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Postprandial HyperglycemiaNCT05000944

Is Mid-morning Breakfast as Healthy as Early-morning Breakfast for Blood Sugar Control in Adolescent Girls?

A study testing breakfast omission (BO), early-morning breakfast consumption (EM-BC) and mid-morning breakfast consumption (MM-BC) in people with Postprandial Hyperglycemia, run by Loughborough University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Repeated, elevated levels of glucose (sugar) within the blood after eating can lead to type 2 diabetes. In adults, eating breakfast lowers blood glucose responses to subsequent meals when compared with skipping breakfast. Yet, adolescent girls may respond differently due to differences in how their bodies use energy. 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 omission (BO), early-morning breakfast consumption (EM-BC) and mid-morning breakfast consumption (MM-BC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
18 Nov 2021to 13 Jul 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 11 to 14 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Girls classified habitual breakfast skippers (using a proposed definition of 'breakfast', the girls will be classified as habitual breakfast skipper if they consume breakfast 0-3 times per week)
  • no health issues that could be affected by study participation (e.g., food allergies)
  • no extreme dislikes of the test meals.

Who cannot join

  • Medical conditions or current medication that affects glucose metabolism
  • Food allergies that would prevent consumption of prescribed meals

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Local schools

    Loughborough

Other trials in United Kingdom

About this study

Official title: Impact of Breakfast Consumption Timing on Postprandial Glycaemia and Insulinaemia in Adolescent Girls Who Habitually Skip Breakfast

Repeated, elevated levels of glucose (sugar) within the blood after eating can lead to type 2 diabetes. In adults, eating breakfast lowers blood glucose responses to subsequent meals when compared with skipping breakfast. Yet, adolescent girls may respond differently due to differences in how their bodies use energy. This is important because around 80% of the United Kingdom (UK) adolescent girls skip breakfast. As common reasons for skipping breakfast in adolescent girls are 'lack of time' and 'not hungry' in the morning, eating breakfast during the mid-morning may be an attractive option for them. This project will be the first to compare the impact of eating breakfast in the early morning and mid-morning with skipping breakfast on subsequent blood glucose levels in adolescent girls who usually skip breakfast. The findings will inform recommendations tailored to an 'at risk' and under-researched population for type 2 diabetes prevention, which is more effective than a cure.

Read the detailed description

Dietary manipulations that can moderate postprandial glycaemia and insulinaemia are at the cornerstone of type 2 diabetes (T2D) prevention. Indeed, repeated glycaemic excursions cause oxidative stress, inflammation, and atherosclerosis, increasing T2D risk. Adolescence is a critical time to promote dietary behaviours that can be sustained across the lifespan. Among the dietary factors influencing postprandial glycaemia, the decline in breakfast consumption during adolescence in girls is of concern, with only ~20% of UK adolescent girls consuming breakfast daily. Cross-sectional and prospective observational studies show that infrequent breakfast consumption is associated with T2D risk markers (e.g., glucose, insulin) in adolescents and T2D manifestation in adults. Randomised controlled trials in adults suggest that improvements in glycaemic control and insulin sensitivity may be key to explaining the reduced T2D risk when contrasting breakfast consumption with breakfast omission. Acutely, breakfast omission exaggerates glycaemic and insulinaemic responses to subsequent meals when compared to breakfast consumption, which has been termed the 'second-meal effect'. Thus, two moderate glycaemic responses (with breakfast and lunch) would be potentially better for reducing T2D risk than one very large glycaemic excursion (after lunch). Yet, findings based on adults may not apply to the distinct hormonal and metabolic profiles of adolescent girls. Specifically, it is proposed that the 'second-meal effect' occurs due to increased glucose conversion into muscle glycogen in adults. Such responses may differ in adolescents due to their higher reliance on exogenous glucose and fat as fuels with a lower reliance on endogenous glucose and reduced capacity for muscle glycogen storage, in addition to the 32% reduction in insulin sensitivity occurring from pre- to mid-puberty. Unfortunately, current knowledge on breakfast and glycaemia in adolescents relies entirely on a few novel studies that have pooled data from 13 to 20 year olds with little consideration of pubertal status and sex. Hence, the glycaemic responses to breakfast manipulation in adolescent girls are not still well understood. Common barriers to consuming breakfast among adolescent girls include not being hungry and a lack of time in the morning. As such, the option to consume breakfast later in the morning may be an attractive alternative for this population. In terms of timing, definitions have proposed that breakfast is consumed within 2-3 hours of waking, typically no later than 10:00. Yet, inconsistent definitions have been employed across the literature, mainly because evidence to inform a health-based (e.g., focused on glycaemic improvements) breakfast timing 'cut-off' is lacking. Thus, the unique contribution of this proposal is the use of an experimental cross-over design to directly contrast the effects of consuming an early-morning versus mid-morning standardised breakfast with breakfast omission on postprandial glycaemia and insulinaemia in adolescent girls classified as habitual breakfast skippers. By focusing on adolescent girls, breakfast timing and postprandial glycaemia, this proposal is unique, topical and has potential impact for T2D prevention.

Recruitment:

Girls will be recruited from local schools after gaining parental informed consent and child assent. These schools have expressed an interest in facilitating recruitment for the proposed research by providing a platform to invite girls to participate and permission for time off school to complete the measures. The participants will be invited to attend an assembly at their school and those that wish to discuss their participation with a parent/primary caregiver will take an information pack home that includes written details of the study. On return of a contact form, students and their primary caregiver will be asked to complete the consent, assent and pre-participation health screen questionnaire, before registration on the study.

Experimental design:

This study will employ a cross-over design. Participants will complete three conditions assigned according to the Latin square method: breakfast omission (BO), early-morning breakfast consumption (EM-BC) and mid-morning breakfast consumption (MM-BC). The conditions will be conducted ~7 days apart in girls who have not started their menses or in the early-follicular phase (~28 days apart) in girls with regular menses to minimise the potential confounding influence of menstrual cycle phase. In the 48 hours before the conditions, dietary intakes, bed time and wake/out of bed times will be replicated, and vigorous physical activity will be minimised (as confirmed via accelerometry).

After an overnight fast, resting metabolic rate (RMR) and substrate oxidation will be estimated via expired air analysis, and a capillary blood sample for the measurement of plasma glucose and insulin will be taken (~08:15 to 08:30). These measures will be collected at regular intervals, with a standardised lunch consumed at 4 h (~12:30) and followed by a 2-h lunch postprandial period. The standardised breakfast will be provided immediately after fasting measures at ~08:30 for EM-BC and 2 hours later at ~10:30 for MM-BC. Participants will remain sedentary throughout. Water intake will be replicated between the conditions.

Test meals:

A carbohydrate-rich, low glycaemic index (GI) breakfast providing ~70% carbohydrate, ~17% fat and ~13% protein will be used. The breakfast will be provided in quantities containing 0.04 g carbohydrate per kcal of individualised daily RMR. The standardised lunch providing 0.05 g of carbohydrate per kcal of daily RMR will be based on high GI carbohydrate. Meal consumption time will be limited to 15 minutes and replicated between the conditions.

Data and statistical analyses:

Pre-lunch (4 hours) and post-lunch (2 hours) incremental (iAUC) and total (tAUC) area under the curve will be calculated using the trapezium rule for the primary outcomes, plasma glucose and insulin. and the secondary outcomes, resting energy expenditure and substrate oxidation rates. In addition, peak plasma glucose concentration after lunch will be determined.

Linear mixed models will be used to compare all outcome variables between the conditions. Models will include fixed effects for condition (and time for the condition by time analyses) and a random intercept for participants, and will be adjusted for the order effect. The Holm-Bonferroni correction for multiple comparisons will be applied. Normality will be checked using Shapiro Wilk tests. Statistical significance will be accepted at p≤0.05. Cohen's effect sizes will be used to gauge the magnitude of differences.

Sample size estimation:

Based on 80% power at an alpha level of p=0.05, it is estimated that 21 breakfast skipping adolescent girls are required to detect a meaningful between-condition difference (Cohen's f=0.36) in post-lunch plasma glucose area under the curve. Recruitment will target 27 participants across the two study sites to account for an expected 20% attrition rate.

Being tested
breakfast omission (BO), early-morning breakfast consumption (EM-BC), mid-morning breakfast consumption (MM-BC)
Keywords
Breakfast, Meal Time, Blood Glucose, Blood Insulin, Adolescents
Medical subject headings
Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • breakfast omission (BO)Other

    Also called skipping breakfast

    this group will not be provided with a breakfast until lunch time (at 12:30).

  • early-morning breakfast consumption (EM-BC)Other

    Also called early breakfast

    this group will be provided with an early morning breakfast (at 08:30).

  • mid-morning breakfast consumption (MM-BC)Other

    Also called late breakfast

    this group will be provided with a mid (late) morning breakfast (at 10:30).

Study groups in NCT05000944
Study groupRoleWhat they receive
breakfast omission (BO)ExperimentalNo breakfast will be provided until the lunch time at ~12:30. Blood samples will be taken at fasting state and postprandially at different intervals after breakfast and lunch for the measurement of glucose and insulin concentrations.
Receives: Other: breakfast omission (BO)
early-morning breakfast consumption (EM-BC)ExperimentalA standardised, carbohydrate-rich, low glycaemic index (GI) breakfast will be provided at ~08:30 for EM-BC. Blood samples will be taken at fasting state and postprandially at different intervals after breakfast and lunch for the measurement of glucose and insulin concentrations.
Receives: Other: early-morning breakfast consumption (EM-BC)
mid-morning breakfast consumption (MM-BC).ExperimentalA standardised, carbohydrate-rich, low glycaemic index (GI) breakfast will be provided at ~10:30 for MM-BC (i.e., two hours after EM-BC). Blood samples will be taken at fasting state and postprandially at different intervals after breakfast and lunch for the measurement of glucose and insulin concentrations.
Receives: Other: mid-morning breakfast consumption (MM-BC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incremental and total area under the curve for glucose

    Blood samples will be collected at fasting and at different intervals before and after lunch meal. [Glucose] will be used to calculate 4 hours pre-lunch and 2 hours post-lunch incremental (IAUC) and total (TAUC) area under the curve using the trapezium rule.

    Measured: 4 hours before lunch and 2 hours after lunch

  2. Incremental and total area under the curve for insulin

    Blood samples will be collected at fasting and at different intervals before and after lunch meal. [Insulin] will be used to calculate 4 hours pre-lunch and 2 hours post-lunch incremental (IAUC) and total (TAUC) area under the curve using the trapezium rule.

    Measured: 4 hours before lunch and 2 hours after lunch

  3. Post-lunch peak plasma glucose concentration

    The highest plasma glucose concentration value during 2 hours after lunch will be determined and compared between breakfast conditions

    Measured: 2 hours after lunch

Secondary outcomes (2)
  1. Substrate oxidation rates

    Expired gas will be collected to calculate the rates of substrate oxidation

    Measured: 4 hours before lunch and 2 hours after lunch

  2. Resting energy expenditure

    Expired gas will be collected to calculate the resting energy expenditure

    Measured: 4 hours before lunch and 2 hours after lunch

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start18 Nov 2021
  3. Primary completion13 Jul 2022
  4. Study completion13 Jul 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
same participants will complete three breakfast conditions
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05000944
Sponsor's protocol ID
3129
Status last verified
Oct 2023
First submitted
30 Jul 2021
Last updated
5 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Balk EM, Earley A, Raman G, Avendano EA, Pittas AG, Remington PL. Combined Diet and Physical Activity Promotion Programs to Prevent Type 2 Diabetes Among Persons at Increased Risk: A Systematic Review for the Community Preventive Services Task Force. Ann Intern Med. 2015 Sep 15;163(6):437-51. doi: 10.7326/M15-0452.

    PubMed 26167912
  • Dyson PA, Kelly T, Deakin T, Duncan A, Frost G, Harrison Z, Khatri D, Kunka D, McArdle P, Mellor D, Oliver L, Worth J; Diabetes UK Nutrition Working Group. Diabetes UK evidence-based nutrition guidelines for the prevention and management of diabetes. Diabet Med. 2011 Nov;28(11):1282-8. doi: 10.1111/j.1464-5491.2011.03371.x.

    PubMed 21699560
  • Heine RJ, Balkau B, Ceriello A, Del Prato S, Horton ES, Taskinen MR. What does postprandial hyperglycaemia mean? Diabet Med. 2004 Mar;21(3):208-13. doi: 10.1111/j.1464-5491.2004.01149.x.

    PubMed 15008828
  • Todd AS, Street SJ, Ziviani J, Byrne NM, Hills AP. Overweight and obese adolescent girls: the importance of promoting sensible eating and activity behaviors from the start of the adolescent period. Int J Environ Res Public Health. 2015 Feb 17;12(2):2306-29. doi: 10.3390/ijerph120202306.

    PubMed 25690003
  • Corder K, van Sluijs EM, Ridgway CL, Steele RM, Prynne CJ, Stephen AM, Bamber DJ, Dunn VJ, Goodyer IM, Ekelund U. Breakfast consumption and physical activity in adolescents: daily associations and hourly patterns. Am J Clin Nutr. 2014 Feb;99(2):361-8. doi: 10.3945/ajcn.111.027607. Epub 2013 Nov 27.

    PubMed 24284440
  • Timlin MT, Pereira MA, Story M, Neumark-Sztainer D. Breakfast eating and weight change in a 5-year prospective analysis of adolescents: Project EAT (Eating Among Teens). Pediatrics. 2008 Mar;121(3):e638-45. doi: 10.1542/peds.2007-1035.

    PubMed 18310183
  • Ballon A, Neuenschwander M, Schlesinger S. Breakfast Skipping Is Associated with Increased Risk of Type 2 Diabetes among Adults: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. J Nutr. 2019 Jan 1;149(1):106-113. doi: 10.1093/jn/nxy194.

    PubMed 30418612
  • Hallstrom L, Labayen I, Ruiz JR, Patterson E, Vereecken CA, Breidenassel C, Gottrand F, Huybrechts I, Manios Y, Mistura L, Widhalm K, Kondaki K, Moreno LA, Sjostrom M; HELENA Study Group. Breakfast consumption and CVD risk factors in European adolescents: the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) Study. Public Health Nutr. 2013 Jul;16(7):1296-305. doi: 10.1017/S1368980012000973. Epub 2012 Apr 12.

    PubMed 22494882
  • Smith KJ, Gall SL, McNaughton SA, Blizzard L, Dwyer T, Venn AJ. Skipping breakfast: longitudinal associations with cardiometabolic risk factors in the Childhood Determinants of Adult Health Study. Am J Clin Nutr. 2010 Dec;92(6):1316-25. doi: 10.3945/ajcn.2010.30101. Epub 2010 Oct 6.

    PubMed 20926520
  • Betts 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
  • 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 26004166
  • Chowdhury 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 26864365
  • Boisseau N, Delamarche P. Metabolic and hormonal responses to exercise in children and adolescents. Sports Med. 2000 Dec;30(6):405-22. doi: 10.2165/00007256-200030060-00003.

    PubMed 11132123
  • Jovanovic A, Leverton E, Solanky B, Ravikumar B, Snaar JE, Morris PG, Taylor R. The second-meal phenomenon is associated with enhanced muscle glycogen storage in humans. Clin Sci (Lond). 2009 Jul 2;117(3):119-27. doi: 10.1042/CS20080542.

    PubMed 19161346
  • Timmons BW, Bar-Or O, Riddell MC. Oxidation rate of exogenous carbohydrate during exercise is higher in boys than in men. J Appl Physiol (1985). 2003 Jan;94(1):278-84. doi: 10.1152/japplphysiol.00140.2002. Epub 2002 Sep 13.

    PubMed 12391100

Questions about this trial

What is this clinical trial studying?

A study testing breakfast omission (BO), early-morning breakfast consumption (EM-BC) and mid-morning breakfast consumption (MM-BC) in people with Postprandial Hyperglycemia, run by Loughborough University 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 2 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 5 Oct 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?

Incremental and total area under the curve for glucose (time frame: 4 hours before lunch and 2 hours after lunch). The study lists 3 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 NCT05000944, which also lists 24 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 5 Oct 2023.

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