Breast CancerPhase 3LEAFNCT01559194
Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk
A Phase 3 study testing Low Fat Diet plus exercise and Low Carbohydrate diet + Exercise in people with Breast Cancer and Weight Loss, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Weight Loss
- What is being tested?
- Low Fat Diet plus exercise and Low Carbohydrate diet + Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Dec 2007
- Phase
- Phase 3
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 30 and older
- Premenopausal (may be confirmed by FSH)
- No previous diagnosis of cancer (except non-melanomatous skin cancer)
- Body mass index between 25-34 kg/m2
- Women must be expected to live in the Columbus area for the next 18 months.
- All women must present a letter of medical clearance from their primary care physician.
Who cannot join
- Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.
- Women who are already participating in a formal weight loss program (such as Weight Watchers)will not be eligible.
- Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.
- All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of a Low Fat or Low Carbohydrate Dietary Pattern for Weight Loss and Impact on Biomarkers Associated With Breast Cancer Risk in Overweight and Obese Premenopausal Women: Lifestyle Eating and Fitness
The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk.
Read the detailed description
We examined a low carbohydrate diet (40% carbohydrates, 30% protein, 30% fat) versus a low fat diet (60% carbohydrates, 20% protein, 20% fat) to determine the impact of these dietary patterns, combined with exercise, on weight loss, body shape and body composition.
Inclusion Criteria:
- Aged 30 and older
- Premenopausal (may be confirmed by FSH)
- No previous diagnosis of cancer (except non-melanomatous skin cancer)
- Body mass index between 25-34 kg/m2
- Women must be expected to live in the Columbus area for the next 18 months
- All women must present a letter of medical clearance from their primary care physician
Exclusion Criteria:
- Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.
- Women who are already participating in a formal weight loss program (such as Weight Watchers) will not be eligible.
- Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.
- All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.
- Conditions
- Breast Cancer, Weight Loss
- Being tested
- Low Fat Diet plus exercise, Low Carbohydrate diet + Exercise
- Medical subject headings
- Breast Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Fat Diet plus exerciseBehavioural
Low fat diet plus exercise - Subjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.
Low Carbohydrate diet + ExerciseBehavioural
Low carbohydrate diet plus exercise: Subjects were educated about a low carbohydrate diet and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.
| Study group | Role | What they receive |
|---|---|---|
| Low Fat Diet + Exercise | Active comparator | Subjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day. Receives: Behavioral: Low Fat Diet plus exercise |
| Low Carbohydrate Diet + Exercise | Active comparator | Subjects were educated about a low carbohydrate diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day. Receives: Behavioral: Low Carbohydrate diet + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women who lose weight when following 1 of 2 different calorie-restricted diets
Measured: 18 months
Secondary outcomes (1)
Number of women that long-term weight loss impacted biomarkers (including Insulin-like growth factor (IGF)- 1 and IGFBP-3) associated with breast cancer risk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMay 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra D. Paskett, PhD, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559194
- Sponsor's protocol ID
- LEAF
- Other IDs
- OSU 0372
- Acronym
- LEAF
- Status last verified
- Apr 2014
- First submitted
- 19 Mar 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
David P, Buckworth J, Pennell ML, Katz ML, DeGraffinreid CR, Paskett ED. A walking intervention for postmenopausal women using mobile phones and Interactive Voice Response. J Telemed Telecare. 2012 Jan;18(1):20-5. doi: 10.1258/jtt.2011.110311. Epub 2011 Nov 3.
PubMed 22052963Llanos AA, Krok JL, Peng J, Pennell ML, Vitolins MZ, Degraffinreid CR, Paskett ED. Effects of a walking intervention using mobile technology and interactive voice response on serum adipokines among postmenopausal women at increased breast cancer risk. Horm Cancer. 2014 Apr;5(2):98-103. doi: 10.1007/s12672-013-0168-4. Epub 2014 Jan 17.
PubMed 24435584Foraker RE, Pennell M, Sprangers P, Vitolins MZ, DeGraffinreid C, Paskett ED. Effect of a low-fat or low-carbohydrate weight-loss diet on markers of cardiovascular risk among premenopausal women: a randomized trial. J Womens Health (Larchmt). 2014 Aug;23(8):675-80. doi: 10.1089/jwh.2013.4638. Epub 2014 Jul 16.
PubMed 25029619Llanos AA, Krok JL, Peng J, Pennell ML, Olivo-Marston S, Vitolins MZ, Degraffinreid CR, Paskett ED. Favorable effects of low-fat and low-carbohydrate dietary patterns on serum leptin, but not adiponectin, among overweight and obese premenopausal women: a randomized trial. Springerplus. 2014 Apr 4;3:175. doi: 10.1186/2193-1801-3-175. eCollection 2014.
PubMed 24790820
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of a Low Fat or Low Carbohydrate Dietary Pattern for Weight Loss and Impact on Biomarkers Associated With Breast Cancer Risk in Overweight and Obese Premenopausal Women: Lifestyle Eating and Fitness
- ClinicalTrials.gov ID
- NCT01559194
- Acronym / sponsor ID
- LEAF / LEAF
- Conditions
- Breast Cancer, Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- May 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Mar 2012 (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 primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk.
Detailed description
We examined a low carbohydrate diet (40% carbohydrates, 30% protein, 30% fat) versus a low fat diet (60% carbohydrates, 20% protein, 20% fat) to determine the impact of these dietary patterns, combined with exercise, on weight loss, body shape and body composition.
Inclusion Criteria:
- Aged 30 and older
- Premenopausal (may be confirmed by FSH)
- No previous diagnosis of cancer (except non-melanomatous skin cancer)
- Body mass index between 25-34 kg/m2
- Women must be expected to live in the Columbus area for the next 18 months
- All women must present a letter of medical clearance from their primary care physician
Exclusion Criteria:
- Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.
- Women who are already participating in a formal weight loss program (such as Weight Watchers) will not be eligible.
- Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.
- All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Fat Diet + Exercise | Active comparator | Behavioral: Low Fat Diet plus exerciseSubjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day. |
| Low Carbohydrate Diet + Exercise | Active comparator | Behavioral: Low Carbohydrate diet + ExerciseSubjects were educated about a low carbohydrate diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 30 and older
- Premenopausal (may be confirmed by FSH)
- No previous diagnosis of cancer (except non-melanomatous skin cancer)
- Body mass index between 25-34 kg/m2
- Women must be expected to live in the Columbus area for the next 18 months.
Key exclusion criteria (4 listed)
- Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.
- Women who are already participating in a formal weight loss program (such as Weight Watchers)will not be eligible.
- Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.
- All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.
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 Diet plus exerciseLow fat diet plus exercise - Subjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day. | Behavioural | Low Fat Diet + Exercise |
| Low Carbohydrate diet + ExerciseLow carbohydrate diet plus exercise: Subjects were educated about a low carbohydrate diet and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day. | Behavioural | Low Carbohydrate Diet + Exercise |
Primary outcome
Number of women who lose weight when following 1 of 2 different calorie-restricted diets
Time frame: 18 months
1 secondary outcome
Number of women that long-term weight loss impacted biomarkers (including Insulin-like growth factor (IGF)- 1 and IGFBP-3) associated with breast cancer risk
Time frame: 12 months
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 14 Apr 2014.
- Results publication: PubMed 22052963David P, Buckworth J, Pennell ML, Katz ML, DeGraffinreid CR, Paskett ED. A walking intervention for postmenopausal women using mobile phones and Interactive Voice Response. J Telemed Telecare. 2012 Jan;18(1):20-5. doi: 10.1258/jtt.2011.110311. Epub 2011 Nov 3.
- Results publication: PubMed 24435584Llanos AA, Krok JL, Peng J, Pennell ML, Vitolins MZ, Degraffinreid CR, Paskett ED. Effects of a walking intervention using mobile technology and interactive voice response on serum adipokines among postmenopausal women at increased breast cancer risk. Horm Cancer. 2014 Apr;5(2):98-103. doi: 10.1007/s12672-013-0168-4. Epub 2014 Jan 17.
- Derived from this study: PubMed 25029619Foraker RE, Pennell M, Sprangers P, Vitolins MZ, DeGraffinreid C, Paskett ED. Effect of a low-fat or low-carbohydrate weight-loss diet on markers of cardiovascular risk among premenopausal women: a randomized trial. J Womens Health (Larchmt). 2014 Aug;23(8):675-80. doi: 10.1089/jwh.2013.4638. Epub 2014 Jul 16.
- Derived from this study: PubMed 24790820Llanos AA, Krok JL, Peng J, Pennell ML, Olivo-Marston S, Vitolins MZ, Degraffinreid CR, Paskett ED. Favorable effects of low-fat and low-carbohydrate dietary patterns on serum leptin, but not adiponectin, among overweight and obese premenopausal women: a randomized trial. Springerplus. 2014 Apr 4;3:175. doi: 10.1186/2193-1801-3-175. eCollection 2014.
- JameslineLink provided by the sponsor.
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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.
Electra D. Paskett, PhD principal investigator
The Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low Fat Diet plus exercise and Low Carbohydrate diet + Exercise in people with Breast Cancer and Weight Loss, run by Ohio State University Comprehensive Cancer 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 6 inclusion and 4 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 14 Apr 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of women who lose weight when following 1 of 2 different calorie-restricted diets (time frame: 18 months). 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 NCT01559194, 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 14 Apr 2014.