The Influence of Breakfast on Hormone Responses and Cognitive Performance

NCT03005951 | Completed DMC

• 1 other identifier: 2015-5542
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Lean males

EXPERIMENTAL

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; Other: B=No Breakfast

Obese males

EXPERIMENTAL

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; Other: B=No Breakfast

Interventions

A= Yes Breakfast 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

Lean males; Obese males

B=No Breakfast 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.

Lean males; Obese males

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• New York State Department of Health: collaborator
• Montefiore Medical Center: collaborator

Study Sites (1)

Montefiore Medical Center of Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 26220945 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lisa Underland, MD

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: December 30, 2016
• Study Start: August 30, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)