A Feeding Study to Examine the Effect of Glycemic Load and Obesity on Cancer Biomarkers
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.
Interventional
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.
two 4-week feeding periods (56 days total)
No
Marian Neuhouser, RD, PhD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Institutional Review Board
PHS 2059.00
NCT00622661
June 2006
July 2010
Name | Location |
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Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |