Thermic & Lipemic Properties of Dietary Carbohydrates

Dietary Modification Clinical Trial

— FL33  

Official title:

Thermic & Lipemic Properties of Dietary Carbohydrates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354574
• Other study ID #: 200210295
• Secondary ID: FL33
• Status: Completed
• Phase: N/A
• First received: August 13, 2010
• Last updated: July 12, 2011
• Start date: October 2002
• Est. completion date: June 2005

Study information

• Verified date: July 2011
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dietary Modification
• Exogenous Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Western Human Nutrition Research Center	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Burton-Freeman BM, Keim NL. Glycemic index, cholecystokinin, satiety and disinhibition: is there an unappreciated paradox for overweight women? Int J Obes (Lond). 2008 Nov;32(11):1647-54. doi: 10.1038/ijo.2008.159. Epub 2008 Sep 30. — View Citation

Motton DD, Keim NL, Tenorio FA, Horn WF, Rutledge JC. Postprandial monocyte activation in response to meals with high and low glycemic loads in overweight women. Am J Clin Nutr. 2007 Jan;85(1):60-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Gas Exchange	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.	No
Secondary	Plasma glucose	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.	No
Secondary	Circulating lipoproteins	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	No
Secondary	Subjective evaluation of appetite	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	No
Secondary	Food consumption at a buffet-style 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	No
Secondary	Body composition	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	No
Secondary	Serum insulin	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	No
Secondary	Plasma leptin	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	No
Secondary	Plasma ghrelin	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	No
Secondary	Cholecystokinin (CCK)	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	No
Secondary	GLP-1	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	No