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

Primary Purpose

Postprandial Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
breakfast omission (BO)
early-morning breakfast consumption (EM-BC)
mid-morning breakfast consumption (MM-BC)
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring Breakfast, Meal Time, Blood Glucose, Blood Insulin, Adolescents

Eligibility Criteria

11 Years - 14 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion criteria:

  • 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.

Exclusion criteria:

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

Sites / Locations

  • Local schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

breakfast omission (BO)

early-morning breakfast consumption (EM-BC)

mid-morning breakfast consumption (MM-BC).

Arm Description

No 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.

A 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.

A 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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Substrate oxidation rates
Expired gas will be collected to calculate the rates of substrate oxidation
Resting energy expenditure
Expired gas will be collected to calculate the resting energy expenditure

Full Information

First Posted
July 30, 2021
Last Updated
October 3, 2023
Sponsor
Loughborough University
Collaborators
University of Bedfordshire
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1. Study Identification

Unique Protocol Identification Number
NCT05000944
Brief Title
Is Mid-morning Breakfast as Healthy as Early-morning Breakfast for Blood Sugar Control in Adolescent Girls?
Official Title
Impact of Breakfast Consumption Timing on Postprandial Glycaemia and Insulinaemia in Adolescent Girls Who Habitually Skip Breakfast
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
University of Bedfordshire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
Keywords
Breakfast, Meal Time, Blood Glucose, Blood Insulin, Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
same participants will complete three breakfast conditions
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
breakfast omission (BO)
Arm Type
Experimental
Arm Description
No 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.
Arm Title
early-morning breakfast consumption (EM-BC)
Arm Type
Experimental
Arm Description
A 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.
Arm Title
mid-morning breakfast consumption (MM-BC).
Arm Type
Experimental
Arm Description
A 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.
Intervention Type
Other
Intervention Name(s)
breakfast omission (BO)
Other Intervention Name(s)
skipping breakfast
Intervention Description
this group will not be provided with a breakfast until lunch time (at 12:30).
Intervention Type
Other
Intervention Name(s)
early-morning breakfast consumption (EM-BC)
Other Intervention Name(s)
early breakfast
Intervention Description
this group will be provided with an early morning breakfast (at 08:30).
Intervention Type
Other
Intervention Name(s)
mid-morning breakfast consumption (MM-BC)
Other Intervention Name(s)
late breakfast
Intervention Description
this group will be provided with a mid (late) morning breakfast (at 10:30).
Primary Outcome Measure Information:
Title
Incremental and total area under the curve for glucose
Description
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.
Time Frame
4 hours before lunch and 2 hours after lunch
Title
Incremental and total area under the curve for insulin
Description
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.
Time Frame
4 hours before lunch and 2 hours after lunch
Title
Post-lunch peak plasma glucose concentration
Description
The highest plasma glucose concentration value during 2 hours after lunch will be determined and compared between breakfast conditions
Time Frame
2 hours after lunch
Secondary Outcome Measure Information:
Title
Substrate oxidation rates
Description
Expired gas will be collected to calculate the rates of substrate oxidation
Time Frame
4 hours before lunch and 2 hours after lunch
Title
Resting energy expenditure
Description
Expired gas will be collected to calculate the resting energy expenditure
Time Frame
4 hours before lunch and 2 hours after lunch

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: Medical conditions or current medication that affects glucose metabolism Food allergies that would prevent consumption of prescribed meals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Tolfrey, Dr
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sahar Afeef, MSc
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia Zakrzewski-Fruer, Dr
Organizational Affiliation
University of Bedfordshire
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Barrett, Dr
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local schools
City
Loughborough
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
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Is Mid-morning Breakfast as Healthy as Early-morning Breakfast for Blood Sugar Control in Adolescent Girls?

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