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The Meal Time Study

The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03305237
Enrollment
31
Registered
2017-10-09
Start date
2017-10-24
Completion date
2020-02-28
Last updated
2020-04-06

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

Conditions

Obesity, Weight Loss

Keywords

Weight loss, Chrono-nutrition, Diet, energy expenditure

Brief summary

This weight loss study will investigate the impact of calorie distribution across a day (large breakfast meals and smaller evening meals versus small breakfast meals and large evening meals) on body weight, and physiological and behavioral mechanisms regulating energy balance. Participants will undergo 2 x 4 week energy restriction protocols in a randomized cross over design; big breakfast (45% of calories in the morning meal, 20% at dinner) and big dinner (45% of calories in the evening meal, 20% at breakfast). We predict that timing of eating will influence energy balance, because morning energy expenditure is amplified in comparison to the evening. This study will allow us to assess whether the increased energy expenditure in the morning is linked to natural biological circadian rhythm or behavioral adaptions.

Detailed description

Dietary advice for weight management is broadly based on the assumption that a 'calorie is a calorie' and it does not matter when calories are consumed across the day. Recent evidence has challenged this assumption, suggesting that we may utilize calories more efficiently when consumed in the morning relative to the evening, and this could be used as a beneficial strategy for weight loss - this is a newly developing field of investigation which merges circadian biology with nutrition (chrono-nutrition). Timing of food consumption is a modifiable factor influencing energy balance and body weight (and thus, disease risk). Previous research has shown that calories ingested at different times of the day have different effects on energy utilization, leading to differential weight loss, even at iso-caloric amounts. This study will aim to increase our understanding of the underlying behavioral and physiological mechanisms associated with differential weight loss and energy balance when calories are consumed predominantly in the morning versus in the evening. This study will be a cross-over study comparing large breakfast versus large evening meals (percent daily calories split between breakfast, lunch and dinner as 45-35-20 (breakfast-loaded) or 20-35-45 (evening-loaded)) during energy restriction (Fed to measured RMR) on energy balance, through differences in both physiological and behavioural changes in energy expenditure and substrate utilization.

Interventions

OTHERBig Breakfast

Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at breakfast (percent daily calories split between breakfast, lunch and dinner as 45-35-20%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.

OTHERBig Dinner

Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at dinner (percent daily calories split between breakfast, lunch and dinner as 20-35-45%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.

Sponsors

University of Surrey
CollaboratorOTHER
Maastricht University
CollaboratorOTHER
University of Aberdeen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI ranging from 27-42 kg/m2; * Those habitually consuming breakfast (at least 5 times a week).

Exclusion criteria

* women who are pregnant, planning to be pregnant or breastfeeding * subjects with food allergies which prevent consumption of the study diet. * diagnosis of diabetes, hypertension, renal, hepatic, haematological disease, coronary heart disease, metabolic disease, gastrointestinal disease * having given a pint of blood for transfusion purposes within the last month * unsuitable veins for blood sampling * inability to understand the participant information sheet * inability to speak, read and understand the English language * those on any prescription medications (other than oral contraceptives) which will adversely affect the study outcomes (i.e. medications affecting, circadian timing, sleep or metabolic function). * those on any specific diet regimes * those on any weight loss programmes (that may be affecting lifestyle, physical activity and diet). * Extremes of chronotypes, sleep patterns and physical activity.

Design outcomes

Primary

MeasureTime frameDescription
Energy balanceMeasured up to day 71 of studyChange in energy balance during each diet protocol (body weight (kg))

Secondary

MeasureTime frameDescription
Resting Metabolic Rate (RMR)Baseline,week 1, week 5, week 6, week 10.RMR measured with indirect calorimetry (ventilated hood)
Thermic effect of food (TEF)Week 1, week 5, week 6, week 10.TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal
Body VolumeWeek 1, week 5, week 6, week 10.Measured with Air Displacement plethysmography (BODPOD),
Bone Mineral ContentWeek 1, week 5, week 6, week 10.Measured with Dual energy x-ray absorptiometry (DEXA)
Total Body WaterWeek 1, week 5, week 6, week 10.Measured with deuterium dilution
Body CompositionWeek 1, week 5, week 6, week 10.4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral)
Gastric emptyingWeek 1, week 5, week 6, week 10.Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.
Waist and hip circumferenceWeek 1, week 5, week 6, week 10.Change in waist and hip circumferences and waist to hip ratio
Total Daily Energy Expenditure4 x 2 weeks. Throughout weeks 2-5 and 7-10.Total energy expenditure measured by DLW for the 4 week BB and BD diet phases
Plasma glucoseWeek 1, week 5, week 6, week 10.Change in plasma fasting and 2 hr post-meal glucose
Plasma insulinWeek 1, week 5, week 6, week 10.Change in plasma fasting and 2 hr post-meal insulin
Blood lipidsWeek 1, week 5, week 6, week 10.Change in plasma fasting and 2 hr post-meal blood lipids
Daily Subjective AppetiteHourly measures for 3 days in week 1,week 5, week 6, week 10.Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.
Postprandial Subjective AppetiteWeek 1, week 5, week 6, week 10.Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals.
Faecal sample analysis for gut healthWeek 1, week 5, week 6, week 10.Chronic influence on changes in gut microbiota
Physical activityMeasured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.Change in physical activity levels measured with accelerometer (actigraph)
24 hour blood glucoseMeasured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.Changes in 24 hour blood glucose levels measured with a continuous glucose monitor
Gut appetite hormonesWeek 1, week 5, week 6, week 10.Change in plasma fasting and 2 hr post-meal appetite hormones

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026