Clinical trial NCT04476693: Metabolic Responses to Breakfast in Adolescent Girls
Official title: Metabolic Responses to Breakfast Consumption Versus Omission in Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Keywords: cardiovascular disease
diabetes
Lead sponsor: University of Bedfordshire
Sponsor class: OTHER
Collaborators: name: British Nutrition Foundation
First posted: 2020-07-20
Enrollment: 18
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 11 to 14 years old
2. Female
3. Healthy weight Body Mass Index centile (between the 3rd and 91st centile - Cole et al 2000)

Exclusion Criteria:

1. Allergies to the breakfast and lunch ingredients
2. Fitted with a pacemaker
3. Unable to walk
4. Health related issues that could be affected by participation in the study (e.g., uncontrolled exercise-induced asthma, diabetes, epilepsy)

Primary outcomes:
measure: Post-lunch area under the curve (AUC) for glucose.
timeFrame: 2 hours
measure: Total trial area under the curve (AUC) for glucose.
timeFrame: 5 hours
measure: Post-lunch area under the curve (AUC) for insulin.
timeFrame: 2 hours
measure: Total trial area under the curve (AUC) for insulin.
timeFrame: 5 hours
Secondary outcomes:
measure: Post-lunch resting substrate oxidation
timeFrame: 2 hours
measure: Total trial resting substrate oxidation.
timeFrame: 5 hours
measure: Maximum fat oxidation rate during exercise
timeFrame: During exercise (approximately 30 minutes)
measure: Fatmax during exercise
timeFrame: During exercise (approximately 30 minutes)
measure: Physical activity enjoyment
timeFrame: Following exercise (approximately 5-10 minutes post)
measure: Post-lunch area under the curve (AUC) for triaclyglycerol
timeFrame: 2 hour
measure: Total trial area under the curve (AUC) for triaclyglycerol
timeFrame: 5 hours
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: University of Bedfordshire
state: Bedfordshire
Study officials:
References: