Thermic & Lipemic Properties of Dietary Carbohydrates (FL33)

The purpose of this study is to determine if consumption of meals containing carbohydrates with different glycemic index (a high glycemic index meal and a low glycemic index meal)have different effects on energy expenditure, type of metabolic fuels used for energy, blood lipids and lipoproteins, and sensations of hunger, fullness, and the hormones related to satiety.

Study Overview

Detailed Description

Little is known about the metabolic effects of chronic dieting and weight cycling in humans, but limited evidence suggests that fatty acid oxidation may be depressed leading to periodic elevation of circulating lipids associated with meal ingestion and preferential storage of fat in adipose tissue. With the traditional approach of restrictive dieting failing to result in permanent weight loss and, possibly producing abnormalities in lipid metabolism, it is important to evaluate alternative approaches to achieve a healthy body weight through improved metabolism. In this study the investigators will test the postprandial metabolic effects of standard mixed meals containing carbohydrates with high glycemic index and compare these effects to responses obtained with standard mixed meals, matched for protein and fat content but containing carbohydrates with low glycemic index.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Davis, California, United States, 95616
        • Western Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Body mass index between 25 and 30 kg/m2
  • Having regular menses
  • Willing to refrain from restrictive dieting during the course of the study

Exclusion Criteria:

  • Pregnant or currently planning a pregnancy
  • Cigarette smoking
  • Taking medications to induce weight loss or change appetite
  • History of cardiovascular disease
  • History of metabolic disorders, including diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Glycemic Index meals
Three days of run-in diet with meals containing high glycemic index carbohydrates followed by test day with breakfast meal containing high glycemic index carbohydrates.
Dietary intervention with meals containing high glycemic index carbohydrates. All foods provided to meet the individual's energy needs. Standardized test meal (breakfast)also contained only high glycemic index carbohydrates and energy content was adjusted for each individual, providing 40% of daily energy needs.
Other Names:
  • Low Fiber Meals
Experimental: Low Glycemic Index meals
Three days of run-in diet with meals containing low glycemic index carbohydrates followed by test day with breakfast meal containing low glycemic index carbohydrates.
Dietary intervention with meals containing low glycemic index carbohydrates. All foods provided to meet the individual's energy needs. Standardized test meal (breakfast)also contained only low glycemic index carbohydrates and energy content was adjusted for each individual, providing 40% of daily energy needs.
Other Names:
  • High fiber meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Gas Exchange
Time Frame: 30 minutes before a standardized test meal and intermittently for 480 minutes following the meal.
Respiratory Gas Exchange will be measured using an automated metabolic cart. Gas analyzers and volumeter will be calibrated using manufacturer's procedures.
30 minutes before a standardized test meal and intermittently for 480 minutes following the meal.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma glucose
Time Frame: 10 blood samples taken over a 480 minute period.
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of standardized test meal.
10 blood samples taken over a 480 minute period.
Circulating lipoproteins
Time Frame: 4 blood samples taken over a 480 minute period
Blood samples for lipoprotein analyses were taken at fasting (0 minute) and at 150, 210, and 480 minutes following consumption of test meal. A subset of 10 randomly-selected subjects was chosen for this outcome measure
4 blood samples taken over a 480 minute period
Subjective evaluation of appetite
Time Frame: 16 timepoints measured over 600 minutes
Visual analog scales were used to assess appetite-related sensations. Four responses were obtained during the fasting phase (120 minutes) and 12 responses were obtained in the 480 minute postprandial period.
16 timepoints measured over 600 minutes
Food consumption at a buffet-style meal
Time Frame: at 480 minutes following test meal
The amount and types of foods consumed were measured after subject was presented with a buffet-style meal.
at 480 minutes following test meal
Body composition
Time Frame: measured the morning of the standard meal challenge
Body composition (fat mass, % fat, lean mass, bone density) will be measured using dual energy x-ray absorptiometry.
measured the morning of the standard meal challenge
Serum insulin
Time Frame: 10 blood samples taken over a 480 minute time period
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
10 blood samples taken over a 480 minute time period
Plasma leptin
Time Frame: 10 blood samples taken over a 480 minute period
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
10 blood samples taken over a 480 minute period
Plasma ghrelin
Time Frame: 10 blood samples taken over a 480 minute time period
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
10 blood samples taken over a 480 minute time period
Cholecystokinin (CCK)
Time Frame: 10 blood samples taken over a 480 minute time period
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
10 blood samples taken over a 480 minute time period
GLP-1
Time Frame: 10 blood samples taken over a 480 minute time period
1 fasting blood sample (0 minutes) and 9 post-prandial blood samples taken at 30, 60, 90, 120, 150, 210, 270, 360 and 480 minutes following consumption of test meal.
10 blood samples taken over a 480 minute time period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nancy L Keim, PhD, USDA, ARS, WHNRC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

August 13, 2010

First Submitted That Met QC Criteria

May 16, 2011

First Posted (Estimate)

May 17, 2011

Study Record Updates

Last Update Posted (Estimate)

July 13, 2011

Last Update Submitted That Met QC Criteria

July 12, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 200210295
  • FL33 (Other Identifier: USDA-ARS-WHNRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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