Postprandial MetabolismNCT03866720
Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute
A study testing Carbohydrate rich breakfast and Whey protein enriched breakfast in people with Postprandial Metabolism and Appetite, 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
- Postprandial Metabolism, Appetite
- 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
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2019to 17 Feb 2021
- 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 crossover 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 involved to maximised 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 take part a randomised crossover trial that will contrast the acute metabolic responses to a protein-enriched breakfast, with a carbohydrate rich breakfast, and the total omission of breakfast.
- Conditions
- Postprandial Metabolism, Appetite
- Being tested
- Carbohydrate rich breakfast, Whey protein enriched breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate rich breakfastOther
A porridge breakfast meal fed at a carbohydrate delivery rate of 7.3 mg/kJ of each participants resting metabolic rate.
Whey protein enriched breakfastDietary supplement
A porridge breakfast meal in which 15 grams of whey protein is substituted in place of carbohydrate and a small portion of fat.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate rich breakfast | Active comparator | Participants will consume a porridge breakfast that is considered in line with typical carbohydrate consumption for this meal. Receives: Other: Carbohydrate rich breakfast |
| Whey protein enriched breakfast | Experimental | Participants will consume a porridge breakfast that is considered in line with typical carbohydrate consumption for this meal. Receives: Dietary Supplement: Whey protein enriched breakfast |
| Extended morning fast | No intervention | Participants will extend their overnight fast until the ad libitum lunch is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycaemia following breakfast
The postprandial time course response of plasma glucose to each breakfast meal
Measured: Plasma glucose time course data over 3 hours following breakfast
Postprandial insulinaemia following breakfast
The postprandial time course response of plasma insulin to each breakfast meal
Measured: Plasma insulin time course data over 3 hours following breakfast
Postprandial glycaemia following ad libitum lunch
The postprandial time course response of Plasma glucose to the ad libitum lunch following each type of breakfast
Measured: Plasma glucose time course data over 2 hours following lunch
Postprandial insulinaemia following ad libitum lunch
The postprandial time course response of plasma insulin to the ad libitum lunch following each type of breakfast
Measured: Plasma insulin time course data over 2 hours following lunch
Secondary outcomes (6)
Postprandial incretin hormone response following breakfast
The postprandial time course response of plasma incretin hormones (e.g. GLP-1 \& GIP) to the each breakfast.
Measured: Plasma insulin time course data over 3 hours following breakfast
Postprandial incretin hormone response following ad libitum lunch
The postprandial time course response of plasma incretin hormones (e.g. GLP-1 \& GIP) to the ad libitum lunch following each type of breakfast
Measured: Plasma incretin time course data over 3 hours following breakfast
Subjective appetite ratings following breakfast
Ratings of appetite provided on subjective appetite scales following each type of breakfast. On a scale of 0-100mm with 0 typically being associated with lower subjective ratings and 100 being associated with higher subjective ratings.
Measured: For 3 hours following each breakfast
Subjective appetite ratings following ad libitum lunch
Ratings of appetite provided on subjective appetite scales following ad libitum lunch. On a scale of 0-100mm with 0 typically being associated with lower subjective ratings and 100 being associated with higher subjective ratings.
Measured: For 3 hours following the ad libitum lunch
Fuel oxidation following breakfast
Fat and carbohydrate oxidation following each type of breakfast
Measured: For 3 hours following breakfast
Fuel oxidation following ad libitum lunch
Fat and carbohydrate oxidation following ad libitum lunch
Measured: For 2 hours following the ad libitum lunch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start26 Feb 2019
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
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 Postprandial MetabolismStudies 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
- Crossover
- Model description
- Participants will complete 3 breakfast feeding trials in a randomised order: Typical high carbohydrate breakfast followed by an ad libitum lunch. Whey protein enriched carbohydrate followed by an ad libitum lunch. Extended morning fast followed by an ad libitum lunch.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 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
- NCT03866720
- Sponsor's protocol ID
- DC-A
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Carbohydrate-rich breakfast attenuates glycaemic, insulinaemic and ghrelin response to ad libitum lunch relative to morning fasting in lean adults. Br J Nutr. 2015 Jul 14;114(1):98-107. doi: 10.1017/S0007114515001506. Epub 2015 May 25.
PubMed 26004166Park 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 25733459Bray 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 25733634Leidy 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 23446906Smith HA, Watkins JD, Walhin JP, Gonzalez JT, Thompson D, Betts JA. Whey Protein-Enriched and Carbohydrate-Rich Breakfasts Attenuate Insulinemic Responses to an ad libitum Lunch Relative to Extended Morning Fasting: A Randomized Crossover Trial. J Nutr. 2023 Oct;153(10):2842-2853. doi: 10.1016/j.tjnut.2023.08.008. Epub 2023 Aug 7.
PubMed 37557957
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolating & Exploiting the Mechanisms That Link Breakfast to Human Health - Acute
- ClinicalTrials.gov ID
- NCT03866720
- Acronym / sponsor ID
- DC-A
- Conditions
- Postprandial Metabolism, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 7 Mar 2019 (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 crossover 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 involved to maximised 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 take part a randomised crossover trial that will contrast the acute metabolic responses to a protein-enriched breakfast, with a carbohydrate rich breakfast, and the total omission of breakfast.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will complete 3 breakfast feeding trials in a randomised order: Typical high carbohydrate breakfast followed by an ad libitum lunch. Whey protein enriched carbohydrate followed by an ad libitum lunch. Extended morning fast followed by an ad libitum lunch.
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate rich breakfast | Active comparator | Other: Carbohydrate rich breakfastParticipants will consume a porridge breakfast that is considered in line with typical carbohydrate consumption for this meal. |
| Whey protein enriched breakfast | Experimental | Dietary Supplement: Whey protein enriched breakfastParticipants will consume a porridge breakfast that is considered in line with typical carbohydrate consumption for this meal. |
| Extended morning fast | No intervention | –Participants will extend their overnight fast until the ad libitum lunch is provided. |
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 breakfastA porridge breakfast meal fed at a carbohydrate delivery rate of 7.3 mg/kJ of each participants resting metabolic rate. | Other | Carbohydrate rich breakfast |
| Whey protein enriched breakfastA porridge breakfast meal in which 15 grams of whey protein is substituted in place of carbohydrate and a small portion of fat. | Dietary supplement | Whey protein enriched breakfast |
Primary outcome
Postprandial glycaemia following breakfast
Time frame: Plasma glucose time course data over 3 hours following breakfast
The postprandial time course response of plasma glucose to each breakfast meal
Postprandial insulinaemia following breakfast
Time frame: Plasma insulin time course data over 3 hours following breakfast
The postprandial time course response of plasma insulin to each breakfast meal
Postprandial glycaemia following ad libitum lunch
Time frame: Plasma glucose time course data over 2 hours following lunch
The postprandial time course response of Plasma glucose to the ad libitum lunch following each type of breakfast
Postprandial insulinaemia following ad libitum lunch
Time frame: Plasma insulin time course data over 2 hours following lunch
The postprandial time course response of plasma insulin to the ad libitum lunch following each type of breakfast
6 secondary outcomes
Postprandial incretin hormone response following breakfast
Time frame: Plasma insulin time course data over 3 hours following breakfast
Postprandial incretin hormone response following ad libitum lunch
Time frame: Plasma incretin time course data over 3 hours following breakfast
Subjective appetite ratings following breakfast
Time frame: For 3 hours following each breakfast
Subjective appetite ratings following ad libitum lunch
Time frame: For 3 hours following the ad libitum lunch
Fuel oxidation following breakfast
Time frame: For 3 hours following breakfast
Fuel oxidation following ad libitum lunch
Time frame: For 2 hours following the ad libitum lunch
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 4 Mar 2021.
- Background: PubMed 26004166Chowdhury EA, Richardson JD, Tsintzas K, Thompson D, Betts JA. Carbohydrate-rich breakfast attenuates glycaemic, insulinaemic and ghrelin response to ad libitum lunch relative to morning fasting in lean adults. Br J Nutr. 2015 Jul 14;114(1):98-107. doi: 10.1017/S0007114515001506. Epub 2015 May 25.
- 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 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 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.
- Derived from this study: PubMed 37557957Smith HA, Watkins JD, Walhin JP, Gonzalez JT, Thompson D, Betts JA. Whey Protein-Enriched and Carbohydrate-Rich Breakfasts Attenuate Insulinemic Responses to an ad libitum Lunch Relative to Extended Morning Fasting: A Randomized Crossover Trial. J Nutr. 2023 Oct;153(10):2842-2853. doi: 10.1016/j.tjnut.2023.08.008. Epub 2023 Aug 7.
- 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 Postprandial Metabolism and Appetite, 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 4 Mar 2021. 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?
Postprandial glycaemia following breakfast (time frame: Plasma glucose time course data over 3 hours following breakfast). The study lists 4 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 NCT03866720, 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 4 Mar 2021.