Colorectal CancerNCT00932308
Colorectal Inflammatory Response to a Western-Style Diet
A study testing Western-style diet (WD) and Prudent Diet (PD) in people with Colorectal Cancer, run by Rockefeller University at 1 site in United States.
Trial summary
The investigators are involved in a research program to understand how different diets may affect the risk of colorectal polyps and cancer. To that end, the investigators are conducting a study of a western style diet versus a "prudent style" diet in which volunteer subjects are provided a different diet for 2… Read more about this study
- Who is it for?
- Ages 50 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Western-style diet (WD) and Prudent Diet (PD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and post-menopausal healthy female subjects, aged 50-72 years, who have had a colorectal adenoma removed, or have a first or second degree relative with colorectal neoplasia and thus are themselves at risk for colorectal cancer.
Who cannot join
- Personal history of cancer other than non-melanoma skin cancer within the past 10 years
- History of hereditary non-polyposis colon cancer
- Intestinal malabsorption, inflammatory bowel disease
- Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus
- Any excess bleeding or coagulation disorders
- Subjects taking anti-coagulants, sterol-binding resins, NSAIDs other than aspirin, < 600mg per day, other study medications, or other multiple medications that might, in the view of the study physicians, alter colonic function of inflammation
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- Sustained blood pressure > 150/95 mm Hg for three consecutive readings
- Total cholesterol greater than 240mg/dL, triglycerides >600mg, LDL-C > 175
- Subjects with a history of coronary artery disease, with EKG changes consistent with a past myocardial infarction
- HIV positive subjects
- Subjects taking antibiotics, anti-diabetes, hormone replacement therapy, oral, transplanted or injected contraceptives (thyroid hormone therapy is permitted as long as the subjects is euthyroid)
- Subjects consuming a vegetarian diet or a very "prudent diet"
- Withdrawal Criteria:
- If a subject is suspected of having taken illicit drugs, the subject will be asked to take a urine test. If positive, the subject will be withdrawn from the study
- The subject takes any medication prescribed without prior approval of the investigator
- Persistent noncompliance with the diets prescribed by the RUH nutritionists
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are involved in a research program to understand how different diets may affect the risk of colorectal polyps and cancer. To that end, the investigators are conducting a study of a western style diet versus a "prudent style" diet in which volunteer subjects are provided a different diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week inpatient periods they receive a Western style diet and during the other 4 week inpatient period they receive a "Prudent style" diet. The investigators will determine changes within the colon as a result of the two different diets. A more detailed description of the study is provided below.
Read the detailed description
Study subjects participate for about 3 months. During this time, there is one outpatient visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and finally another 4 week inpatient period. During the inpatient periods The Rockefeller University Hospital becomes your home the subject must sleep here every night and consume all the food provided. During the screening visit blood and urine samples will be taken and an EKC (electrocardiogram) and a complete physical exam will be done. After enrollment into the study, the first 4 week inpatient period begins. You may continue to go to work or do other activities as long as you eat the diet provided and sleep at the Rockefeller University Hospital. You must eat everything that we give you and you may not substitute or supplement the diet in any way. During each 4 week stay at The Rockefeller University Hospital, there will be three flexible sigmoidoscopies done and biopsies taken of the mucosal lining of the colorectum. This procedure is painless and takes about 5 minutes. In addition, blood and stool samples will be taken every few days for follow-up and research, two 24 hour urine samples will be done on separate days during the hospitalization. Vital signs are measured every day and your weight will be measured three times per week. During the four week wash out period, the subject will return to their home, go about their normal activities and consume their normal diet. The subject will return to The Rockefeller University Hospital for the second 4 week inpatient period. The procedures and laboratory tests are the same during the second inpatient period. The study concludes with the subjects discharge from the RUH.
- Conditions
- Colorectal Cancer
- Being tested
- Western-style diet (WD), Prudent Diet (PD)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western-style diet (WD)Dietary supplement
Will comprise of approximately 40% fat, 40% carbohydrates, 20% protein, and 350mg calcium, prepared by the Bionutrition Department using the USDA Nutrient Database.
Prudent Diet (PD)Dietary supplement
Will contain approximately 20% fat, 60% carbohydrate, 20% protein, and 1100mg calcium; the diets will consist of a 2-day rotating metabolic menu.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Western-style, high-fat, low-calcium diet (WD) Receives: Dietary Supplement: Western-style diet (WD) |
| 2 | Active comparator | Prudent, low-fat, calcium sufficient diet (PD) Receives: Dietary Supplement: Prudent Diet (PD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration.
Measured: Day 1 and Day 28
Secondary outcomes (5)
Expression Profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies as determined by microarray assay and RT-PCR.
Measured: Day 1 and Day 28
Selected pro- and anti-inflammatory proteins in rectal biopsies
Measured: Day 1 and Day 28
The levels of selected circulating and potential urinary inflammatory markers
Measured: Day 27
The concentration of fecal calprotectin
Measured: Day -1, 7,14,21 and 27
Changes in bulk fecal and epithelial associated microbiota that may determine changes in colorectal epithelial cell biologic pathways.
Measured: Days -1, 7,14,21 and 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startSep 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Holt, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932308
- Sponsor's protocol ID
- PHO-0588
- Status last verified
- Feb 2012
- First submitted
- 11 Dec 2008
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Inflammatory Response to a Western-Style Diet
- ClinicalTrials.gov ID
- NCT00932308
- Acronym / sponsor ID
- PHO-0588
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are involved in a research program to understand how different diets may affect the risk of colorectal polyps and cancer. To that end, the investigators are conducting a study of a western style diet versus a "prudent style" diet in which volunteer subjects are provided a different diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week inpatient periods they receive a Western style diet and during the other 4 week inpatient period they receive a "Prudent style" diet. The investigators will determine changes within the colon as a result of the two different diets. A more detailed description of the study is provided below.
Detailed description
Study subjects participate for about 3 months. During this time, there is one outpatient visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and finally another 4 week inpatient period. During the inpatient periods The Rockefeller University Hospital becomes your home the subject must sleep here every night and consume all the food provided. During the screening visit blood and urine samples will be taken and an EKC (electrocardiogram) and a complete physical exam will be done. After enrollment into the study, the first 4 week inpatient period begins. You may continue to go to work or do other activities as long as you eat the diet provided and sleep at the Rockefeller University Hospital. You must eat everything that we give you and you may not substitute or supplement the diet in any way. During each 4 week stay at The Rockefeller University Hospital, there will be three flexible sigmoidoscopies done and biopsies taken of the mucosal lining of the colorectum. This procedure is painless and takes about 5 minutes. In addition, blood and stool samples will be taken every few days for follow-up and research, two 24 hour urine samples will be done on separate days during the hospitalization. Vital signs are measured every day and your weight will be measured three times per week. During the four week wash out period, the subject will return to their home, go about their normal activities and consume their normal diet. The subject will return to The Rockefeller University Hospital for the second 4 week inpatient period. The procedures and laboratory tests are the same during the second inpatient period. The study concludes with the subjects discharge from the RUH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Western-style diet (WD)Western-style, high-fat, low-calcium diet (WD) |
| 2 | Active comparator | Dietary Supplement: Prudent Diet (PD)Prudent, low-fat, calcium sufficient diet (PD) |
Who may qualify
- Ages
- 50 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and post-menopausal healthy female subjects, aged 50-72 years, who have had a colorectal adenoma removed, or have a first or second degree relative with colorectal neoplasia and thus are themselves at risk for colorectal cancer.
Key exclusion criteria (16 listed)
- Personal history of cancer other than non-melanoma skin cancer within the past 10 years
- History of hereditary non-polyposis colon cancer
- Intestinal malabsorption, inflammatory bowel disease
- Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus
- Any excess bleeding or coagulation disorders
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 |
|---|---|---|
| Western-style diet (WD)Will comprise of approximately 40% fat, 40% carbohydrates, 20% protein, and 350mg calcium, prepared by the Bionutrition Department using the USDA Nutrient Database. | Dietary supplement | 1 |
| Prudent Diet (PD)Will contain approximately 20% fat, 60% carbohydrate, 20% protein, and 1100mg calcium; the diets will consist of a 2-day rotating metabolic menu. | Dietary supplement | 2 |
Primary outcome
The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration.
Time frame: Day 1 and Day 28
5 secondary outcomes
Expression Profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies as determined by microarray assay and RT-PCR.
Time frame: Day 1 and Day 28
Selected pro- and anti-inflammatory proteins in rectal biopsies
Time frame: Day 1 and Day 28
The levels of selected circulating and potential urinary inflammatory markers
Time frame: Day 27
The concentration of fecal calprotectin
Time frame: Day -1, 7,14,21 and 27
Changes in bulk fecal and epithelial associated microbiota that may determine changes in colorectal epithelial cell biologic pathways.
Time frame: Days -1, 7,14,21 and 27
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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.
Peter Holt, MD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Western-style diet (WD) and Prudent Diet (PD) in people with Colorectal Cancer, run by Rockefeller University 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 1 inclusion and 16 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 17 Feb 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration. (time frame: Day 1 and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2012.