The Influence of Breakfast on Hormone Responses and Cognitive Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2019-01-01

Brief Summary

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The purpose of this study is to see what effect skipping breakfast versus consuming breakfast has on cognitive performance and the hormones responsible for glucose homeostasis in lean and obese adolescent males. The subjects will be tested on their ability to maintain attention when given several tasks called continuous temporal expectancy tasks (CTET) and electrophysiological signals using electroencephalogram (EEG) will be monitored. These two study groups will be randomized to one of two orders: (A,B) or (B,A) where A = breakfast intervention and B = no breakfast. There will be a washout period of 7 days in between study visits.

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Detailed Description

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Eating unhealthy foods and not exercising regularly contributes to obesity in children. Other unhealthy behaviors, such as skipping meals can also lead to obesity. Breakfast is known to be the most important meal of the day, yet many people skip breakfast. Skipping breakfast can cause an imbalance in the hormones that control blood glucose.

Skipping breakfast can affect how well insulin works at lowering blood glucose at later meal times. The impact of breakfast on glucose homeostasis is different from that of lunch and dinner. This became evident when a group of researchers studied the effect of skipping breakfast on hormone responses after subsequent isocaloric lunch and dinner in adults with Type 2 diabetes. The study showed that in Type 2 diabetics, skipping breakfast leads to increased post-prandial hyperglycemia and decreased glucagon-like peptide-1 (GLP-1) release, impairing the insulin response to hyperglycemia. Plasma free fatty acids (FFA) levels were found to be significantly higher after lunch and dinner when breakfast was omitted. It has been shown that acute elevation of FFA induces hepatic insulin resistance and increased hepatic glucose production in patients with Type 2 Diabetes Mellitus and in non-diabetic controls. Impaired insulin secretion can predispose to conditions such as obesity, and other diseases.

Skipping breakfast can also have a negative effect on children's ability to keep focus and attention. The CTET is a tool that can be used to directly measure attention using an EEG and is a highly sensitive measure of neural processing.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lean males

This is a randomized, two-period, cross over design with the intervention of consuming breakfast versus fasting for breakfast to study the effects on hormone responses and cognitive function using CTET in lean and obese male adolescents. These two study groups will be randomized to one of two orders:: (A,B) or (B,A) where A = Yes breakfast and B=No breakfast

Group Type EXPERIMENTAL

A= Yes Breakfast

Intervention Type OTHER

Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when given breakfast and lunch

B=No Breakfast

Intervention Type OTHER

Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when breakfast is skipped and lunch is provided.

Obese males

This is a randomized, two-period, cross over design with the intervention of consuming breakfast versus fasting for breakfast to study the effects on hormone responses and cognitive function using CTET in lean and obese male adolescents. These two study groups will be randomized to one of two orders:: (A,B) or (B,A) where A = Yes breakfast and B=No breakfast

Group Type EXPERIMENTAL

A= Yes Breakfast

Intervention Type OTHER

Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when given breakfast and lunch

B=No Breakfast

Intervention Type OTHER

Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when breakfast is skipped and lunch is provided.

Interventions

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A= Yes Breakfast

Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when given breakfast and lunch

Intervention Type OTHER

B=No Breakfast

Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when breakfast is skipped and lunch is provided.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Healthy males
2. No history of neurological or psychiatric illness, including major depressive disorder and attention deficit disorder.
3. Normal or corrected vision using the Snellen chart
4. Normal hearing
5. BMI greater than or equal to 95th percentile according to the Center for Disease Control and Prevention (CDC) growth charts
6. HbA1C less than or equal to 5.6%
7. Hemoglobin level of greater or equal to 12g/dL

Exclusion Criteria

1. History of chronic illness and chronic use of medications that affect cognitive or glucose metabolism
2. History of substance, nicotine or alcohol dependence as assessed by CRAFFT (CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE) questionnaire
3. History of eating disorder as assessed by the SCOFF questionnaire.
4. Developmental delay
5. Hearing and vision problems as assessed by the Snellen chart
6. Previous history of bariatric surgery
7. Currently taking supplements or medications indicated for weight loss
8. Previous history of head injury associated with loss of consciousness for several minutes
9. History of Epilepsy
10. Allergy to any of the foods used for the test breakfasts

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes