Carbohydrates and Related Biomarkers (CARB)

January 4, 2012 updated by: Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
two 4-week feeding periods (56 days total)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
two 4-week feeding periods (56 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Marian Neuhouser, RD, PhD, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (ESTIMATE)

February 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHS 2059.00
  • NIH/NCI U54 CA 116847
  • IR 6105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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