- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04476693
Metabolic Responses to Breakfast in Adolescent Girls
Metabolic Responses to Breakfast Consumption Versus Omission in Adolescent Girls
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bedfordshire
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Bedford, Bedfordshire, United Kingdom, MK41 9EA
- University of Bedfordshire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 11 to 14 years old
- Female
- Healthy weight Body Mass Index centile (between the 3rd and 91st centile - Cole et al 2000)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breakfast Consumption (BC)
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. |
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.
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|
Experimental: Breakfast omission (BO)
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. |
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)].
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-lunch area under the curve (AUC) for glucose.
Time Frame: 2 hours
|
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.
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2 hours
|
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Total trial area under the curve (AUC) for glucose.
Time Frame: 5 hours
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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.
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5 hours
|
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Post-lunch area under the curve (AUC) for insulin.
Time Frame: 2 hours
|
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.
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2 hours
|
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Total trial area under the curve (AUC) for insulin.
Time Frame: 5 hours
|
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.
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5 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-lunch resting substrate oxidation
Time Frame: 2 hours
|
Substrate oxidation (fat and carbohydrate) rates will be estimated using indirect calorimetry from expired air samples at four time points following lunch (30, 60, 90 and 120 minutes).
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2 hours
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Total trial resting substrate oxidation.
Time Frame: 5 hours
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Substrate oxidation (fat and carbohydrate) rates will be estimated using indirect calorimetry from expired air samples at baseline and at 4 time points after breakfast (30, 60, 120 and 180 minutes) and 4 time points following lunch (30, 60, 90 and 120 minutes).
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5 hours
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Maximum fat oxidation rate during exercise
Time Frame: During exercise (approximately 30 minutes)
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An incremental 7-stage cycling test will be performed 2 hours after lunch for the determination of maximum fat oxidation.
Each stage will last 4 minutes in duration, where participants will keep a steady pedalling rate of 60 revolutions per minute.
The intensity for each stage was calculated based on the percentage (0%, 20%, 30%, 40%, 50%, 60%, 70%) of the theoretical maximal aerobic power.
Fat oxidation rates will be estimated during the final minute of each stage using indirect calorimetry.
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During exercise (approximately 30 minutes)
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Fatmax during exercise
Time Frame: During exercise (approximately 30 minutes)
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An incremental 7-stage cycling test will be performed 2 hours after lunch for the determination of maximum fat oxidation.
Each stage will last 4 minutes in duration, where participants will keep a steady pedalling rate of 60 revolutions per minute.
The intensity for each stage was calculated based on the percentage (0%, 20%, 30%, 40%, 50%, 60%, 70%) of the theoretical maximal aerobic power.
Fat oxidation rates will be estimated during the final minute of each stage using indirect calorimetry.
The intensity at which maximum fat oxidation occurs will be defined as Fatmax.
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During exercise (approximately 30 minutes)
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Physical activity enjoyment
Time Frame: Following exercise (approximately 5-10 minutes post)
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Physical activity enjoyment measured using Physical Activity Enjoyment Scale (PACES) during the Fatmax incremental exercise test.
The scale is composed of 16 statements (9 positive and 7 negative) which begin with the phrase "When I am physically active…".
The participants must answer by giving an answer from 1 "disagree a lot" to 5 "agree a lot" to each statement.
The average score of the positive statements is calculated to be used in the analysis.
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Following exercise (approximately 5-10 minutes post)
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Post-lunch area under the curve (AUC) for triaclyglycerol
Time Frame: 2 hour
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Net incremental AUC and total AUC for the 2-hour period post lunch in each condition will be calculated for plasma triaclyglycerol.
Five finger prick blood samples will be taken at 15, 30, 60, 90 and 120 minutes post lunch.
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2 hour
|
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Total trial area under the curve (AUC) for triaclyglycerol
Time Frame: 5 hours
|
Net incremental AUC and total AUC for the 5-hour entire trial period in each condition will be calculated for plasma triacylglycerol.
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.
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5 hours
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBedfordshire
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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