Physical ActivityNCT04417205
Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention
A study testing Carbohydrate Rich Breakfast and Whey protein enriched breakfast in people with Physical Activity and Postprandial Metabolism, run by University of Bath at 1 site in United Kingdom.
Trial summary
Following the establishment of causal links between breakfast consumption, the individual components of energy balance, and health it is now important to examine and target the underlying biological mechanisms involved to maximise potential health benefits. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Postprandial Metabolism, Weight Loss
- What is being tested?
- Carbohydrate Rich Breakfast and Whey protein enriched breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2019to 1 Aug 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Able and willing to provide informed consent and safely comply with study procedures
- Females to maintain record of regular menstrual cycle phase or contraceptive use
- No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)
- Inclusive to all breakfast habits (e.g. regular skipper / consumer)
Who cannot join
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment (e.g. smoking/substance abuse)
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (± 3%)
Trial locations and contacts
1 site in 1 country.
About this study
Following the establishment of causal links between breakfast consumption, the individual components of energy balance, and health it is now important to examine and target the underlying biological mechanisms involved to maximise potential health benefits.
To begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to take part in phase I (acute design) of a wider project.
Read the detailed description
Causal links between breakfast consumption, the individual components of energy balance, and health have recently been established and it is now important to examine and target the underlying biological mechanisms over a longer period of time to maximise potential health benefits.
Specifically, the substitution of a portion of carbohydrate for protein at breakfast may enhance the potential health benefits of breakfast through targeting distinct mechanistic pathways. Broadly, introducing a greater protein load at breakfast increases insulin secretion and delays gastric emptying, thereby eliciting a potentiated insulin response. In turn this may therefore improve glucose tolerance during a subsequent meal. Additionally, maintenance of euglycaemia following breakfast consumption, coupled with the thermic effect of feeding protein may accentuate the elevated energy expenditure following breakfast observed in previous studies. Finally, both the physical and chemical properties of protein exert a marked satiating effect. Collectively, these mechanisms could interact to maximise the net impact of breakfast on energy balance and associated health outcomes. However, whilst the evidence indicates obvious benefits of feeding a higher protein dose at breakfast, relatively little research has focused on the response to protein over multiple meals/days. Furthermore, and importantly, the mechanisms involved in the second-meal phenomenon and the potential for initial meals of varied composition to target these mechanisms have never been systematically investigated.
To begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to undergo a 4 week intervention study in which they will consume one of three breakfasts for 28-days. The breakfast interventions provide will be:
Carbohydrate rich breakfast
Whey protein enriched breakfast
Extended morning fast
Participants will undergo 7 days of habitual physical activity and diet monitoring prior to visiting the laboratory for their preliminary metabolic assessment in which they will consume the carbohydrate rich breakfast followed by an ad libitum meal for lunch. They will then be randomised to one of the 3 breakfast interventions for 28-days. During the 28-days weekly monitoring of physical activity and energy intake will take place in order to assess energy balance.
Upon completion of the intervention phase participants will revisit the laboratory to replicate the initial visit in which postprandial metabolism was assessed.
- Conditions
- Physical Activity, Postprandial Metabolism, Weight Loss
- Being tested
- Carbohydrate Rich Breakfast, Whey protein enriched breakfast
- Medical subject headings
- Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Rich BreakfastOther
Participants will be asked to consume the provided carbohydrate rich breakfast before 1000h daily for 28 days.
Whey protein enriched breakfastDietary supplement
Participants will be asked to consume the provided whey protein enriched breakfast before 1000h daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate rich breakfast | Active comparator | Participants will be provided with 28-days worth of pre-weighed carbohydrate rich breakfast materials to consume before 1000h daily. Receives: Other: Carbohydrate Rich Breakfast |
| Whey protein enriched breakfast | Experimental | Participants will be provided with 28-days worth of pre-weighed whey protein enriched rich breakfast materials to consume before 1000h daily. Receives: Dietary Supplement: Whey protein enriched breakfast |
| Extended morning fast | No intervention | Participants will be asked to remain fasted (i.e. to not consume breakfast) until 1200h daily for 28-days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity thermogenesis
Energy expenditure measured using physical activity monitor
Measured: Assessed for 1 week at baseline, 3 days a week during weeks 1-3 of the intervention and again for 1 week in the 4th week of the intervention.
Change in expression of circadian clock genes measured in whole blood
Pre and post intervention change clock gene expression
Measured: Baseline and 4-weeks
Change in postprandial glycaemia following carbohydrate rich test breakfast and lunch over 4 weeks
The postprandial time course response of plasma glucose to the test breakfast and lunch meals
Measured: Baseline and 4-weeks
Change in postprandial insulinaemia following carbohydrate rich test breakfast and lunch over 4 weeks
The postprandial time course response of plasma insulin to the test breakfast and lunch meals
Measured: Assessed at baseline and after 4 weeks of the intervention
Change in body mass
Participants will be weighed prior to the intervention and again upon completion
Measured: 4 weeks
Secondary outcomes (3)
Change in postprandial incretin hormone response following breakfast and lunch
The postprandial time course response of plasma incretin hormones (e.g. GLP-1 \& GIP) to the the test breakfast.
Measured: Baseline and 4 weeks
Change in subjective appetite ratings following breakfast and lunch
Ratings of appetite provided on subjective appetite scales (on a scale of 0-100 mm where 0 is associated with lower ratings and 100 with higher ratings) following the test breakfast and lunch
Measured: Baseline and 4 weeks
Change in fuel oxidation during the test breakfast
Fat and carbohydrate oxidation following breakfast
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start26 Feb 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised to one of 3 intervention arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Betts, University of Bath
- Investigators
- Harry A Smith, MSci, Principal investigator, University of BathJames A Betts, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417205
- Sponsor's protocol ID
- DC-I
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leidy HJ, Ortinau LC, Douglas SM, Hoertel HA. Beneficial effects of a higher-protein breakfast on the appetitive, hormonal, and neural signals controlling energy intake regulation in overweight/obese, "breakfast-skipping," late-adolescent girls. Am J Clin Nutr. 2013 Apr;97(4):677-88. doi: 10.3945/ajcn.112.053116. Epub 2013 Feb 27.
PubMed 23446906Bray GA, Redman LM, de Jonge L, Covington J, Rood J, Brock C, Mancuso S, Martin CK, Smith SR. Effect of protein overfeeding on energy expenditure measured in a metabolic chamber. Am J Clin Nutr. 2015 Mar;101(3):496-505. doi: 10.3945/ajcn.114.091769. Epub 2015 Jan 14.
PubMed 25733634Park YM, Heden TD, Liu Y, Nyhoff LM, Thyfault JP, Leidy HJ, Kanaley JA. A high-protein breakfast induces greater insulin and glucose-dependent insulinotropic peptide responses to a subsequent lunch meal in individuals with type 2 diabetes. J Nutr. 2015 Mar;145(3):452-8. doi: 10.3945/jn.114.202549. Epub 2014 Dec 24.
PubMed 25733459Chowdhury EA, Richardson JD, Holman GD, Tsintzas K, Thompson D, Betts JA. The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults. Am J Clin Nutr. 2016 Mar;103(3):747-56. doi: 10.3945/ajcn.115.122044. Epub 2016 Feb 10.
PubMed 26864365Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
PubMed 24898233
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolating and Exploiting the Mechanisms That Link Breakfast and Human Health - Intervention
- ClinicalTrials.gov ID
- NCT04417205
- Acronym / sponsor ID
- DC-I
- Conditions
- Physical Activity, Postprandial Metabolism, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 4 Jun 2020 (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.
Following the establishment of causal links between breakfast consumption, the individual components of energy balance, and health it is now important to examine and target the underlying biological mechanisms involved to maximise potential health benefits.
To begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to take part in phase I (acute design) of a wider project.
Detailed description
Causal links between breakfast consumption, the individual components of energy balance, and health have recently been established and it is now important to examine and target the underlying biological mechanisms over a longer period of time to maximise potential health benefits.
Specifically, the substitution of a portion of carbohydrate for protein at breakfast may enhance the potential health benefits of breakfast through targeting distinct mechanistic pathways. Broadly, introducing a greater protein load at breakfast increases insulin secretion and delays gastric emptying, thereby eliciting a potentiated insulin response. In turn this may therefore improve glucose tolerance during a subsequent meal. Additionally, maintenance of euglycaemia following breakfast consumption, coupled with the thermic effect of feeding protein may accentuate the elevated energy expenditure following breakfast observed in previous studies. Finally, both the physical and chemical properties of protein exert a marked satiating effect. Collectively, these mechanisms could interact to maximise the net impact of breakfast on energy balance and associated health outcomes. However, whilst the evidence indicates obvious benefits of feeding a higher protein dose at breakfast, relatively little research has focused on the response to protein over multiple meals/days. Furthermore, and importantly, the mechanisms involved in the second-meal phenomenon and the potential for initial meals of varied composition to target these mechanisms have never been systematically investigated.
To begin investigating the outlined mechanisms healthy, non-obese participants will be recruited to undergo a 4 week intervention study in which they will consume one of three breakfasts for 28-days. The breakfast interventions provide will be:
Carbohydrate rich breakfast
Whey protein enriched breakfast
Extended morning fast
Participants will undergo 7 days of habitual physical activity and diet monitoring prior to visiting the laboratory for their preliminary metabolic assessment in which they will consume the carbohydrate rich breakfast followed by an ad libitum meal for lunch. They will then be randomised to one of the 3 breakfast interventions for 28-days. During the 28-days weekly monitoring of physical activity and energy intake will take place in order to assess energy balance.
Upon completion of the intervention phase participants will revisit the laboratory to replicate the initial visit in which postprandial metabolism was assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomised to one of 3 intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate rich breakfast | Active comparator | Other: Carbohydrate Rich BreakfastParticipants will be provided with 28-days worth of pre-weighed carbohydrate rich breakfast materials to consume before 1000h daily. |
| Whey protein enriched breakfast | Experimental | Dietary Supplement: Whey protein enriched breakfastParticipants will be provided with 28-days worth of pre-weighed whey protein enriched rich breakfast materials to consume before 1000h daily. |
| Extended morning fast | No intervention | –Participants will be asked to remain fasted (i.e. to not consume breakfast) until 1200h daily for 28-days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Able and willing to provide informed consent and safely comply with study procedures
- Females to maintain record of regular menstrual cycle phase or contraceptive use
- No anticipated changes in diet/physical activity during the study (e.g. holidays or diet plans)
Key exclusion criteria (5 listed)
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
- Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment (e.g. smoking/substance abuse)
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (± 3%)
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 |
|---|---|---|
| Carbohydrate Rich BreakfastParticipants will be asked to consume the provided carbohydrate rich breakfast before 1000h daily for 28 days. | Other | Carbohydrate rich breakfast |
| Whey protein enriched breakfastParticipants will be asked to consume the provided whey protein enriched breakfast before 1000h daily for 28 days. | Dietary supplement | Whey protein enriched breakfast |
Primary outcome
Change in physical activity thermogenesis
Time frame: Assessed for 1 week at baseline, 3 days a week during weeks 1-3 of the intervention and again for 1 week in the 4th week of the intervention.
Energy expenditure measured using physical activity monitor
Change in expression of circadian clock genes measured in whole blood
Time frame: Baseline and 4-weeks
Pre and post intervention change clock gene expression
Change in postprandial glycaemia following carbohydrate rich test breakfast and lunch over 4 weeks
Time frame: Baseline and 4-weeks
The postprandial time course response of plasma glucose to the test breakfast and lunch meals
Change in postprandial insulinaemia following carbohydrate rich test breakfast and lunch over 4 weeks
Time frame: Assessed at baseline and after 4 weeks of the intervention
The postprandial time course response of plasma insulin to the test breakfast and lunch meals
Change in body mass
Time frame: 4 weeks
Participants will be weighed prior to the intervention and again upon completion
3 secondary outcomes
Change in postprandial incretin hormone response following breakfast and lunch
Time frame: Baseline and 4 weeks
Change in subjective appetite ratings following breakfast and lunch
Time frame: Baseline and 4 weeks
Change in fuel oxidation during the test breakfast
Time frame: Baseline and 4 weeks
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 18 Apr 2023.
- Background: PubMed 23446906Leidy HJ, Ortinau LC, Douglas SM, Hoertel HA. Beneficial effects of a higher-protein breakfast on the appetitive, hormonal, and neural signals controlling energy intake regulation in overweight/obese, "breakfast-skipping," late-adolescent girls. Am J Clin Nutr. 2013 Apr;97(4):677-88. doi: 10.3945/ajcn.112.053116. Epub 2013 Feb 27.
- Background: PubMed 25733634Bray GA, Redman LM, de Jonge L, Covington J, Rood J, Brock C, Mancuso S, Martin CK, Smith SR. Effect of protein overfeeding on energy expenditure measured in a metabolic chamber. Am J Clin Nutr. 2015 Mar;101(3):496-505. doi: 10.3945/ajcn.114.091769. Epub 2015 Jan 14.
- Background: PubMed 25733459Park YM, Heden TD, Liu Y, Nyhoff LM, Thyfault JP, Leidy HJ, Kanaley JA. A high-protein breakfast induces greater insulin and glucose-dependent insulinotropic peptide responses to a subsequent lunch meal in individuals with type 2 diabetes. J Nutr. 2015 Mar;145(3):452-8. doi: 10.3945/jn.114.202549. Epub 2014 Dec 24.
- Background: PubMed 26864365Chowdhury EA, Richardson JD, Holman GD, Tsintzas K, Thompson D, Betts JA. The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults. Am J Clin Nutr. 2016 Mar;103(3):747-56. doi: 10.3945/ajcn.115.122044. Epub 2016 Feb 10.
- Background: PubMed 24898233Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
- Individual participant dataSharing planned: Undecided
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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.
Harry A Smith, MSci principal investigator
University of Bath
James A Betts, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Rich Breakfast and Whey protein enriched breakfast in people with Physical Activity and Postprandial Metabolism, run by University of Bath 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 6 inclusion and 5 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 18 Apr 2023. 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?
Change in physical activity thermogenesis (time frame: Assessed for 1 week at baseline, 3 days a week during weeks 1-3 of the intervention and again for 1 week in the 4th week of the intervention.). The study lists 5 primary outcomes in all. 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 NCT04417205, which also lists 5 linked publications.
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 18 Apr 2023.