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

NCT05000944 | Completed

• 1 other identifier: 3129
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Hyperglycemia

Keywords

Breakfast; Meal Time; Blood Glucose; Blood Insulin; Adolescents

Outcome Measures

Primary Outcomes (3)

• 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.

  4 hours before lunch and 2 hours after lunch

• 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.

  4 hours before lunch and 2 hours after lunch

• 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

  2 hours after lunch

Secondary Outcomes (2)

• Substrate oxidation rates

  4 hours before lunch and 2 hours after lunch

• Resting energy expenditure

  4 hours before lunch and 2 hours after lunch

Study Arms (3)

breakfast omission (BO)

EXPERIMENTAL

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.

Other: breakfast omission (BO)

early-morning breakfast consumption (EM-BC)

EXPERIMENTAL

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.

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

mid-morning breakfast consumption (MM-BC).

EXPERIMENTAL

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.

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

Interventions

breakfast omission (BO) OTHER

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

Also known as: skipping breakfast

breakfast omission (BO)

early-morning breakfast consumption (EM-BC) OTHER

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

Also known as: early breakfast

early-morning breakfast consumption (EM-BC)

mid-morning breakfast consumption (MM-BC) OTHER

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

Also known as: late breakfast

mid-morning breakfast consumption (MM-BC).

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Loughborough University: lead
• University of Bedfordshire: collaborator

Study Sites (1)

Local schools

Loughborough, United Kingdom

Location

Related Publications (23)

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MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Keith Tolfrey, Dr

  Loughborough University

  PRINCIPAL INVESTIGATOR

• Sahar Afeef, MSc

  Loughborough University

  PRINCIPAL INVESTIGATOR

• Julia Zakrzewski-Fruer, Dr

  University of Bedfordshire

  PRINCIPAL INVESTIGATOR

• Laura Barrett, Dr

  Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: same participants will complete three breakfast conditions

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 11, 2021
• Study Start: November 18, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)