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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01031 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This randomized phase II trial will enroll overweight cancer survivors. Subjects in both groups will be educated to follow a diet pattern similar to what is recommended by the Dietary Guidelines for Americans and the American Institute for Cancer Research (DGA/AICR) but one group will also receive 18 ounces of lean beef for incorporation into a healthy diet. Subjects will be encouraged to exercise regularly and activity will be monitored throughout the study. Nutrition and exercise may help cancer survivors successfully maintain improved dietary patterns, body composition, and physical activity efforts and consumption of beef may favorably impact lean body mass and specific nutritional outcomes.
PRIMARY OBJECTIVES:
I. To determine the feasibility and compliance with a the Dietary Guidelines for Americans/American Institute for Cancer Research (DGA/AICR) healthy dietary pattern and a beef + DGA/AICR healthy dietary pattern in cancer survivors.
II. To determine the impact of dietary interventions on body composition, clinical outcomes, and physical performance.
III. To quantify the impact of the two dietary interventions on cardiometabolic biomarkers of health.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions over 60 minutes every other week, fruit, vegetable, and herb harvesting 1-2 times per week for 2 hours, wearing a FitBit during physical activity, and remote health coaching over 10 minutes for 12 weeks.
ARM II: Patients receive DGA/AICR-based dietary intervention as in Arm I and consume 11-18 ounces of lean beef each week for 6 months.
Clinical and physical activity assessments will take place at baseline, after the intervention and at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (DGA/AICR) | Active Comparator | Patients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions (60 minutes each) every other week. Lectures will take place in an urban garden where fruit, vegetable, and herb harvesting 1-2 times per week is encouraged. All participants will be given a FitBit and regular physical activity will be encouraged. Finally, remote health coaching is offered to all study subjects for the duration of the intervention (12 weeks). |
|
| Arm II (DGA/AICR plus Beef) | Experimental | Patients receive the same intervention as in Arm I with the addition of 18 ounces of lean beef provided by the study to each subject. Subjects will be encouraged to consume the lean beef and lectures will incorporate healthy beef consumption into each lesson and cooking demonstration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Other | Participants randomized to the DGA/AICR group will receive plant-based diet education, garden access and health coaching for 5 months. The sessions are offered every other week. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to either the DGA/AICR group or the DGA/AICR + Beef group | Participants will keep both 7 day diet records periodically through out the study as well as a daily log of beef consumption | Up to 12 months |
| Change in body composition | Change in body composition will be assessed by dual X-ray absorptiometry (iDXA) | Up to 12 months |
| Change in blood pressure | Trained personnel will use a sphygomanometer to assess blood pressure | Baseline up to 12 months |
| Change in body mass index (BMI) | Weight and height will be combined to report BMI in kg/m^2. | Baseline up to 12 months |
| Change in dietary carotenoid intake | Assessed by Raman spectroscopy | Baseline up to 12 months |
| Change in blood carotenoids | Assessed by High Pressure Liquid Chromatography | Up to 12 months |
| Change in physical performance assessed by timed performance-related mobility tasks | Physical performance will be measured using the 40 M walk test | Baseline up to 12 months |
| Change in physical performance |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | Measured at all three time points using the Health Related Quality of Life (HR-QOL) questionnaire | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Clinton, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41080470 | Derived | Hill EB, Pashkova A, Grainger EM, Roberts KM, Chitchumroonchokchai C, Braun AC, Ralston RA, Riedl KM, Spees CK, Clinton SK. Targeted Urinary Profiling as a Biomarker of Dietary Flavonoid Intake from Fruits and Vegetables and its Relationship to the Timing of Dietary Assessment. Curr Dev Nutr. 2025 Jul 31;9(9):107520. doi: 10.1016/j.cdnut.2025.107520. eCollection 2025 Sep. | |
| 39708224 |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| Exercise Intervention | Behavioral | Participants will wear a FitBit every day and monitor daily physical activity. |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Nutritional Intervention | Dietary Supplement | Participants randomized to the beef group will receive 11 to 18 ounces of frozen lean beef each week for home preparation, in addition to DGA/AICR diet education, garden access and health coaching. |
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| Questionnaire Administration | Other | Ancillary studies |
|
Assessed by a standardized stair climb test
| Up to 12 months |
| Dietary intake patterns | Will be assessed using diet logs maintained throughout the intervention and graphical food frequency questionnaire (FFQ). This FFQ automatically calculates the Healthy Eating Index 2010. Will use previous 30-day intake for all FFQs to assess dietary patterns. To determine protein balance, will use a 7-day diet record prior to a 24-hr urine collection. | Up to 6 months |
| Adherence to classes | Descriptive statistics will be generated using attendance forms | Up to 12 months |
| Change in fasting glucose | A fasting blood sample will be used to measure glucose at three time points | Up to 12 months |
| Change in lipoprotein profiles | A fasting blood sample will be used to assess serum lipoprotein profile | Up to 12 months |
| Daily physical activity (steps per day) | Each participants daily FitBit data will be downloaded to a secure spreadsheet | up to 12 months |
| Derived |
| Braun AC, Portner J, Grainger EM, Clinton SK, Xu M, Darragh A, Pratt KJ, Weaver LL, Spees CK. Impact of Dietitian-Delivered Motivational Interviewing Within a Food is Medicine Intervention Targeting Adults Living With and Beyond Cancer. J Cancer Educ. 2025 Aug;40(4):609-615. doi: 10.1007/s13187-024-02552-4. Epub 2024 Dec 21. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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