Purpose

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.

Condition

Eligibility

Eligible Ages
Between 13 Years and 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
Yes

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 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 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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Montefiore Medical Center of Albert Einstein College of Medicine
Bronx, New York 10467
Contact:
Rubina Heptulla, MD
718-920-4664
rheptull@montefiore.org

More Details

NCT ID
NCT03005951
Status
Recruiting
Sponsor
Albert Einstein College of Medicine, Inc.

Study Contact

Jarreau Chen, M.D.
7189208193
jarchen@montefiore.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.