Metabolic Responses to Breakfast in Adolescent Girls

NCT04476693 | Completed

• 1 other identifier: UBedfordshire
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Hyperglycemia

Keywords

cardiovascular disease; diabetes

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  5 hours

Secondary Outcomes (7)

• Post-lunch resting substrate oxidation

  2 hours

• Total trial resting substrate oxidation.

  5 hours

• Maximum fat oxidation rate during exercise

  During exercise (approximately 30 minutes)

• Fatmax during exercise

  During exercise (approximately 30 minutes)

• Physical activity enjoyment

  Following exercise (approximately 5-10 minutes post)

Study Arms (2)

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.

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.

Other: Breakfast Omission

Interventions

Breakfast consumption OTHER

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 Consumption (BC)

Breakfast Omission OTHER

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 \[milk (ml)+ orange juice (ml)\].

Breakfast omission (BO)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bedfordshire: lead
• British Nutrition Foundation: collaborator

Study Sites (1)

University of Bedfordshire

Bedford, Bedfordshire, MK41 9EA, United Kingdom

Location

MeSH Terms

Conditions

Hyperglycemia; Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Exercise Physiology

Model Details: 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).

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 20, 2020
• Study Start: October 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)