NCT01354574

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2010

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
Last Updated

July 13, 2011

Status Verified

July 1, 2011

Enrollment Period

2.7 years

First QC Date

August 13, 2010

Last Update Submit

July 12, 2011

Conditions

Exogenous ObesityDietary Modification

Keywords

energy metabolismlipidslipoproteinssatietyglycemic loadinsulin

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (10)

  • Plasma glucose

    10 blood samples taken over a 480 minute period.

  • Circulating lipoproteins

    4 blood samples taken over a 480 minute period

  • Subjective evaluation of appetite

    16 timepoints measured over 600 minutes

  • Food consumption at a buffet-style meal

    at 480 minutes following test meal

  • Body composition

    measured the morning of the standard meal challenge

  • +5 more secondary outcomes

Study Arms (2)

High Glycemic Index meals

EXPERIMENTAL

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

Low Glycemic Index meals

EXPERIMENTAL

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

Interventions

High Glycemic Index mealsOTHER

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.

Also known as: Low Fiber Meals
High Glycemic Index meals
Low Glycemic Index mealsOTHER

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.

Also known as: High fiber meals
Low Glycemic Index meals

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (2)

  • 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. doi: 10.1093/ajcn/85.1.60.

    PMID: 17209178RESULT

  • 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.

    PMID: 18825157RESULT

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nancy L Keim, PhD

    USDA, ARS, WHNRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

August 13, 2010

First Posted

May 17, 2011

Study Start

October 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

July 13, 2011

Record last verified: 2011-07

Locations

US(1)