Carbohydrates and Related Biomarkers (CARB)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00622661
First received: February 14, 2008
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Healthy
Overweight
Other: Low Glycemic Load Diet
Other: High Glycemic Load Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Feeding Study to Examine the Effect of Glycemic Load and Obesity on Cancer Biomarkers

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk. [ Time Frame: two 4-week feeding periods (56 days total) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaires will generate data on how these diets may influence mood or depression, sleep habits, and measures of appetite and satiety. [ Time Frame: two 4-week feeding periods (56 days) ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: June 2006
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Normal weight
Other: Low Glycemic Load Diet
consume both high and low glycemic load diets for 28 days each
Other: High Glycemic Load Diet
consume both high and low glycemic load diets for 28 days each
2
Overweight
Other: Low Glycemic Load Diet
consume both high and low glycemic load diets for 28 days each
Other: High Glycemic Load Diet
consume both high and low glycemic load diets for 28 days each

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 tobacco).
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622661

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Marian Neuhouser, RD, PhD Fred Hutchinson Cancer Research Center
  More Information

No publications provided by Fred Hutchinson Cancer Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marian Neuhouser, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00622661     History of Changes
Other Study ID Numbers: PHS 2059.00, NIH/NCI U54 CA 116847, IR 6105
Study First Received: February 14, 2008
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
Glycemic response
Glycemic index
Obesity
Carbohydrates
Insulin
Blood glucose

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014