The Effect of Irregular Meal Pattern on Nitrogen Balance in Healthy Normal-weight Women
NCT ID: NCT05226650
Last Updated: 2022-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
14 participants
INTERVENTIONAL
2019-09-13
2021-12-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Irregular Meal Pattern Providing Hypo-energetic Diet on Energy Expenditure and Metabolism
NCT05569837
Influence of the Constancy of Daily Meal Pattern on Energy Balance, Glucose Profiles an Appetite in Healthy Women
NCT02052076
Impaired Regulation of Energy Balance in Elderly People (Balance Study)
NCT00561145
Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)
NCT03328546
Fat Burning After a Meal
NCT02211599
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Firstly, a screening visit lasting approximately an hour will be arranged and height, weight, and waist circumference will be measured following standard procedures (eg without shoes, wearing light clothes). Body composition will be obtained using skinfold thickness at four sites (triceps, biceps, subscapular and suprailiac). A blood sample (8 ml) will be obtained for routine blood investigation. A number of questionnaires will be completed to assess medical health, sleep duration, physical activity levels, eating behaviour and depression. On departure, subjects will be asked to complete a 4 days food diary.
The present study will last for 5 weeks. During the first week participants will be required to adopt one of two meal patterns, followed by a three week washout period, in which they will be allowed to return to their habitual diet, before undertaking a second week intervention following the second meal pattern. These meal patterns will consist of consuming 1) a regular meal pattern of 6 daily meals for two weeks, or 2) an irregular one consisting of consuming a different number of meals every day (between 3 and 9). Investigators propose to provide an iso-energetic diet containing identical foods with macronutrient composition (as a percentage of total energy per day) of 50% carbohydrate, 35% fat, and 15% protein for both patterns. All foods to be consumed during the study (1st and 5th week) will be provided free of charge. These will comprise foods commonly consumed in the British diet and will be consumed in amounts designed to keep body weight constant during the study. Participants will complete a food compliance diary over the study period. Physical activity will be captured by BodyMedia SenseWear armband to ensure that participants have a similar physical activity level in both intervention periods. This device records and analyses physiological parameters, and uses algorithms to report daily movement, calories burned, degree of physical activity and steps taken. It will be placed on the back of the upper left arm (the tricep). The Armband logo must face upward towards the shoulder and the silver sensors on the underside of the Armband will be in contact with skin.
Participants will be advised to consume a standardized evening meal based on their food record on the day before the start of each intervention and to provide 7, 24-h urine samples over the course of each intervention period. All urine was collected from study participants for 24 hr beginning at 7 am. Urine will be collected into 7 plastic urine containers without preservative. 5 ml will be stored from the well-mixed 24-h urine collection and analysed for urinary urea. In addition, they will be advised to wear a wireless iButton data logger to measure the wrist temperature in order to assess the circadian rhythm. The iButtons will be programmed to sample every 10 min, and will be attached to a double-sided cotton sport wrist band usingVelcro®, with the sensor face of the iButton being placed over the inside of the wrist, on the radial artery of the non-dominant hand.
Finally, subjective appetite (including hunger, fullness and desire to eat) will be assessed using visual analogue scales (VAS) during the intervention. Participants will be provided with a booklet in which to record the subjective appetite before and after each single meal on day 7 during both intervention periods when the subjects consume 6 meals/d during each intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Regular meal pattern
Participants will follow a regular meal pattern for a week
Regular meal pattern
6 meals every day
Irregular meal pattern
Participants will follow an irregular meal pattern for a week
Irregular meal pattern
It consists of consuming a different number of meals every day (between 3 and 9).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Regular meal pattern
6 meals every day
Irregular meal pattern
It consists of consuming a different number of meals every day (between 3 and 9).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
19 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nottingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Moira Taylor
Dr Moira A Taylor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ian Macdonald, PhD
Role: STUDY_DIRECTOR
University of Nottingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Nottingham
Nottingham, County (optional), United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Alhussain MH, Macdonald IA, Taylor MA. Irregular meal-pattern effects on energy expenditure, metabolism, and appetite regulation: a randomized controlled trial in healthy normal-weight women. Am J Clin Nutr. 2016 Jul;104(1):21-32. doi: 10.3945/ajcn.115.125401. Epub 2016 Jun 15.
Dickerson, R. N. (2005). Using nitrogen balance in clinical practice. Hospital Pharmacy, 40(12), 1081-1087
Farshchi HR, Taylor MA, Macdonald IA. Regular meal frequency creates more appropriate insulin sensitivity and lipid profiles compared with irregular meal frequency in healthy lean women. Eur J Clin Nutr. 2004 Jul;58(7):1071-7. doi: 10.1038/sj.ejcn.1601935.
Farshchi HR, Taylor MA, Macdonald IA. Decreased thermic effect of food after an irregular compared with a regular meal pattern in healthy lean women. Int J Obes Relat Metab Disord. 2004 May;28(5):653-60. doi: 10.1038/sj.ijo.0802616.
Farshchi HR, Taylor MA, Macdonald IA. Beneficial metabolic effects of regular meal frequency on dietary thermogenesis, insulin sensitivity, and fasting lipid profiles in healthy obese women. Am J Clin Nutr. 2005 Jan;81(1):16-24. doi: 10.1093/ajcn/81.1.16.
Garrow JS, Durrant M, Blaza S, Wilkins D, Royston P, Sunkin S. The effect of meal frequency and protein concentration on the composition of the weight lost by obese subjects. Br J Nutr. 1981 Jan;45(1):5-15. doi: 10.1079/bjn19810072.
McGinnis GR, Young ME. Circadian regulation of metabolic homeostasis: causes and consequences. Nat Sci Sleep. 2016 May 27;8:163-80. doi: 10.2147/NSS.S78946. eCollection 2016.
Pot GK, Hardy R, Stephen AM. Irregular consumption of energy intake in meals is associated with a higher cardiometabolic risk in adults of a British birth cohort. Int J Obes (Lond). 2014 Dec;38(12):1518-24. doi: 10.1038/ijo.2014.51. Epub 2014 Mar 28.
Pot GK, Hardy R, Stephen AM. Irregularity of energy intake at meals: prospective associations with the metabolic syndrome in adults of the 1946 British birth cohort. Br J Nutr. 2016 Jan 28;115(2):315-23. doi: 10.1017/S0007114515004407. Epub 2015 Nov 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
189-1812
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.