Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 11:49 PM
Ignite Modification Date: 2025-12-24 @ 11:49 PM
NCT ID: NCT03005951
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.
Study: NCT03005951
Study Brief:
Protocol Section: NCT03005951