Thermic & Lipemic Properties of Dietary Carbohydrates (FL33)

This study has been completed.
Sponsor:
Information provided by:
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01354574
First received: August 13, 2010
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Exogenous Obesity
Dietary Modification
Other: High Glycemic Index meals
Other: Low Glycemic Index meals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Thermic & Lipemic Properties of Dietary Carbohydrates

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Respiratory Gas Exchange [ Time Frame: 30 minutes before a standardized test meal and intermittently for 480 minutes following the meal. ] [ Designated as safety issue: No ]
    Respiratory Gas Exchange will be measured using an automated metabolic cart. Gas analyzers and volumeter will be calibrated using manufacturer's procedures.


Secondary Outcome Measures:
  • Plasma glucose [ Time Frame: 10 blood samples taken over a 480 minute period. ] [ Designated as safety issue: No ]
    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.

  • Circulating lipoproteins [ Time Frame: 4 blood samples taken over a 480 minute period ] [ Designated as safety issue: No ]
    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

  • Subjective evaluation of appetite [ Time Frame: 16 timepoints measured over 600 minutes ] [ Designated as safety issue: No ]
    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.

  • Food consumption at a buffet-style meal [ Time Frame: at 480 minutes following test meal ] [ Designated as safety issue: No ]
    The amount and types of foods consumed were measured after subject was presented with a buffet-style meal.

  • Body composition [ Time Frame: measured the morning of the standard meal challenge ] [ Designated as safety issue: No ]
    Body composition (fat mass, % fat, lean mass, bone density) will be measured using dual energy x-ray absorptiometry.

  • Serum insulin [ Time Frame: 10 blood samples taken over a 480 minute time period ] [ Designated as safety issue: No ]
    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.

  • Plasma leptin [ Time Frame: 10 blood samples taken over a 480 minute period ] [ Designated as safety issue: No ]
    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.

  • Plasma ghrelin [ Time Frame: 10 blood samples taken over a 480 minute time period ] [ Designated as safety issue: No ]
    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.

  • Cholecystokinin (CCK) [ Time Frame: 10 blood samples taken over a 480 minute time period ] [ Designated as safety issue: No ]
    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.

  • GLP-1 [ Time Frame: 10 blood samples taken over a 480 minute time period ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: October 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: High Glycemic Index meals
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 Name: 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.
Other: Low Glycemic Index meals
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 Name: High fiber meals

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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354574

Locations
United States, California
Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Nancy L Keim, PhD USDA, ARS, WHNRC
  More Information

Publications:
Responsible Party: Nancy L. Keim, USDA, ARS, WHNRC
ClinicalTrials.gov Identifier: NCT01354574     History of Changes
Other Study ID Numbers: 200210295, FL33
Study First Received: August 13, 2010
Last Updated: July 12, 2011
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
energy metabolism
lipids
lipoproteins
satiety
glycemic load
insulin

Additional relevant MeSH terms:
Obesity
Food Habits
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Habits

ClinicalTrials.gov processed this record on July 20, 2014