Postprandial HyperglycemiaNCT04476693
Metabolic Responses to Breakfast in Adolescent Girls
A study testing Breakfast consumption and Breakfast Omission in people with Postprandial Hyperglycemia, run by University of Bedfordshire at 1 site in United Kingdom.
Trial summary
Breakfast consumption (BC) is frequently associated with a healthy lifestyle, healthy body weight and favourable cardiometabolic health. Research from studies in adults suggests that breakfast skipping causes elevated plasma glucose and insulin concentrations after lunch. Read more about this study
- Who is it for?
- Ages 11 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Breakfast consumption and Breakfast Omission
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 1 Jul 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 11 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 11 to 14 years old
- Female
- Healthy weight Body Mass Index centile (between the 3rd and 91st centile - Cole et al 2000)
Who cannot join
- Allergies to the breakfast and lunch ingredients
- Fitted with a pacemaker
- Unable to walk
- Health related issues that could be affected by participation in the study (e.g., uncontrolled exercise-induced asthma, diabetes, epilepsy)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Bedfordshire
Bedford, Bedfordshire, MK41 9EA
About this study
Official title: Metabolic Responses to Breakfast Consumption Versus Omission in Adolescent Girls
Breakfast consumption (BC) is frequently associated with a healthy lifestyle, healthy body weight and favourable cardiometabolic health. Research from studies in adults suggests that breakfast skipping causes elevated plasma glucose and insulin concentrations after lunch. However, there is currently no evidence to suggest a similar metabolic response in adolescent girls, a population that frequently skips breakfast. The primary purpose of this study is to examine the effects of BC versus breakfast omission (BO) on metabolic responses after lunch in healthy adolescent girls.
Read the detailed description
Breakfast consumption (BC) is habitually associated with a healthy lifestyle (e.g., diet and physical activity), reduced adiposity and favourable cardiometabolic health profiles in children, adolescents and adults. Experimental research in adults has shown that breakfast consumption reduces the glycaemic and insulinemic response to lunch when compared with breakfast omission; this has been termed 'the second meal effect'. Further, breakfast consumption may improve exercise performance and increase free-living physical activity energy expenditure in adults. Understanding the postprandial metabolic responses to BC and breakfast omission (BO) in adolescent girls is particularly important, as this population frequently skips breakfast and have low physical activity levels. Yet, adolescent girls may respond differently to adults due to their distinct metabolic profiles, and past research has not targeted this population. The primary aim of this research is to examine whether BC versus BO affects postprandial glycaemic and insulinemic responses to lunch in adolescent girls. Secondly, it aims to examine the lipaemic and substrate oxidation responses during rest, substrate oxidation during an exercise bout performed later in the day, and physical activity enjoyment during the exercise bout.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Breakfast consumption, Breakfast Omission
- Keywords
- cardiovascular disease, diabetes
- Medical subject headings
- Hyperglycemia, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast consumptionOther
Consumption of breakfast: The breakfast provided was designed based on the "characteristics of an ideal breakfast" outlined in Giovannini et al., (2008). The breakfast provided in the present study will include the following: all-bran cereals (Kellogg's), semi-skimmed milk (Tesco), Royal Gala Apple (Tesco) and Orange Juice from Concentrate (Tesco) containing the amount of carbohydrates usually consumed at breakfast in the UK (Reeves et al., 2013). The portion for each participant will contain 0.06 g of carbohydrate per kcal of measured RMR. As the portion size (20% of daily calorie intake) will be calculated based on individual RMR , no leftovers will be allowed.
Breakfast OmissionOther
Omission of breakfast. Participants will consume water within 15 min, the individual volume of which will be calculated based on the liquid content of the breakfast [milk (ml)+ orange juice (ml)].
| Study group | Role | What they receive |
|---|---|---|
| Breakfast Consumption (BC) | Experimental | The consumption of a standardised breakfast followed by a standardised lunch 3-h after the last mouthful of breakfast meal. All the ingredients of the breakfast and lunch provided will be weighed, with the portion sizes calculated based on individual resting metabolic rate (RMR). The participants were instructed to consume the meals provided within 15 min. A minimum of seven days washout period will be provided to avoid carry-over effects between conditions.
The standardised lunch will consist of white bread without crust (Tesco), margarine 'Butter Me Up Spread' (Tesco), strawberry jam (Tesco), salted crisps (Walkers) and sparkling glucose drink (Lucozade Energy Original). This carbohydrate-rich high glycameic index lunch was designed to trigger quick and exaggerated glucose and insulin response. Receives: Other: Breakfast consumption |
| Breakfast omission (BO) | Experimental | Participant will consume water, the individual volume of which was calculated based on the liquid content of the breakfast. A standardised lunch will be consumed 3-h after the last mouthful of water. All the ingredients of the breakfast and lunch provided were weighed, with the portion sizes calculated based on individual resting metabolic rate (RMR). The participants were instructed to consume the meals provided within 15 min. A minimum of seven days washout period was provided to avoid carry-over effects between conditions.
The standardised lunch consists of white bread without crust (Tesco), margarine 'Butter Me Up Spread' (Tesco), strawberry jam (Tesco), salted crisps (Walkers) and sparkling glucose drink (Lucozade Energy Original). This carbohydrate-rich high glycameic index lunch was designed to trigger quick and exaggerated glucose and insulin response. Receives: Other: Breakfast Omission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-lunch area under the curve (AUC) for glucose.
Net incremental AUC and total AUC for 2-hour period post lunch in each condition will be calculated for plasma glucose. Five finger prick blood samples will be taken at 15, 30, 60, 90 and 120 minutes post lunch.
Measured: 2 hours
Total trial area under the curve (AUC) for glucose.
Net incremental AUC and total AUC for the 5-hour entire trial period in each condition will be calculated for plasma glucose. Finger prick blood samples will be taken at at 0 (baseline), 30, 60, 120 and 180 min after breakfast consumption or omission and at 15, 30, 60, 90 and 120 minutes after lunch consumption.
Measured: 5 hours
Post-lunch area under the curve (AUC) for insulin.
Net incremental AUC and totral AUC for 2-hour period post lunch in each condition will be calculated for plasma insulin. Five finger prick blood samples will be taken at 15, 30, 60, 90 and 120 minutes post lunch.
Measured: 2 hours
Total trial area under the curve (AUC) for insulin.
Net incremental AUC and total AUC for the 5-hour entire trial period in each condition will be calculated for plasma insulin. Finger prick blood samples will be taken at at 0 (baseline), 30, 60, 120 and 180 min after breakfast consumption or omission and at 15, 30, 60, 90 and 120 minutes after lunch consumption.
Measured: 5 hours
Secondary outcomes (7)
Post-lunch resting substrate oxidation
Substrate oxidation (fat and carbohydrate) rates will be estimated using indirect calorimetry from expired air samples at four time points following lunch (30, 60, 90 and 120 minutes).
Measured: 2 hours
Total trial resting substrate oxidation.
Substrate oxidation (fat and carbohydrate) rates will be estimated using indirect calorimetry from expired air samples at baseline and at 4 time points after breakfast (30, 60, 120 and 180 minutes) and 4 time points following lunch (30, 60, 90 and 120 minutes).
Measured: 5 hours
Maximum fat oxidation rate during exercise
An incremental 7-stage cycling test will be performed 2 hours after lunch for the determination of maximum fat oxidation. Each stage will last 4 minutes in duration, where participants will keep a steady pedalling rate of 60 revolutions per minute. The intensity for each stage was calculated based on the percentage (0%, 20%, 30%, 40%, 50%, 60%, 70%) of the theoretical maximal aerobic power. Fat oxidation rates will be estimated during the final minute of each stage using indirect calorimetry.
Measured: During exercise (approximately 30 minutes)
Fatmax during exercise
An incremental 7-stage cycling test will be performed 2 hours after lunch for the determination of maximum fat oxidation. Each stage will last 4 minutes in duration, where participants will keep a steady pedalling rate of 60 revolutions per minute. The intensity for each stage was calculated based on the percentage (0%, 20%, 30%, 40%, 50%, 60%, 70%) of the theoretical maximal aerobic power. Fat oxidation rates will be estimated during the final minute of each stage using indirect calorimetry. The intensity at which maximum fat oxidation occurs will be defined as Fatmax.
Measured: During exercise (approximately 30 minutes)
Physical activity enjoyment
Physical activity enjoyment measured using Physical Activity Enjoyment Scale (PACES) during the Fatmax incremental exercise test. The scale is composed of 16 statements (9 positive and 7 negative) which begin with the phrase "When I am physically active…". The participants must answer by giving an answer from 1 "disagree a lot" to 5 "agree a lot" to each statement. The average score of the positive statements is calculated to be used in the analysis.
Measured: Following exercise (approximately 5-10 minutes post)
Post-lunch area under the curve (AUC) for triaclyglycerol
Net incremental AUC and total AUC for the 2-hour period post lunch in each condition will be calculated for plasma triaclyglycerol. Five finger prick blood samples will be taken at 15, 30, 60, 90 and 120 minutes post lunch.
Measured: 2 hour
Total trial area under the curve (AUC) for triaclyglycerol
Net incremental AUC and total AUC for the 5-hour entire trial period in each condition will be calculated for plasma triacylglycerol. Finger prick blood samples will be taken at at 0 (baseline), 30, 60, 120 and 180 min after breakfast consumption or omission and at 15, 30, 60, 90 and 120 minutes after lunch consumption.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Oct 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies 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
- Two experimental trials will be completed in a randomised counterbalanced order: BC and BO. A standardised lunch will be provided three hours after breakfast consumption (BC) or after water consumption during breakfast omission (BO). Finger prick blood samples for the analysis of plasma glucose, insulin and triaclglycerol and expired gas samples for the analysis of substrate oxidation will be taken throughout the trials. An incremental cycling exercise test with 4 minute stages will be performed 2 h after lunch for the determination of maximum fat oxidation (MFO) and intensity at which MFO occurred (i.e., Fatmax). The OMNI scale will be used to evaluate the perceived exertion at the end of each cycling stage. PA enjoyment will be evaluated using Physical Activity Enjoyment Scale (PACES).
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bedfordshire
- Sponsor type
- University, hospital or other
- Collaborators
- British Nutrition Foundation
- Responsible party
- Principal investigator, Dr Rebecca Jones, University of Bedfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476693
- Sponsor's protocol ID
- UBedfordshire
- Status last verified
- Feb 2023
- First submitted
- 9 Jul 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Responses to Breakfast Consumption Versus Omission in Adolescent Girls
- ClinicalTrials.gov ID
- NCT04476693
- Acronym / sponsor ID
- UBedfordshire
- Conditions
- Postprandial Hyperglycemia
- Keywords
- cardiovascular disease, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Collaborators
- British Nutrition Foundation
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 20 Jul 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.
Breakfast consumption (BC) is frequently associated with a healthy lifestyle, healthy body weight and favourable cardiometabolic health. Research from studies in adults suggests that breakfast skipping causes elevated plasma glucose and insulin concentrations after lunch. However, there is currently no evidence to suggest a similar metabolic response in adolescent girls, a population that frequently skips breakfast. The primary purpose of this study is to examine the effects of BC versus breakfast omission (BO) on metabolic responses after lunch in healthy adolescent girls.
Detailed description
Breakfast consumption (BC) is habitually associated with a healthy lifestyle (e.g., diet and physical activity), reduced adiposity and favourable cardiometabolic health profiles in children, adolescents and adults. Experimental research in adults has shown that breakfast consumption reduces the glycaemic and insulinemic response to lunch when compared with breakfast omission; this has been termed 'the second meal effect'. Further, breakfast consumption may improve exercise performance and increase free-living physical activity energy expenditure in adults. Understanding the postprandial metabolic responses to BC and breakfast omission (BO) in adolescent girls is particularly important, as this population frequently skips breakfast and have low physical activity levels. Yet, adolescent girls may respond differently to adults due to their distinct metabolic profiles, and past research has not targeted this population. The primary aim of this research is to examine whether BC versus BO affects postprandial glycaemic and insulinemic responses to lunch in adolescent girls. Secondly, it aims to examine the lipaemic and substrate oxidation responses during rest, substrate oxidation during an exercise bout performed later in the day, and physical activity enjoyment during the exercise bout.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two experimental trials will be completed in a randomised counterbalanced order: BC and BO. A standardised lunch will be provided three hours after breakfast consumption (BC) or after water consumption during breakfast omission (BO). Finger prick blood samples for the analysis of plasma glucose, insulin and triaclglycerol and expired gas samples for the analysis of substrate oxidation will be taken throughout the trials. An incremental cycling exercise test with 4 minute stages will be performed 2 h after lunch for the determination of maximum fat oxidation (MFO) and intensity at which MFO occurred (i.e., Fatmax). The OMNI scale will be used to evaluate the perceived exertion at the end of each cycling stage. PA enjoyment will be evaluated using Physical Activity Enjoyment Scale (PACES).
| Arm | Type | Receives |
|---|---|---|
| Breakfast Consumption (BC) | Experimental | Other: Breakfast consumptionThe consumption of a standardised breakfast followed by a standardised lunch 3-h after the last mouthful of breakfast meal. All the ingredients of the breakfast and lunch provided will be weighed, with the portion sizes calculated based on individual resting metabolic rate (RMR). The participants were instructed to consume the meals provided within 15 min. A minimum of seven days washout period will be provided to avoid carry-over effects between conditions. The standardised lunch will consist of white bread without crust (Tesco), margarine 'Butter Me Up Spread' (Tesco), strawberry jam (Tesco), salted crisps (Walkers) and sparkling glucose drink (Lucozade Energy Original). This carbohydrate-rich high glycameic index lunch was designed to trigger quick and exaggerated glucose and insulin response. |
| Breakfast omission (BO) | Experimental | Other: Breakfast OmissionParticipant will consume water, the individual volume of which was calculated based on the liquid content of the breakfast. A standardised lunch will be consumed 3-h after the last mouthful of water. All the ingredients of the breakfast and lunch provided were weighed, with the portion sizes calculated based on individual resting metabolic rate (RMR). The participants were instructed to consume the meals provided within 15 min. A minimum of seven days washout period was provided to avoid carry-over effects between conditions. The standardised lunch consists of white bread without crust (Tesco), margarine 'Butter Me Up Spread' (Tesco), strawberry jam (Tesco), salted crisps (Walkers) and sparkling glucose drink (Lucozade Energy Original). This carbohydrate-rich high glycameic index lunch was designed to trigger quick and exaggerated glucose and insulin response. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 11 to 14 years old
- Female
- Healthy weight Body Mass Index centile (between the 3rd and 91st centile - Cole et al 2000)
Key exclusion criteria (4 listed)
- Allergies to the breakfast and lunch ingredients
- Fitted with a pacemaker
- Unable to walk
- Health related issues that could be affected by participation in the study (e.g., uncontrolled exercise-induced asthma, diabetes, epilepsy)
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 |
|---|---|---|
| Breakfast consumptionConsumption of breakfast: The breakfast provided was designed based on the "characteristics of an ideal breakfast" outlined in Giovannini et al., (2008). The breakfast provided in the present study will include the following: all-bran cereals (Kellogg's), semi-skimmed milk (Tesco), Royal Gala Apple (Tesco) and Orange Juice from Concentrate (Tesco) containing the amount of carbohydrates usually consumed at breakfast in the UK (Reeves et al., 2013). The portion for each participant will contain 0.06 g of carbohydrate per kcal of measured RMR. As the portion size (20% of daily calorie intake) will be calculated based on individual RMR , no leftovers will be allowed. | Other | Breakfast Consumption (BC) |
| Breakfast OmissionOmission of breakfast. Participants will consume water within 15 min, the individual volume of which will be calculated based on the liquid content of the breakfast [milk (ml)+ orange juice (ml)]. | Other | Breakfast omission (BO) |
Primary outcome
Post-lunch area under the curve (AUC) for glucose.
Time frame: 2 hours
Net incremental AUC and total AUC for 2-hour period post lunch in each condition will be calculated for plasma glucose. Five finger prick blood samples will be taken at 15, 30, 60, 90 and 120 minutes post lunch.
Total trial area under the curve (AUC) for glucose.
Time frame: 5 hours
Net incremental AUC and total AUC for the 5-hour entire trial period in each condition will be calculated for plasma glucose. Finger prick blood samples will be taken at at 0 (baseline), 30, 60, 120 and 180 min after breakfast consumption or omission and at 15, 30, 60, 90 and 120 minutes after lunch consumption.
Post-lunch area under the curve (AUC) for insulin.
Time frame: 2 hours
Net incremental AUC and totral AUC for 2-hour period post lunch in each condition will be calculated for plasma insulin. Five finger prick blood samples will be taken at 15, 30, 60, 90 and 120 minutes post lunch.
Total trial area under the curve (AUC) for insulin.
Time frame: 5 hours
Net incremental AUC and total AUC for the 5-hour entire trial period in each condition will be calculated for plasma insulin. Finger prick blood samples will be taken at at 0 (baseline), 30, 60, 120 and 180 min after breakfast consumption or omission and at 15, 30, 60, 90 and 120 minutes after lunch consumption.
7 secondary outcomes
Post-lunch resting substrate oxidation
Time frame: 2 hours
Total trial resting substrate oxidation.
Time frame: 5 hours
Maximum fat oxidation rate during exercise
Time frame: During exercise (approximately 30 minutes)
Fatmax during exercise
Time frame: During exercise (approximately 30 minutes)
Physical activity enjoyment
Time frame: Following exercise (approximately 5-10 minutes post)
Post-lunch area under the curve (AUC) for triaclyglycerol
Time frame: 2 hour
Total trial area under the curve (AUC) for triaclyglycerol
Time frame: 5 hours
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 1 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast consumption and Breakfast Omission in people with Postprandial Hyperglycemia, run by University of Bedfordshire 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 3 inclusion and 4 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 1 Mar 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?
Post-lunch area under the curve (AUC) for glucose. (time frame: 2 hours). 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?
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 1 Mar 2023.