CancerCanDoNCT00561977
Cancer Dietary Objectives Study
A study testing High Fiber Diet, low saturated fat diet and Combination diet in people with Cancer and Heart Disease, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Heart Disease
- What is being tested?
- High Fiber Diet, low saturated fat diet and Combination diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥25, and ≤40.
- >=21 years of age, less than 81 years of age.
- has primary care physician's approval to participate in all aspects of the study,
- speaks, reads, and understands English at 6th grade level minimum
- residing in local area for the duration of the study.
- available for bi-monthly sessions (6 individual nutrition counseling visits)
Who cannot join
- presence of a psychological disorder that will limit his/her ability to participate (such as an eating disorder, uncontrolled bipolar disorder)
- unwilling to provide informed consent
- 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.
- currently taking any medication known to affect weight or appetite
- smokes more than 3 cigarettes a day on average
- Has a dietary restriction that precludes changing to the healthy diet, i.e.; Crohn's disease, ulcerative colitis, renal disease, active diverticulitis, etc.
Show all 10Show fewer
- currently following a specific diet plan (low saturated fat/meat, or high fiber)
- does not have a telephone
- 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)
- Has an active drug or alcohol problem within the past year -
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Finding a Simple Message to Improve Dietary Quality for Cancer and Heart Disease
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.
Read the detailed description
Summary of Grant:
Several studies have demonstrated that poor dietary quality is associated with obesity and certain cancers, such as gastrointestinal, colorectal, and hormonal cancers. Dietary interventions aimed at improving diet are plagued by poor adherence, possibly due to the complexity of changing multiple diet components. Complex public health messages are associated with worse adherence and reduced capacity to impact health outcomes. If a simple public health recommendation for diet was effective at changing multiple aspects of diet, adherence and impact could be maximized. However, research has yet to test which single dietary message has the greatest impact on overall diet quality, and consequently, potential for cancer and heart disease prevention. Thus far, dietary interventions have tested varying combinations of multiple recommendations; however, a single dietary recommendation may have a synergistic beneficial effect on other areas of diet, precluding the need to make the message overly complex.
The present study compares 3 dietary change conditions that are hypothesized to have high potential for synergistic effects on other unaddressed areas of diet, and consequently overall dietary quality. Patients were randomized to one of three arms:
- low saturated fat diet (≤7% of total calories);
- high fiber diet (≥30 grams of total fiber per day);
- combination arm: low saturated fat and high fiber.
Each participant was instructed to reduce calories by -500 kcal/day from his/her resting metabolic rate (RMR), but total calories was not less than 1200 calories per day.
Additionally, Dr. Ira Ockene, professor of medicine, director of preventive cardiology program, generously offered to pay for blood draws and blood lipids and glucose analysis at each visit to make the study valuable from both cancer and heart disease research perspectives.
Specific aims:
- Develop intervention materials. Intervention materials that specifically aid participants towards a low saturated fat or high fiber diet, or combination change developed for each condition.
- Preliminary test of intervention. We will calculate change in diet quality, lipids, body weight, waist circumference, and blood pressure at 3- and 6-months. We hypothesize that the single change conditions will produce more changes than the complex condition and that adding beneficial high fiber foods to the diet will result in improved dietary quality (measured by the Alternative Healthy Eating Index) than reducing saturated fat. Secondary outcomes include calorie intake, micro- and macronutrients at baseline, physical activity, and observe changes at 3- and 6-months.
- Adherence. We will examine adherence to the treatment protocol so that appropriate adjustments to the intervention can be made, if necessary, to enhance adherence in the larger randomized clinical trial.
- Data for sample size estimation. We will document means and standard deviations on measures so that sample size can be estimated for the larger randomized clinical trial.
- Conditions
- Cancer, Heart Disease
- Being tested
- High Fiber Diet, low saturated fat diet, Combination diet
- Keywords
- Nutrition, Dietary Quality, Weight loss
- Medical subject headings
- Neoplasms, Heart Diseases, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fiber DietBehavioural
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.
low saturated fat dietBehavioural
low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal/day.
Combination dietBehavioural
combination low saturated fat high fiber diet, with calorie restriction as specified.
| Study group | Role | What they receive |
|---|---|---|
| High Fiber Diet | Active comparator | 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. Receives: Behavioral: High Fiber Diet |
| Low Saturated Fat | Active comparator | low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day. Receives: Behavioral: low saturated fat diet |
| Combination Diet | Active comparator | Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day. Receives: Behavioral: Combination diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Quality
Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).
Measured: 6 mos
Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).
The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0-10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).
Measured: 3 months
Secondary outcomes (4)
Change in Weight From Baseline to 3 Months
Measured: 3 months
Change in Weight From Baseline to 6 Months
Measured: 6 months
Change in Calories From Baseline to 3 Months
kilocalories
Measured: 3 months
Change in Calories From Baseline to 6 Months
kilocalories
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Investigators
- Barbara C Olendzki, RD MPH, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561977
- Sponsor's protocol ID
- IRG 93-033
- Acronym
- CanDo
- Status last verified
- Aug 2011
- First submitted
- 20 Nov 2007
- Last updated
- 2 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Olendzki 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.
PubMed 19359142
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding a Simple Message to Improve Dietary Quality for Cancer and Heart Disease
- ClinicalTrials.gov ID
- NCT00561977
- Acronym / sponsor ID
- CanDo / IRG 93-033
- Conditions
- Cancer, Heart Disease
- Keywords
- Nutrition, Dietary Quality, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- May 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Posted 2 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Summary of Grant:
Several studies have demonstrated that poor dietary quality is associated with obesity and certain cancers, such as gastrointestinal, colorectal, and hormonal cancers. Dietary interventions aimed at improving diet are plagued by poor adherence, possibly due to the complexity of changing multiple diet components. Complex public health messages are associated with worse adherence and reduced capacity to impact health outcomes. If a simple public health recommendation for diet was effective at changing multiple aspects of diet, adherence and impact could be maximized. However, research has yet to test which single dietary message has the greatest impact on overall diet quality, and consequently, potential for cancer and heart disease prevention. Thus far, dietary interventions have tested varying combinations of multiple recommendations; however, a single dietary recommendation may have a synergistic beneficial effect on other areas of diet, precluding the need to make the message overly complex.
The present study compares 3 dietary change conditions that are hypothesized to have high potential for synergistic effects on other unaddressed areas of diet, and consequently overall dietary quality. Patients were randomized to one of three arms:
- low saturated fat diet (≤7% of total calories);
- high fiber diet (≥30 grams of total fiber per day);
- combination arm: low saturated fat and high fiber.
Each participant was instructed to reduce calories by -500 kcal/day from his/her resting metabolic rate (RMR), but total calories was not less than 1200 calories per day.
Additionally, Dr. Ira Ockene, professor of medicine, director of preventive cardiology program, generously offered to pay for blood draws and blood lipids and glucose analysis at each visit to make the study valuable from both cancer and heart disease research perspectives.
Specific aims:
- Develop intervention materials. Intervention materials that specifically aid participants towards a low saturated fat or high fiber diet, or combination change developed for each condition.
- Preliminary test of intervention. We will calculate change in diet quality, lipids, body weight, waist circumference, and blood pressure at 3- and 6-months. We hypothesize that the single change conditions will produce more changes than the complex condition and that adding beneficial high fiber foods to the diet will result in improved dietary quality (measured by the Alternative Healthy Eating Index) than reducing saturated fat. Secondary outcomes include calorie intake, micro- and macronutrients at baseline, physical activity, and observe changes at 3- and 6-months.
- Adherence. We will examine adherence to the treatment protocol so that appropriate adjustments to the intervention can be made, if necessary, to enhance adherence in the larger randomized clinical trial.
- Data for sample size estimation. We will document means and standard deviations on measures so that sample size can be estimated for the larger randomized clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Fiber Diet | Active comparator | Behavioral: High Fiber Diethigh 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. |
| Low Saturated Fat | Active comparator | Behavioral: low saturated fat dietlow saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day. |
| Combination Diet | Active comparator | Behavioral: Combination dietCombination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI ≥25, and ≤40.
- >=21 years of age, less than 81 years of age.
- has primary care physician's approval to participate in all aspects of the study,
- speaks, reads, and understands English at 6th grade level minimum
- residing in local area for the duration of the study.
Key exclusion criteria (10 listed)
- presence of a psychological disorder that will limit his/her ability to participate (such as an eating disorder, uncontrolled bipolar disorder)
- unwilling to provide informed consent
- 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.
- currently taking any medication known to affect weight or appetite
- smokes more than 3 cigarettes a day on average
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Fiber Diethigh 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. | Behavioural | High Fiber Diet |
| low saturated fat dietlow saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal/day. | Behavioural | Low Saturated Fat |
| Combination dietcombination low saturated fat high fiber diet, with calorie restriction as specified. | Behavioural | Combination Diet |
Primary outcome
Dietary Quality
Time frame: 6 mos
Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).
Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).
Time frame: 3 months
The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0-10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).
4 secondary outcomes
Change in Weight From Baseline to 3 Months
Time frame: 3 months
Change in Weight From Baseline to 6 Months
Time frame: 6 months
Change in Calories From Baseline to 3 Months
Time frame: 3 months
Change in Calories From Baseline to 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19359142Olendzki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara C Olendzki, RD MPH principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Fiber Diet, low saturated fat diet and Combination diet in people with Cancer and Heart Disease, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Quality (time frame: 6 mos). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00561977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2011.