Clinical Trials Directory

Trials / Completed

CompletedNCT00622661

Carbohydrates and Related Biomarkers

A Feeding Study to Examine the Effect of Glycemic Load and Obesity on Cancer Biomarkers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
89 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.

Detailed description

This is a randomized, crossover feeding study conducted in normal weight and overweight individuals. Participants will be given all their food to eat and drink (except water) for two 28-day feeding periods (a total of 56 days). The diets will be carefully controlled and energy intake will be regulated to maintain weight stability for each participant. The two feeding periods will be separated by a 28 day "washout" period when participants will eat their own food. Dinner will be eaten at the Hutchinson Center Monday through Friday. Each evening, breakfast, lunch and snacks will be brought home for the next day. On Friday evenings all the food will be taken home for the weekend. Samples of blood will be collected after an overnight fast at the beginning and the end of each feeding period. All urine will be collected for 24 hours at the end of each feeding period. A number of questionnaires will also be completed during each diet period. A small stool sample will be collected in your own home, before the first feeding period, and once during each feeding period. The stool sample collection is optional. One can decide not to provide a stool sample and still participate in the study.

Conditions

Interventions

TypeNameDescription
OTHERLow Glycemic Load Dietconsume both high and low glycemic load diets for 28 days each
OTHERHigh Glycemic Load Dietconsume both high and low glycemic load diets for 28 days each

Timeline

Start date
2006-06-01
Primary completion
2009-07-01
Completion
2010-07-01
First posted
2008-02-25
Last updated
2012-01-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00622661. Inclusion in this directory is not an endorsement.