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The Influence of Breakfast on Hormone Responses and Cognitive Performance

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ClinicalTrials.gov Identifier: NCT03005951
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : March 6, 2018
Sponsor:
Collaborators:
New York State Department of Health
Montefiore Medical Center
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine, Inc.

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: A= Yes Breakfast Other: B=No Breakfast Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Influence of Breakfast on Hormone Responses and Cognitive Performance, as Assessed by CTET in Lean and Obese Adolescent Males
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.




Primary Outcome Measures :
  1. The measurement of glucose will be euglycemic during the breakfast study visit [ 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 ]
    Area under the curve of glucose from time 0min to 420 min.

  2. The measurement of C-peptide will be steady during the breakfast study visit [ 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 ]
    Area under the curve of C-peptide from time 0min to 420 min.

  3. The measurement of insulin will be steady during the breakfast study visit [ 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 ]
    Area under the curve of insulin from time 0min to 420 min.

  4. The measurement of free fatty acids will be steady during the breakfast study visit [ 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 ]
    Area under the curve of free fatty acids from time 0min to 420 min.

  5. The measurement of glucagon-like peptide will be steady during the breakfast study visit [ 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 ]
    Area under the curve of glucagon- like peptide from time 0min to 420 min.

  6. The measurement of glucagon will be steady during the breakfast study visit [ 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 ]
    Area under the curve of glucagon from time 0min to 420 min.

  7. The measurement of CTET will be better during the breakfast study visit [ 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 ]
    Area under the curve of CTET from time 0min to 420 min.



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005951


Contacts
Contact: Jarreau Chen, M.D. 7189208193 jarchen@montefiore.org
Contact: Rubina Heptulla, MD 718-920-4664 rheptull@montefiore.org

Locations
United States, New York
Montefiore Medical Center of Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Contact: Rubina Heptulla, MD    718-920-4664    rheptull@montefiore.org   
Sub-Investigator: Sophie Molholm, Ph.D         
Principal Investigator: Rubina Heptulla, MD         
Sub-Investigator: John Foxe, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
New York State Department of Health
Montefiore Medical Center
Investigators
Principal Investigator: Rubina Heptulla, MD Albert Einstein College of Medicine. Montefiore Medical Center

Publications:
Responsible Party: Rubina Heptulla, Professor, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT03005951     History of Changes
Other Study ID Numbers: 2015-5542
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs