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

18 Years
45 Years
Not Enrolling
Healthy, Overweight

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Trial Information

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.

Inclusion Criteria:

1. Healthy males and female subjects

2. Between the ages of 18 to 45

3. BMI between 18.5 kg/m2 to 24. 9 kg/m2 (normal weight) and between 28.0 kg/m2 to 39.9
kg/m2 (overweight)

4. Willingness to refrain from alcohol during the study

5. Able to come to the FHCRC in Seattle every weekday night for dinner

Exclusion Criteria:

1. Younger than 18 years of age or older than 45 years of age.

2. Do not fit into one of the study weight groups (normal weight and overweight): BMI <
18.5 kg/m2 or > 40.0 kg/m2, and between 25.0 kg/m2and 27.9 kg/m2

3. Have diseases that are treated by diet and/or medications including but not limited
to diabetes, kidney disease, heart disease

4. Taking prescription medications every day (this includes women taking birth-control
pills, shots, patch or IUD with hormones)

5. Diagnosed with or treated for cancer within the previous five years (except those
with a diagnosis and/or treatment of non-melanomatous skin cancer are eligible)

6. Currently pregnant or breastfeeding or planning a pregnancy in the next 3 months.

7. Using any tobacco products on a daily basis (cigarettes, pipes, cigars, chewing

8. Using recreational drugs

9. Drinking the following amount of alcohol almost every day: 2 or more cans/bottles of
beer OR 2 or more glasses of wine OR 3 or more ounces of hard liquor.

10. Inability (e.g., food allergy or intolerances) or unwillingness to consume the foods
that are part of the feeding study diet.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.

Outcome Time Frame:

two 4-week feeding periods (56 days total)

Safety Issue:


Principal Investigator

Marian Neuhouser, RD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Institutional Review Board

Study ID:

PHS 2059.00



Start Date:

June 2006

Completion Date:

July 2010

Related Keywords:

  • Healthy
  • Overweight
  • Glycemic response
  • Glycemic index
  • Obesity
  • Carbohydrates
  • Insulin
  • Blood glucose
  • Overweight



Fred Hutchinson Cancer Research CenterSeattle, Washington  98109