Clinical trial NCT05569837: The Effect of Irregular Meal Pattern Providing Hypo-energetic Diet on Energy Expenditure and Metabolism
Official title: The Effect of Irregular Meal Pattern Providing Hypo-energetic Diet on Energy Expenditure, Metabolism and Circadian Rhythm: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disturbance
Obesity
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Experimental protocol:

28 women who are a healthy weight or overweight (aged 18-45 years) will be recruited to a randomized parallel trial to follow one of two 14-d hypo-energetic diets. Firstly, participants will consume a diet providing their estimated energy requirement (6 meals/day) for a 7 day standardisation period. After a one day laboratory visit, this will be followed by a 14 day intervention period when participants will follow a regular meal pattern (6 meals/d) or an irregular meal pattern (3-9 meals/d) (energy deficit of 800kcal/ 24h in both diets) (identical foods provided on both interventions whilst otherwise free living). Following a further laboratory visit day, they will then consume the previous standardisation diet providing their estimated energy requirement (6 meals/day) for a further 3 days. All foods to be consumed during the study will be provided to free of charge. These will comprise foods commonly consumed in the British diet and will be consumed in amounts designed to provide 800kcal/24h less than estimated energy requirements in the intervention period. Participants will attend the laboratory visits fasting and a blood sample will be obtained for fasting glucose, insulin and lipids. A test drink will then be given and over the following three hours measurements will be taken of energy expenditure (TEF). An ad libitum pasta test meal will be offered three hours after the test drink has been given. Subjective appetite ratings will be assessed while fasting, after the test drink, after the ad libitum meal, and during the intervention. Continuous interstitial glucose monitoring will be undertaken throughout the study. Ambulatory activity pattern measurement will be assessed in the intervention period. Core body temperature will be measured during the last 3 days of the first standardisation period, and during the final three standardisation days. Peripheral body temperature will be measured throughout the study period using a small i- button secured to the wrist. The study will commence at the early phase of the menstrual cycle (days1-7). A constant sleep-wake (and light exposure) routine will be followed for the whole study period which will be assessed by a written questionnaire form

Eligibility criteria: Inclusion Criteria:

* 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.

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

Primary outcomes:
measure: Change from baseline thermic effect of food in kcal at 2 weeks intervention
timeFrame: Over 3 hours for 2 days
Secondary outcomes:
measure: Change from baseline body Weight in kilograms at 2 weeks intervention
timeFrame: 1 day before intervention and 1 day after intervention
measure: Change in subjective appetite
timeFrame: 2 days in lab visit, 1 day pre-intervention standardization period, 1 day post-intervention standardization period and 2 days in intervention period
measure: Continuous interstitial glucose
timeFrame: 26 days
measure: Change from baseline fasting glucose in mmol/L at 2 weeks intervention
timeFrame: 1 day before intervention and 1 day after intervention
measure: Change from baseline fasting insulin in mlU/L at 2 weeks intervention
timeFrame: 1 day before intervention and 1 day after intervention
measure: Change from baseline fasting lipids in mmol/L at 2 weeks intervention
timeFrame: 1 day before intervention and 1 day after intervention
measure: Change from baseline fasting glucagon-like peptide1 in pM at 2 weeks intervention
timeFrame: 1 day before intervention and 1 day after intervention
measure: Change from baseline fasting peptide YY in pg/ml at 2 weeks intervention
timeFrame: 1 day before intervention and 1 day after intervention
measure: Change from baseline fasting ghrelin in pg/ml at 2 weeks intervention
timeFrame: 1 day before intervention and 1 day after intervention
measure: Change from baseline core body temperature in Celsius at 2 weeks intervention
timeFrame: 3 days in pre and post intervention
measure: Peripheral wrist temperature in Celsius
timeFrame: 26 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: The University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Moira Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.