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The Effect of Irregular Meal Pattern on Nitrogen Balance in Healthy Normal-weight Women

The Effect of Irregular Meal Pattern on Nitrogen Balance: a Randomized Controlled Trial in Healthy Normal-weight Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05226650
Enrollment
14
Registered
2022-02-07
Start date
2019-09-13
Completion date
2021-12-23
Last updated
2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nitrogen Balance

Brief 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.

Detailed description

The study will have a crossover randomised, non blinded two meal pattern design with healthy adult female volunteers recruited from Nottingham, UK and the surrounding area. 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.

Interventions

6 meals every day

It consists of consuming a different number of meals every day (between 3 and 9).

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Nitrogen balance7 daysNitrogen balance will be calculated using urinary urea nitrogen which will be estimated from 24 hour urinary urea excretion

Secondary

MeasureTime frameDescription
Subjective appetiteBefore and after each single meal on day 7 during both intervention periodsIt (including hunger, fullness and desire to eat) will be assessed during the intervention using a 100 mm scale. 100 mm represents the highest experience possible of the sensation and 0 represents no experience of the sensation. Participants were 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
Wrist temperature7 daysWrist temperature will be assessed using a wireless wrist iButton

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026