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Completed

NCT Number: NCT01354574

Thermic & Lipemic Properties of Dietary Carbohydrates

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.

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Key information

Conditions

Exogenous Obesity Dietary Modification Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Glycemic Index meals

Other

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

Low Glycemic Index meals

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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. 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.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Acronym: FL33

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
May 17, 2011
Registry last updated
Jul 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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