Breast CancerNCT01824498
Dietary Fat, Eicosanoids and Breast Cancer Risk
A study testing Low Fat diet, Low Fat high n3 diet and High Fat Diet in people with Breast Cancer, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Low Fat diet, Low Fat high n3 diet and High Fat Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Nov 2010
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- 45 to 70 years old,
- at least one year since their last menstrual period
- not using hormone replacement therapy,
- BMI between 19 -29
- willingness to discontinue use of over-the-counter medications with anti-prostaglandin activity such as aspirin or non-steroidal anti-inflammatory medications
- consumption of a "Typical " American diet with no unusual dietary practices such as compliance with a strict vegetarian diet
- willingness to comply with the demands of the experimental protocol.
Who cannot join
- Smoking
- Known disease process, and 3) Use of prescription medications, including hormone replacement therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer
Read the detailed description
The guiding concept of our proposal is that both the total fat and the fatty acid composition of the diet contribute to a milieu associated with the risk for sex-hormone mediated cancers. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer. When compared with the high fat diet, we expect n3 concentrations to increase and sex hormone levels to decrease after both low fat and low fat/n3 rich diets, with the greatest response in the low fat-n3 supplemented group. The aims of this project are: 1) to evaluate the effects of total fat and n3 fatty acid consumption on plasma and urine sex hormone concentrations in postmenopausal women, 2) to evaluate the relationship between plasma concentrations of fatty acids and plasma and urinary sex hormone concentrations, and 3) to evaluate the effects of total fat and n3 fatty acid consumption on the associations between sex hormone concentrations and urinary prostaglandin E2 and thromboxane B2 concentrations.
The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. The primary endpoints to be evaluated include plasma and urinary sex hormone concentrations as follows:
Endpoints associates with increased risk factors for breast cancer risk: plasma estradiol (E2), estrone (E1), estrone sulfate (E1 sulfate), testosterone, androstenedione, sex hormone binding globulin (SHBG), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), Measures of estrogen action: plasma follicle stimulating hormone (FSH), urinary estrogen metabolites.
Measures of systemic arachidonic acid-derived eicosanoids: urinary bicyclo-prostaglandin E2 (PGEa), 2,3-dinor thromboxane B2 (TXB2).
Measures reflecting influence of dietary fat and fatty acid intake: plasma phospholipid, cholesterol ester, triglyceride and free fatty acid composition.
- Conditions
- Breast Cancer
- Being tested
- Low Fat diet, Low Fat high n3 diet, High Fat Diet
- Keywords
- omega-3 fatty acids, sex hormones, urinary sex hormone metabolites
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Fat dietOther
Low fat diet = 20% fat
Low Fat high n3 dietOther
Low Fat high n3 diet = 20% fat + 3% n3
High Fat DietOther
High Fat Diet = 40% fat
| Study group | Role | What they receive |
|---|---|---|
| Low Fat, High Fat, Low Fat High Omega 3 | Experimental | See Intervention Description Receives: Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet |
| Low Fat, Low Fat High Omega 3, High Fat | Experimental | See Intervention Description Receives: Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet |
| High Fat, Low Fat, Low Fat High Omega 3 | Experimental | See Intervention Description Receives: Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet |
| High Fat, Low fat High Omega 3, Low Fat | Experimental | See Intervention Description Receives: Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet |
| Low Fat High Omega 3, High Fat, Low Fat | Experimental | See Intervention Description Receives: Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet |
| Low Fat High Omega 3, Low Fat, High Fat | Experimental | See Intervention Description Receives: Other: Low Fat diet; Other: Low Fat high n3 diet; Other: High Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Sex Hormone Levels
Measured: 8 weeks
E2
Estradiol
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJan 2004
- Primary completionDec 2008
- Study completionNov 2010
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 (4)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan K Raatz, PhD, RD, Principal investigator, USDA, GFHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824498
- Sponsor's protocol ID
- UMN914
- Status last verified
- Aug 2018
- First submitted
- 1 Apr 2013
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McColley SP, Georgopoulos A, Young LR, Kurzer MS, Redmon JB, Raatz SK. A high-fat diet and the threonine-encoding allele (Thr54) polymorphism of fatty acid-binding protein 2 reduce plasma triglyceride-rich lipoproteins. Nutr Res. 2011 Jul;31(7):503-8. doi: 10.1016/j.nutres.2011.06.003.
PubMed 21840466Raatz SK, Young LR, Picklo MJ Sr, Sauter ER, Qin W, Kurzer MS. Total dietary fat and fatty acid content modifies plasma phospholipid fatty acids, desaturase activity indices, and urinary prostaglandin E in women. Nutr Res. 2012 Jan;32(1):1-7. doi: 10.1016/j.nutres.2011.12.006.
PubMed 22260857Young LR, Raatz SK, Thomas W, Redmon JB, Kurzer MS. Total dietary fat and omega-3 fatty acids have modest effects on urinary sex hormones in postmenopausal women. Nutr Metab (Lond). 2013 Apr 23;10(1):36. doi: 10.1186/1743-7075-10-36.
PubMed 23618064Young LR, Kurzer MS, Thomas W, Redmon JB, Raatz SK. Effect of dietary fat and omega-3 fatty acids on urinary eicosanoids and sex hormone concentrations in postmenopausal women: a randomized controlled feeding trial. Nutr Cancer. 2011;63(6):930-9. doi: 10.1080/01635581.2011.589957. Epub 2011 Jul 11.
PubMed 21745038
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fat, Eicosanoids and Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT01824498
- Acronym / sponsor ID
- UMN914
- Conditions
- Breast Cancer
- Keywords
- omega-3 fatty acids, sex hormones, urinary sex hormone metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Jan 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 25 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer
Detailed description
The guiding concept of our proposal is that both the total fat and the fatty acid composition of the diet contribute to a milieu associated with the risk for sex-hormone mediated cancers. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer. When compared with the high fat diet, we expect n3 concentrations to increase and sex hormone levels to decrease after both low fat and low fat/n3 rich diets, with the greatest response in the low fat-n3 supplemented group. The aims of this project are: 1) to evaluate the effects of total fat and n3 fatty acid consumption on plasma and urine sex hormone concentrations in postmenopausal women, 2) to evaluate the relationship between plasma concentrations of fatty acids and plasma and urinary sex hormone concentrations, and 3) to evaluate the effects of total fat and n3 fatty acid consumption on the associations between sex hormone concentrations and urinary prostaglandin E2 and thromboxane B2 concentrations.
The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. The primary endpoints to be evaluated include plasma and urinary sex hormone concentrations as follows:
Endpoints associates with increased risk factors for breast cancer risk: plasma estradiol (E2), estrone (E1), estrone sulfate (E1 sulfate), testosterone, androstenedione, sex hormone binding globulin (SHBG), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), Measures of estrogen action: plasma follicle stimulating hormone (FSH), urinary estrogen metabolites.
Measures of systemic arachidonic acid-derived eicosanoids: urinary bicyclo-prostaglandin E2 (PGEa), 2,3-dinor thromboxane B2 (TXB2).
Measures reflecting influence of dietary fat and fatty acid intake: plasma phospholipid, cholesterol ester, triglyceride and free fatty acid composition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low Fat, High Fat, Low Fat High Omega 3 | Experimental | Other: Low Fat diet, Other: Low Fat high n3 diet, Other: High Fat DietSee Intervention Description |
| Low Fat, Low Fat High Omega 3, High Fat | Experimental | Other: Low Fat diet, Other: Low Fat high n3 diet, Other: High Fat DietSee Intervention Description |
| High Fat, Low Fat, Low Fat High Omega 3 | Experimental | Other: Low Fat diet, Other: Low Fat high n3 diet, Other: High Fat DietSee Intervention Description |
| High Fat, Low fat High Omega 3, Low Fat | Experimental | Other: Low Fat diet, Other: Low Fat high n3 diet, Other: High Fat DietSee Intervention Description |
| Low Fat High Omega 3, High Fat, Low Fat | Experimental | Other: Low Fat diet, Other: Low Fat high n3 diet, Other: High Fat DietSee Intervention Description |
| Low Fat High Omega 3, Low Fat, High Fat | Experimental | Other: Low Fat diet, Other: Low Fat high n3 diet, Other: High Fat DietSee Intervention Description |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Postmenopausal women
- 45 to 70 years old,
- at least one year since their last menstrual period
- not using hormone replacement therapy,
- BMI between 19 -29
Key exclusion criteria (2 listed)
- Smoking
- Known disease process, and 3) Use of prescription medications, including hormone replacement therapy.
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 |
|---|---|---|
| Low Fat dietLow fat diet = 20% fat | Other | High Fat, Low Fat, Low Fat High Omega 3, High Fat, Low fat High Omega 3, Low Fat, Low Fat High Omega 3, High Fat, Low Fat, Low Fat High Omega 3, Low Fat, High Fat, Low Fat, High Fat, Low Fat High Omega 3, Low Fat, Low Fat High Omega 3, High Fat |
| Low Fat high n3 dietLow Fat high n3 diet = 20% fat + 3% n3 | Other | High Fat, Low Fat, Low Fat High Omega 3, High Fat, Low fat High Omega 3, Low Fat, Low Fat High Omega 3, High Fat, Low Fat, Low Fat High Omega 3, Low Fat, High Fat, Low Fat, High Fat, Low Fat High Omega 3, Low Fat, Low Fat High Omega 3, High Fat |
| High Fat DietHigh Fat Diet = 40% fat | Other | High Fat, Low Fat, Low Fat High Omega 3, High Fat, Low fat High Omega 3, Low Fat, Low Fat High Omega 3, High Fat, Low Fat, Low Fat High Omega 3, Low Fat, High Fat, Low Fat, High Fat, Low Fat High Omega 3, Low Fat, Low Fat High Omega 3, High Fat |
Primary outcome
Plasma Sex Hormone Levels
Time frame: 8 weeks
E2
Time frame: 8 weeks
Estradiol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21840466McColley SP, Georgopoulos A, Young LR, Kurzer MS, Redmon JB, Raatz SK. A high-fat diet and the threonine-encoding allele (Thr54) polymorphism of fatty acid-binding protein 2 reduce plasma triglyceride-rich lipoproteins. Nutr Res. 2011 Jul;31(7):503-8. doi: 10.1016/j.nutres.2011.06.003.
- Background: PubMed 22260857Raatz SK, Young LR, Picklo MJ Sr, Sauter ER, Qin W, Kurzer MS. Total dietary fat and fatty acid content modifies plasma phospholipid fatty acids, desaturase activity indices, and urinary prostaglandin E in women. Nutr Res. 2012 Jan;32(1):1-7. doi: 10.1016/j.nutres.2011.12.006.
- Background: PubMed 23618064Young LR, Raatz SK, Thomas W, Redmon JB, Kurzer MS. Total dietary fat and omega-3 fatty acids have modest effects on urinary sex hormones in postmenopausal women. Nutr Metab (Lond). 2013 Apr 23;10(1):36. doi: 10.1186/1743-7075-10-36.
- Results publication: PubMed 21745038Young LR, Kurzer MS, Thomas W, Redmon JB, Raatz SK. Effect of dietary fat and omega-3 fatty acids on urinary eicosanoids and sex hormone concentrations in postmenopausal women: a randomized controlled feeding trial. Nutr Cancer. 2011;63(6):930-9. doi: 10.1080/01635581.2011.589957. Epub 2011 Jul 11.
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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.
Susan K Raatz, PhD, RD principal investigator
USDA, GFHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Fat diet, Low Fat high n3 diet and High Fat Diet in people with Breast Cancer, run by USDA Grand Forks Human Nutrition Research Center 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 8 inclusion and 2 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 31 Aug 2018. 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 25 Sep 2013). 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?
Plasma Sex Hormone Levels (time frame: 8 weeks). 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 NCT01824498, which also lists 4 linked publications.
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 31 Aug 2018.