The Effect of Irregular Meal Pattern Providing Hypo-energetic Diet on Energy Expenditure and Metabolism

NCT05569837 | Completed

• 1 other identifier: 473- 2001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we will compare the effect of two different meal patterns. Firstly, participants will consume a diet providing their estimated energy requirement for a 7 day standardisation period (6 meals per day). After a one day laboratory visit, this will be followed by a 14 day intervention period when participants will randomly follow a regular meal pattern (6 meals/d) or an irregular meal pattern (3-9 meals/d). Following a further laboratory visit day, they will then consume the previous standardisation diet for a further 3 days. The energy intake provided will be calculated to provide less energy than subjects are using which may result in approximately 2kg of weight loss. Participants will attend a screening visit in which they will complete questionnaires on medical health, eating habits and physical activity. In the laboratory visit, participants will be fasting and for 3 h after intake of a test drink, measurements will be taken of energy expenditure, fasting glucose, fasting gut hormones, fasting lipids and fasting insulin. A test meal will be offered. A questionnaire of subjective appetite ratings will be assessed while fasting, after the test drink, after the test meal, and during the intervention. Continuous interstitial glucose monitoring will be undertaken during the whole study period, Core body temperature will be measured before and after the intervention period. Also, wrist temperature will be measured during the whole study period.

Conditions

Metabolic Disturbance; Obesity

Outcome Measures

Primary Outcomes (1)

• Change from baseline thermic effect of food in kcal at 2 weeks intervention

  Indirect calorimetry (GEM system; Europa Scientific Ltd.) will be used to determine the resting energy expenditure (REE) and thermic effect of food (TEF). REE will be measured in the fasted state for 20 min. The TEF will be measured for periods of 15 min at 30-min intervals during the 3 h after test drink (milkshake) consumption.

  Over 3 hours for 2 days

Secondary Outcomes (11)

• Change from baseline body Weight in kilograms at 2 weeks intervention

  1 day before intervention and 1 day after intervention

• Change in subjective appetite

  2 days in lab visit, 1 day pre-intervention standardization period, 1 day post-intervention standardization period and 2 days in intervention period

• Continuous interstitial glucose

  26 days

• Change from baseline fasting glucose in mmol/L at 2 weeks intervention

  1 day before intervention and 1 day after intervention

• Change from baseline fasting insulin in mlU/L at 2 weeks intervention

  1 day before intervention and 1 day after intervention

Study Arms (2)

Regular meal pattern

EXPERIMENTAL

Participants will follow a regular meal pattern for 14 days

Other: Regular meal pattern

Irregular meal pattern

EXPERIMENTAL

Participants will follow an irregular meal pattern for 14 days

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: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 18.5 and 30 kg/m2,
• Age between 18 and 45y,
• 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, Nottinghamshire, NG7 2RD, United Kingdom

Location

Related Publications (4)

• 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

• 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

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moira Taylor, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 6, 2022
• Study Start: December 15, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

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)