The Influence of Breakfast on Hormone Responses and Cognitive Performance

The Influence of Breakfast on Hormone Responses and Cognitive Performance, as Assessed by CTET in Lean and Obese Adolescent Males

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance
• Intervention / Treatment: Other: A= Yes Breakfast; Other: B=No Breakfast

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jarreau Chen, M.D.; Phone Number: 7189208193; Email: john.foxe@einsteinmed.org
• Study Contact Backup: Name: Lisa Underland, MD; Phone Number: 718.920.4664; Email: lunderla@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center of Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

The inclusion and exclusion criteria for lean subjects will be identical to that of obese subjects with the exception that the lean subjects will be less than or equal to the 85th percentile for BMI, according to CDC growth charts.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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; 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.
Experimental: 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	Other: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measurement of glucose will be euglycemic during the breakfast study visit	Area under the curve of glucose from time 0min to 420 min.	0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
The measurement of C-peptide will be steady during the breakfast study visit	Area under the curve of C-peptide from time 0min to 420 min.	0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
The measurement of insulin will be steady during the breakfast study visit	Area under the curve of insulin from time 0min to 420 min.	0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
The measurement of free fatty acids will be steady during the breakfast study visit	Area under the curve of free fatty acids from time 0min to 420 min.	0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
The measurement of glucagon-like peptide will be steady during the breakfast study visit	Area under the curve of glucagon- like peptide from time 0min to 420 min.	0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
The measurement of glucagon will be steady during the breakfast study visit	Area under the curve of glucagon from time 0min to 420 min.	0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient
The measurement of CTET will be better during the breakfast study visit	Area under the curve of CTET from time 0min to 420 min.	0min to 420 min during both during the treatment and control visits over the one year study period. Each study visit will be conducted on 2 separate days with a washout period of at least 1 week in between the study visits for each patient

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: Montefiore Medical Center; New York State Department of Health
• Investigators: Principal Investigator: Lisa Underland, MD, Albert Einstein College of Medicine. Montefiore Medical Center

Publications and helpful links

General Publications

• Jakubowicz D, Wainstein J, Ahren B, Landau Z, Bar-Dayan Y, Froy O. Fasting until noon triggers increased postprandial hyperglycemia and impaired insulin response after lunch and dinner in individuals with type 2 diabetes: a randomized clinical trial. Diabetes Care. 2015 Oct;38(10):1820-6. doi: 10.2337/dc15-0761. Epub 2015 Jul 28.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimated): December 30, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 2015-5542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No