Clinical trial · Interventional
Cancer Dietary Objectives Study
Finding a Simple Message to Improve Dietary Quality for Cancer and Heart Disease
NCT00561977CI-TRIAL-00005439CanDocompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We hypothesize that adding beneficial high fiber foods to the diet will result in better overall dietary quality (measured by the Alternate Healthy Eating Index), which has been shown to be associated with cancer, than either reducing saturated fat, or a combination of high fiber and low saturated fat.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Heart Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination diet | Behavioral | — | UNRESOLVED |
| High Fiber Diet | Behavioral | — | UNRESOLVED |
| low saturated fat diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- High Fiber Diet
- description
- high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
- interventionNames
- Behavioral: High Fiber Diet
- type
- ACTIVE_COMPARATOR
- label
- Low Saturated Fat
- description
- low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
- interventionNames
- Behavioral: low saturated fat diet
- type
- ACTIVE_COMPARATOR
- label
- Combination Diet
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. BMI ≥25, and ≤40. 2. \>=21 years of age, less than 81 years of age. 3. has primary care physician's approval to participate in all aspects of the study, 4. speaks, reads, and understands English at 6th grade level minimum 5. residing in local area for the duration of the study. 6. available for bi-monthly sessions (6 individual nutrition counseling visits) Exclusion Criteria: 1. presence of a psychological disorder that will limit his/her ability to participate (such as an eating disorder, uncontrolled bipolar disorder) 2. unwilling to provide informed consent 3. presence of unstable medical disorder (e.g., uncontrolled hypertension, uncontrolled diabetes, etc), or a medical disorder associated with a life expectancy less than 2 years. 4. currently taking any medication known to affect weight or appetite 5. smokes more than 3 cigarettes a day on average 6. Has a dietary restriction that precludes changing to the healthy diet, i.e.; Crohn's disease, ulcerative colitis, renal disease, active diverticulitis, etc. 7. currently following a specific diet plan (low saturated fat/meat, or high fiber) 8. does not have a telephone 9. Pregnant, or planning to become pregnant (participant will be asked this question in telephone screening. If the participant becomes pregnant, they are asked to inform the principal investigator) 10. Has an active drug or alcohol problem within the past year -
References
Publications (1)
- RESULTOlendzki BC, Ma Y, Schneider KL, Merriam P, Culver AL, Ockene IS, Pagoto S. A simple dietary message to improve dietary quality: Results from a pilot investigation. Nutrition. 2009 Jul-Aug;25(7-8):736-44. doi: 10.1016/j.nut.2009.01.009. Epub 2009 Apr 9. PMID 19359142