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

NCT05226650 | Completed

• 1 other identifier: 189-1812
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Nitrogen Balance

Outcome Measures

Primary Outcomes (1)

• Nitrogen balance

  Nitrogen balance will be calculated using urinary urea nitrogen which will be estimated from 24 hour urinary urea excretion

  7 days

Secondary Outcomes (2)

• Subjective appetite

  Before and after each single meal on day 7 during both intervention periods

• Wrist temperature

  7 days

Study Arms (2)

Regular meal pattern

EXPERIMENTAL

Participants will follow a regular meal pattern for a week

Other: Regular meal pattern

Irregular meal pattern

EXPERIMENTAL

Participants will follow an irregular meal pattern for a week

Other: Irregular meal pattern

Interventions

Regular meal pattern OTHER

6 meals every day

Regular meal pattern

Irregular meal pattern OTHER

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

Irregular meal pattern

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

The University of Nottingham

Nottingham, County (optional), NG1 3NT, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 27305952 BACKGROUND

• Dickerson, R. N. (2005). Using nitrogen balance in clinical practice. Hospital Pharmacy, 40(12), 1081-1087

  BACKGROUND

• 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.

  PMID: 15220950 BACKGROUND

• 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.

  PMID: 15085170 BACKGROUND

• 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.

  PMID: 15640455 BACKGROUND

• 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.

  PMID: 7470437 BACKGROUND

• 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.

  PMID: 27313482 BACKGROUND

• 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.

  PMID: 24675713 BACKGROUND

• 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.

  PMID: 26548599 BACKGROUND

Study Officials

• Ian Macdonald, PhD

  University of Nottingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Moira A Taylor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 7, 2022
• Study Start: September 13, 2019
• Primary Completion: December 14, 2021
• Study Completion: December 23, 2021
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: when requested
• Access Criteria: On receipt of requests, data will be made accessible if agreed by the University of Nottingham

Locations

GB (1)