The Breakfast Study

NCT ID: NCT00593307

Last Updated: 2013-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-06-30

Brief 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.

Detailed 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.

Conditions

Glycemic Response; Hunger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low GI

low GI breakfast

Group Type: EXPERIMENTAL

Low GI

Intervention Type: OTHER

low GI, high carb breakfast

Low GI -low carb

Low GI and Low carb breakfast

Group Type: EXPERIMENTAL

Low GI Low Carb

Intervention Type: OTHER

low GI low carb breakfast

High GI

High GI breakfast

Group Type: EXPERIMENTAL

high GI

Intervention Type: OTHER

high GI and high carb breakfast

High GI Low Carb

high GI low carb breakfast

Group Type: EXPERIMENTAL

High GI Low carb

Intervention Type: OTHER

high GI low carb breakfast

Interventions

high GI

high GI and high carb breakfast

Intervention Type: OTHER

Low GI

low GI, high carb breakfast

Intervention Type: OTHER

Low GI Low Carb

low GI low carb breakfast

Intervention Type: OTHER

High GI Low carb

high GI low carb breakfast

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women between the ages of 21-65 with a BMI of 25-40(kg/m2)

Exclusion Criteria

• Individuals who are currently dieting or restricting food intake and who report pre-existing health afflictions such as diabetes, use of prescription medications, use of appetite suppressants, or regular tobacco use will be excluded from the study as they may affect appetite or impact the dependent measures of this study.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Life Sciences Institute

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary D Foster, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University - Center for Obesity Research and Education

Locations

Temple University - Center for Obesity Research and Education

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

ILSI

Identifier Type: -

Identifier Source: secondary_id

10917

Identifier Type: -

Identifier Source: org_study_id