Nitrogen BalanceNCT05226650
The Effect of Irregular Meal Pattern on Nitrogen Balance in Healthy Normal-weight Women
A study testing Regular meal pattern and Irregular meal pattern in people with Nitrogen Balance, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nitrogen Balance
- What is being tested?
- Regular meal pattern and Irregular meal pattern
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Sep 2019to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Nottingham
Nottingham, County (optional), NG1 3NT
About this study
Official title: The Effect of Irregular Meal Pattern on Nitrogen Balance: a Randomized Controlled Trial in Healthy Normal-weight Women
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.
Read the 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.
- Conditions
- Nitrogen Balance
- Being tested
- Regular meal pattern, Irregular meal pattern
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular meal patternOther
6 meals every day
Irregular meal patternOther
It consists of consuming a different number of meals every day (between 3 and 9).
| Study group | Role | What they receive |
|---|---|---|
| Regular meal pattern | Experimental | Participants will follow a regular meal pattern for a week Receives: Other: Regular meal pattern |
| Irregular meal pattern | Experimental | Participants will follow an irregular meal pattern for a week Receives: Other: Irregular meal pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitrogen balance
Nitrogen balance will be calculated using urinary urea nitrogen which will be estimated from 24 hour urinary urea excretion
Measured: 7 days
Secondary outcomes (2)
Subjective appetite
It (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
Measured: Before and after each single meal on day 7 during both intervention periods
Wrist temperature
Wrist temperature will be assessed using a wireless wrist iButton
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start13 Sep 2019
- Primary completion14 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Nitrogen BalanceStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moira Taylor, University of Nottingham
- Investigators
- Ian Macdonald, PhD, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226650
- Sponsor's protocol ID
- 189-1812
- Status last verified
- Sep 2022
- First submitted
- 19 Feb 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis
Publications
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.
PubMed 27305952Dickerson, 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.
PubMed 15220950Farshchi 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.
PubMed 15085170Farshchi 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.
PubMed 15640455Garrow 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.
PubMed 7470437McGinnis 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.
PubMed 27313482Pot 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.
PubMed 24675713Pot 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.
PubMed 26548599
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Irregular Meal Pattern on Nitrogen Balance: a Randomized Controlled Trial in Healthy Normal-weight Women
- ClinicalTrials.gov ID
- NCT05226650
- Acronym / sponsor ID
- 189-1812
- Conditions
- Nitrogen Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular meal pattern | Experimental | Other: Regular meal patternParticipants will follow a regular meal pattern for a week |
| Irregular meal pattern | Experimental | Other: Irregular meal patternParticipants will follow an irregular meal pattern for a week |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular meal pattern6 meals every day | Other | Regular meal pattern |
| Irregular meal patternIt consists of consuming a different number of meals every day (between 3 and 9). | Other | Irregular meal pattern |
Primary outcome
Nitrogen balance
Time frame: 7 days
Nitrogen balance will be calculated using urinary urea nitrogen which will be estimated from 24 hour urinary urea excretion
2 secondary outcomes
Subjective appetite
Time frame: Before and after each single meal on day 7 during both intervention periods
Wrist temperature
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Background: PubMed 27305952Alhussain 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.
- BackgroundDickerson, R. N. (2005). Using nitrogen balance in clinical practice. Hospital Pharmacy, 40(12), 1081-1087
- Background: PubMed 15220950Farshchi 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.
- Background: PubMed 15085170Farshchi 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.
- Background: PubMed 15640455Farshchi 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.
- Background: PubMed 7470437Garrow 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.
- Background: PubMed 27313482McGinnis 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.
- Background: PubMed 24675713Pot 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.
- Background: PubMed 26548599Pot 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.
- Individual participant dataSharing planned: Yes. Only anonymised individual personal data will be shared, upon specific request from other researchers, for example, in order to undertake a meta analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Macdonald, PhD study director
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular meal pattern and Irregular meal pattern in people with Nitrogen Balance, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nitrogen balance (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226650, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.