Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
NCT ID: NCT02129218
Last Updated: 2018-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2015-02-16
2018-07-10
Brief Summary
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Detailed Description
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I. To determine the feasibility of following a low or medium glycemic load diet in patients with stage I-III (local-regional) colon cancer.
SECONDARY OBJECTIVES:
I. To determine patient-reported acceptability of diet. II. To determine nutritionist resources utilized. III. To evaluate the effect of lowering dietary glycemic load on body mass index (BMI), lipid metabolism and pro-oncogenic intermediaries of cellular metabolism.
OUTLINE: Patients are sequentially enrolled in 1 of 4 possible cohorts as needed based on the feasibility of the prior cohort.
COHORT 1: Patients follow a low glycemic load diet with standard dietary intervention (contact with nutritionist in person every 2 weeks with phone contact on the alternating weeks) for 12 weeks.
COHORT 2: Patients follow a low glycemic load diet with intensified dietary intervention (contact with nutritionist in person every week) for 12 weeks.
COHORT 3: Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
COHORT 4: Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Cohort 1: Low glycemic load with standard diet
Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
questionnaire administration
Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
Standard Dietary Intervention
Participants will be contacted by a nutritionist, in person every 2 weeks with phone contact on the alternating weeks. At the initial visit, each participant will be given verbal and written patient education materials, including low glycemic load diet recipes, meal plans, food preparation, and grocery shopping information. Individual instruction will be tailored to their baseline dietary preferences (e.g. vegan, allergies, etc).
Low glycemic load
Cohort 2: Low glycemic load with intensified diet
Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
questionnaire administration
Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
laboratory biomarker analysis
Correlative studies
Intensified Dietary Intervention
Patients will be contacted weekly, in person, by a nutritionist . Participants will take part in a cooking demonstration at the time of their initial visit. The demonstration will be hands-on and participants will be able to sample foods and recipes. In addition to grocery shopping information, participants will be accompanied by a nutritionist to their local grocery store to practice new shopping habits for their target dietary glycemic load. Each participant will also receive weekly random phone calls to assess his or her progress.
Low glycemic load
Cohort 3: Medium glycemic load with standard diet
Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
questionnaire administration
Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
laboratory biomarker analysis
Correlative studies
Standard Dietary Intervention
Participants will be contacted by a nutritionist, in person every 2 weeks with phone contact on the alternating weeks. At the initial visit, each participant will be given verbal and written patient education materials, including low glycemic load diet recipes, meal plans, food preparation, and grocery shopping information. Individual instruction will be tailored to their baseline dietary preferences (e.g. vegan, allergies, etc).
Medium Glycemic Load
Cohort 4: Medium glycemic load with intensified diet
Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
questionnaire administration
Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
laboratory biomarker analysis
Correlative studies
Intensified Dietary Intervention
Patients will be contacted weekly, in person, by a nutritionist . Participants will take part in a cooking demonstration at the time of their initial visit. The demonstration will be hands-on and participants will be able to sample foods and recipes. In addition to grocery shopping information, participants will be accompanied by a nutritionist to their local grocery store to practice new shopping habits for their target dietary glycemic load. Each participant will also receive weekly random phone calls to assess his or her progress.
Medium Glycemic Load
Interventions
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questionnaire administration
Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
laboratory biomarker analysis
Correlative studies
Standard Dietary Intervention
Participants will be contacted by a nutritionist, in person every 2 weeks with phone contact on the alternating weeks. At the initial visit, each participant will be given verbal and written patient education materials, including low glycemic load diet recipes, meal plans, food preparation, and grocery shopping information. Individual instruction will be tailored to their baseline dietary preferences (e.g. vegan, allergies, etc).
Intensified Dietary Intervention
Patients will be contacted weekly, in person, by a nutritionist . Participants will take part in a cooking demonstration at the time of their initial visit. The demonstration will be hands-on and participants will be able to sample foods and recipes. In addition to grocery shopping information, participants will be accompanied by a nutritionist to their local grocery store to practice new shopping habits for their target dietary glycemic load. Each participant will also receive weekly random phone calls to assess his or her progress.
Low glycemic load
Medium Glycemic Load
Eligibility Criteria
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Inclusion Criteria
* Patients must regularly consume a diet with a glycemic load \> 150 as estimated through the 3 day food recall
* Patients must readily be available for a 3 month period and agree to participate in regular dietary adherence assessments (surveys and phone interviews)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michelle Treasure, MD
Role: STUDY_DIRECTOR
Case Comprehensive Cancer Center
Locations
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Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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NCI-2014-00831
Identifier Type: REGISTRY
Identifier Source: secondary_id
CASE7213
Identifier Type: OTHER
Identifier Source: secondary_id
CASE7213
Identifier Type: -
Identifier Source: org_study_id
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