ObesityNCT03305237
The Meal Time Study
A study testing Big Breakfast and Big Dinner in people with Obesity and Weight Loss, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Big Breakfast and Big Dinner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2017to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ranging from 27-42 kg/m2;
- Those habitually consuming breakfast (at least 5 times a week).
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight
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.
- Conditions
- Obesity, Weight Loss
- Being tested
- Big Breakfast, Big Dinner
- Keywords
- Weight loss, Chrono-nutrition, Diet, energy expenditure
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Big BreakfastOther
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.
Big DinnerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| big breakfast (BB) to big dinner (BD) | Experimental | 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 Receives: Other: Big Breakfast; Other: Big Dinner |
| big dinner (BD) to big breakfast (BB) | Experimental | 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 Receives: Other: Big Breakfast; Other: Big Dinner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy balance
Change in energy balance during each diet protocol (body weight (kg))
Measured: Measured up to day 71 of study
Secondary outcomes (18)
Total Daily Energy Expenditure
Total energy expenditure measured by DLW for the 4 week BB and BD diet phases
Measured: 4 x 2 weeks. Throughout weeks 2-5 and 7-10.
Resting Metabolic Rate (RMR)
RMR measured with indirect calorimetry (ventilated hood)
Measured: Baseline,week 1, week 5, week 6, week 10.
Thermic effect of food (TEF)
TEF measured with indirect calorimetry (ventilated hood) for 6 hours after a breakfast meal
Measured: Week 1, week 5, week 6, week 10.
Body Volume
Measured with Air Displacement plethysmography (BODPOD),
Measured: Week 1, week 5, week 6, week 10.
Bone Mineral Content
Measured with Dual energy x-ray absorptiometry (DEXA)
Measured: Week 1, week 5, week 6, week 10.
Total Body Water
Measured with deuterium dilution
Measured: Week 1, week 5, week 6, week 10.
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)
Measured: Week 1, week 5, week 6, week 10.
Gastric emptying
Gastric emptying measured using stable isotope, Octanoic acid labelled breath samples.
Measured: Week 1, week 5, week 6, week 10.
Waist and hip circumference
Change in waist and hip circumferences and waist to hip ratio
Measured: Week 1, week 5, week 6, week 10.
Gut appetite hormones
Change in plasma fasting and 2 hr post-meal appetite hormones
Measured: Week 1, week 5, week 6, week 10.
Plasma glucose
Change in plasma fasting and 2 hr post-meal glucose
Measured: Week 1, week 5, week 6, week 10.
Plasma insulin
Change in plasma fasting and 2 hr post-meal insulin
Measured: Week 1, week 5, week 6, week 10.
Blood lipids
Change in plasma fasting and 2 hr post-meal blood lipids
Measured: Week 1, week 5, week 6, week 10.
Daily Subjective Appetite
Changes in subjective appetite (hunger, fullness, desire to eat) measured using visual analogue scale questionnaires every waking hour for 3 days.
Measured: Hourly measures for 3 days in week 1,week 5, week 6, week 10.
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.
Measured: Week 1, week 5, week 6, week 10.
Faecal sample analysis for gut health
Chronic influence on changes in gut microbiota
Measured: Week 1, week 5, week 6, week 10.
Physical activity
Change in physical activity levels measured with accelerometer (actigraph)
Measured: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
24 hour blood glucose
Changes in 24 hour blood glucose levels measured with a continuous glucose monitor
Measured: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start24 Oct 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey, Maastricht University
- Responsible party
- Sponsor
- Investigators
- Alexandra M Johnstone, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305237
- Sponsor's protocol ID
- 806
- Other IDs
- MR/P012205/1
- Status last verified
- Apr 2020
- First submitted
- 26 Sep 2017
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Big Breakfast Study: Chrono-nutrition Influence on Energy Expenditure and Body Weight
- ClinicalTrials.gov ID
- NCT03305237
- Acronym / sponsor ID
- 806
- Conditions
- Obesity, Weight Loss
- Keywords
- Weight loss, Chrono-nutrition, Diet, energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- University of Surrey, Maastricht University
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| big breakfast (BB) to big dinner (BD) | Experimental | Other: Big Breakfast, Other: Big DinnerPhase 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 |
| big dinner (BD) to big breakfast (BB) | Experimental | Other: Big Breakfast, Other: Big DinnerPhase 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ranging from 27-42 kg/m2;
- Those habitually consuming breakfast (at least 5 times a week).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Big BreakfastWeight 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. | Other | big breakfast (BB) to big dinner (BD), big dinner (BD) to big breakfast (BB) |
| Big DinnerWeight 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. | Other | big breakfast (BB) to big dinner (BD), big dinner (BD) to big breakfast (BB) |
Primary outcome
Energy balance
Time frame: Measured up to day 71 of study
Change in energy balance during each diet protocol (body weight (kg))
18 secondary outcomes
Total Daily Energy Expenditure
Time frame: 4 x 2 weeks. Throughout weeks 2-5 and 7-10.
Resting Metabolic Rate (RMR)
Time frame: Baseline,week 1, week 5, week 6, week 10.
Thermic effect of food (TEF)
Time frame: Week 1, week 5, week 6, week 10.
Body Volume
Time frame: Week 1, week 5, week 6, week 10.
Bone Mineral Content
Time frame: Week 1, week 5, week 6, week 10.
Total Body Water
Time frame: Week 1, week 5, week 6, week 10.
Body Composition
Time frame: Week 1, week 5, week 6, week 10.
Gastric emptying
Time frame: Week 1, week 5, week 6, week 10.
Waist and hip circumference
Time frame: Week 1, week 5, week 6, week 10.
Gut appetite hormones
Time frame: Week 1, week 5, week 6, week 10.
Plasma glucose
Time frame: Week 1, week 5, week 6, week 10.
Plasma insulin
Time frame: Week 1, week 5, week 6, week 10.
Blood lipids
Time frame: Week 1, week 5, week 6, week 10.
Daily Subjective Appetite
Time frame: Hourly measures for 3 days in week 1,week 5, week 6, week 10.
Postprandial Subjective Appetite
Time frame: Week 1, week 5, week 6, week 10.
Faecal sample analysis for gut health
Time frame: Week 1, week 5, week 6, week 10.
Physical activity
Time frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
24 hour blood glucose
Time frame: Measured continuously for 24 hours for 3 days in week 1,week 5, week 6, week 10.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Derived from this study: PubMed 36087576Ruddick-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra M Johnstone, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Big Breakfast and Big Dinner in people with Obesity and Weight Loss, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy balance (time frame: Measured up to day 71 of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03305237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.