects Eating Attitudes Test (EAT-26) score \>20
* Subjects who on diet or seeking to lose weight
* Subjects with high consumption of coffee or tea \> 3 cups/day
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.