The Breakfast Study

Status Completed

Clinical Trial Summary

The overall objective is to investigate the effects of low and high glycemic index (GI) meals varying in protein content on plasma glucose and insulin response, subjective ratings of hunger, and subsequent food intake in twenty healthy, sedentary, overweight and obese men and women between the ages of 21-65.

Clinical Trial Description

Each individual will participate separately in four testing sessions. Each testing session will last for approximately 5 hours and will be separated by a minimum of one week. Participants will arrive at the Temple University GCRC or CORE at either 7:30 a.m. or 8:30 a.m. after an overnight fast (10-12 hours) to ensure that all participants are in the same metabolic state. Upon arrival the experimenter will ask participants to complete a pre-session questionnaire and rate their feelings of hunger and satiety on a visual analog scale (VAS). An indwelling catheter will be inserted in an antecubital vein by the study nurse and a baseline blood sample will be obtained for measurement of glucose and insulin concentrations. Glucose will be measured by the glucose oxidase method using a glucose analyzer and insulin will be measured by radioimmunoassay.

One of four isocaloric meals (see example below), varying in macronutrient content and GI value of foods, will be administered in random order at either 8:00 a.m. or 9:00 a.m. Energy density will be controlled. The meal and 8 ounces of water will be consumed within fifteen minutes. A short visual analog questionnaire will be distributed at the conclusion of the meal to rate the meal consumed. Blood samples will be taken 15 minutes after food consumption and at 30 minute intervals (i.e., 30, 60, 90, 120, 150, 180, 210, and 240 minutes) over four hours following administration of the meal. Four milliliters of blood will be collected at each time point (via indwelling catheter), resulting in a total of 40 milliliters of blood collected at each study session and 160 milliliters (i.e., 40 ml x 4 testing sessions) within an 8 week time period. Participants will be asked to rate their feelings of hunger at these time points. Following the last blood sample, participants will be given the opportunity to consume food ad libitum from a buffet style lunch. Based on known serving sizes and measurements of unconsumed food, the amount of food eaten and its associated energy content will be determined. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00593307
Study type	Interventional
Source	Temple University
Contact
Status	Completed
Phase	N/A
Start date	January 2006
Completion date	June 2008

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06061419` - The Effect of Huel Powder on Appetite	N/A
Completed	`NCT03850990` - Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss	N/A
Completed	`NCT02827318` - Eating Disinhibition and Vagal Tone and the Postprandial Response to Glycaemic Load	N/A
Recruiting	`NCT03978975` - Water Exercise and Health (WATHEALTH)	N/A
Active, not recruiting	`NCT06082778` - ZOE's Ferment Experiment	N/A
Completed	`NCT05734209` - How Does Eating Behavior and Hunger in Virtual Reality Meals Compare to Real Meals?	N/A
Completed	`NCT02948816` - The Effects of Social Media on Food Intake and Behaviour	N/A
Completed	`NCT03900130` - The Omnibus Satiety Metric: Predicting Satiety in Humans Through Brain, Blood, and Subjective Data	N/A
Recruiting	`NCT05196763` - Maximizing Nutrition Education to Meet Dietary and Food Security of Children and Parents	N/A
Completed	`NCT03489226` - Capsimax Effect on Metabolic Rate, Satiety and Food Intake	N/A
Completed	`NCT03656146` - Food for Thought: Food Insecurity Screening in the Emergency Department	N/A
Recruiting	`NCT06340087` - Impact Hesperetin in Combination With Sucrose on Blood Glucose Regulation	Early Phase 1
Completed	`NCT01809925` - Study of Psyllium 6.8 g Versus Placebo on Satiety in Healthy Volunteers	N/A
Completed	`NCT01562678` - Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI	Phase 4
Completed	`NCT04884373` - Patient Satiety as an Indicator of Stomach Contents and Fluid Volume
Completed	`NCT02505490` - The Effect of Television Watching on Liking of Food	N/A
Completed	`NCT02577705` - Building Wealth and Health Network: A Microfinance/TANF Demonstration Project	N/A
Recruiting	`NCT03537781` - The Effect of Food Labelling and Satiety on Individuals Food Choice	N/A
Completed	`NCT02477410` - Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite	N/A
Completed	`NCT01924130` - School Breakfast Policy Initiative Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Breakfast Study — Breakfast

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms