ClinicalTrials.gg
CompletedNCT03305237Updated Apr 6, 2020

The Meal Time Study

An interventional study of Big Breakfast and Big Dinner in Obesity and Weight Loss, sponsored by University of Aberdeen. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-06.

Sponsored by University of Aberdeen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Obesity by University of Aberdeen — 2 open to participants now, 2 under way, none of them phase 3. Obesity · University of Aberdeen.

Started
2017
with 1 other
No phase
8 of 11
1 open now
Registered
6th of 11
by date

Among the 11 studies in Obesity by University of Aberdeen, this one is one of 2 that started in 2017, is one of 8 with no phase, and was the 6th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

2 of the 11 studies in Obesity by University of Aberdeen are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Obesity by University of Aberdeen, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Obesity
  • Weight Loss

Keywords

  • Weight loss
  • Chrono-nutrition
  • Diet
  • energy expenditure
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 ) 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    big breakfast (BB) to big dinner (BD)

    Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BB energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BD energy restriction diets for 4 weeks

    Other: Big Breakfast · Other: Big Dinner

  • Experimental
    big dinner (BD) to big breakfast (BB)

    Phase 1: no intervention, habitual diet for 4 days and then 4day maintenance diet Phase 2: consumption of BD energy restriction diets for 4 weeks Phase 3: washout for 1 week, controlled maintenance diet Phase 4: consumption of BB energy restriction diets for 4 weeks

    Other: Big Breakfast · Other: Big Dinner

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.

06

What researchers measure

Primary outcomes

  1. Energy balance

    Change in energy balance during each diet protocol (body weight (kg))

    Time frame: Measured up to day 71 of study

Secondary outcomes

  1. Total Daily Energy Expenditure

    Total energy expenditure measured by DLW for the 4 week BB and BD diet phases

    Time frame: 4 x 2 weeks. Throughout weeks 2-5 and 7-10.

  2. Resting Metabolic Rate (RMR)

    RMR measured with indirect calorimetry (ventilated hood)

    Time frame: Baseline,week 1, week 5, week 6, week 10.

  3. Thermic effect of food (TEF)

    TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal

    Time frame: Week 1, week 5, week 6, week 10.

  4. Body Volume

    Measured with Air Displacement plethysmography (BODPOD),

    Time frame: Week 1, week 5, week 6, week 10.

  5. Bone Mineral Content

    Measured with Dual energy x-ray absorptiometry (DEXA)

    Time frame: Week 1, week 5, week 6, week 10.

  6. Total Body Water

    Measured with deuterium dilution

    Time frame: Week 1, week 5, week 6, week 10.

  7. Body Composition

    4 compartment model to assess changes in body composition (Combined from the measures of body weight, body volume, total body water and bone mineral)

    Time frame: Week 1, week 5, week 6, week 10.

  8. Gastric emptying

    Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.

    Time frame: Week 1, week 5, week 6, week 10.

  9. Waist and hip circumference

    Change in waist and hip circumferences and waist to hip ratio

    Time frame: Week 1, week 5, week 6, week 10.

  10. Gut appetite hormones

    Change in plasma fasting and 2 hr post-meal appetite hormones

    Time frame: Week 1, week 5, week 6, week 10.

  11. Plasma glucose

    Change in plasma fasting and 2 hr post-meal glucose

    Time frame: Week 1, week 5, week 6, week 10.

  12. Plasma insulin

    Change in plasma fasting and 2 hr post-meal insulin

    Time frame: Week 1, week 5, week 6, week 10.

  13. Blood lipids

    Change in plasma fasting and 2 hr post-meal blood lipids

    Time frame: Week 1, week 5, week 6, week 10.

  14. Daily Subjective Appetite

    Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.

    Time frame: Hourly measures for 3 days in week 1,week 5, week 6, week 10.

  15. Postprandial Subjective Appetite

    Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every 30 minutes for 6 hours after test meals.

    Time frame: Week 1, week 5, week 6, week 10.

  16. Faecal sample analysis for gut health

    Chronic influence on changes in gut microbiota

    Time frame: Week 1, week 5, week 6, week 10.

  17. Physical activity

    Change in physical activity levels measured with accelerometer (actigraph)

    Time frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.

  18. 24 hour blood glucose

    Changes in 24 hour blood glucose levels measured with a continuous glucose monitor

    Time frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.

07

Study locations

1 site
  • The Rowett Institute
    Aberdeen, AB25 2ZD, United Kingdom
08

References and documents

Publications

  • Ruddick-Collins LC, Morgan PJ, Fyfe CL, Filipe JAN, Horgan GW, Westerterp KR, Johnston JD, Johnstone AM. Timing of daily calorie loading affects appetite and hunger responses without changes in energy metabolism in healthy subjects with obesity. Cell Metab. 2022 Oct 4;34(10):1472-1485.e6. doi: 10.1016/j.cmet.2022.08.001. Epub 2022 Sep 9. PubMed 36087576 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Feb 2020, 28 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 28 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2017
First posted
Oct 9, 2017
StartActual
Oct 24, 2017
Primary completionActual
Feb 28, 2020
CompletionActual
Feb 28, 2020
Last update
Apr 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03305237
Collaborators
University of Surrey, Maastricht University
Responsible party
Sponsor
First posted
Oct 9, 2017
Start date
Oct 24, 2017
Primary completion
Feb 28, 2020
Completion
Feb 28, 2020
Last update
Apr 6, 2020

Study contacts

Alexandra M Johnstone, PhD
principal investigator · University of Aberdeen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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