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The Influence of Breakfast on Hormone Responses and Cognitive Performance

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A= Yes Breakfast
B=No Breakfast
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance

Eligibility Criteria

13 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Montefiore Medical Center of Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lean males

Obese males

Arm Description

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

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

Outcomes

Primary Outcome Measures

The measurement of glucose will be euglycemic during the breakfast study visit
Area under the curve of glucose from time 0min to 420 min.
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.
The measurement of insulin will be steady during the breakfast study visit
Area under the curve of insulin from time 0min to 420 min.
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.
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.
The measurement of glucagon will be steady during the breakfast study visit
Area under the curve of glucagon from time 0min to 420 min.
The measurement of CTET will be better during the breakfast study visit
Area under the curve of CTET from time 0min to 420 min.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2016
Last Updated
August 23, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
New York State Department of Health, Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03005951
Brief Title
The Influence of Breakfast on Hormone Responses and Cognitive Performance
Official Title
The Influence of Breakfast on Hormone Responses and Cognitive Performance, as Assessed by CTET in Lean and Obese Adolescent Males
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
New York State Department of Health, Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lean males
Arm Type
Experimental
Arm Description
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
Arm Title
Obese males
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
A= Yes Breakfast
Intervention Description
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
Intervention Name(s)
B=No Breakfast
Intervention Description
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.
Primary Outcome Measure Information:
Title
The measurement of glucose will be euglycemic during the breakfast study visit
Description
Area under the curve of glucose from time 0min to 420 min.
Time Frame
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
Title
The measurement of C-peptide will be steady during the breakfast study visit
Description
Area under the curve of C-peptide from time 0min to 420 min.
Time Frame
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
Title
The measurement of insulin will be steady during the breakfast study visit
Description
Area under the curve of insulin from time 0min to 420 min.
Time Frame
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
Title
The measurement of free fatty acids will be steady during the breakfast study visit
Description
Area under the curve of free fatty acids from time 0min to 420 min.
Time Frame
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
Title
The measurement of glucagon-like peptide will be steady during the breakfast study visit
Description
Area under the curve of glucagon- like peptide from time 0min to 420 min.
Time Frame
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
Title
The measurement of glucagon will be steady during the breakfast study visit
Description
Area under the curve of glucagon from time 0min to 420 min.
Time Frame
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
Title
The measurement of CTET will be better during the breakfast study visit
Description
Area under the curve of CTET from time 0min to 420 min.
Time Frame
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy males No history of neurological or psychiatric illness, including major depressive disorder and attention deficit disorder. Normal or corrected vision using the Snellen chart Normal hearing BMI greater than or equal to 95th percentile according to the Center for Disease Control and Prevention (CDC) growth charts HbA1C less than or equal to 5.6% Hemoglobin level of greater or equal to 12g/dL Exclusion Criteria: History of chronic illness and chronic use of medications that affect cognitive or glucose metabolism History of substance, nicotine or alcohol dependence as assessed by CRAFFT (CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE) questionnaire History of eating disorder as assessed by the SCOFF questionnaire. Developmental delay Hearing and vision problems as assessed by the Snellen chart Previous history of bariatric surgery Currently taking supplements or medications indicated for weight loss Previous history of head injury associated with loss of consciousness for several minutes History of Epilepsy 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Underland, MD
Organizational Affiliation
Albert Einstein College of Medicine Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center of Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26220945
Citation
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.
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The Influence of Breakfast on Hormone Responses and Cognitive Performance

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