Breast CancerNCT05113485
UCLA Breast Cancer Survivor Health Promotion Research Study
A study testing Diabetes Prevention Program-based lifestyle change intervention (DPP) and Highly Microbiota-Accessible Foods (HMAFs) intervention in people with Breast Cancer, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Pilot randomized controlled parallel group behavior change comparative effectiveness trial involves 30 breast cancer survivors interested in losing excess body fat. Both interventions include dietary + exercise prescriptions that hold promise for reducing the survivors' risk of cancer recurrence. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diabetes Prevention Program-based lifestyle change intervention (DPP) and Highly Microbiota-Accessible Foods (HMAFs) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to Jun 2023
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 6 months since breast cancer diagnosis and up to 4 years since diagnosis.
- Between 50 and 75 years of age.
- Diagnosed with localized steroid hormone receptor-positive breast cancer, up to stage IIIa.
- At least 6 months post chemotherapy or radiation treatment.
- Subjects must be in good health as determined by medical history, physical examination, and clinical laboratory measurements.
- No broad-spectrum antibiotic use in the last two months.
- Body mass index between 27 and 38 based on self-reported height and weight and between 25 and 40 based on objective assessment of height and weight.
- Willing to complete assessments at baseline, 3 months and 6 months follow-up
Who cannot join
- Diagnosed with metastatic breast cancer
- Currently undergoing chemotherapy or radiation treatment
- Immunoglobulin-E (IgE)-mediated food allergies, or any medical condition requiring mandatory dietary restrictions
- Significant cardiac, pulmonary, renal, liver or psychiatric disease.
- Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UCLA Center for Cancer Prevention & Control Research
Los Angeles, California, 90095-6900
Wendy Rue, B.A., 310-825-4487, wrue@ucla.edu
Jacqueline Wong, B.A., 310-794-9320, jcwong@ucla.edu
About this study
Official title: A Fiber-diverse, Anti-inflammatory Diet and Aerobic Exercise Reduce Risk of Breast Cancer Recurrence
Pilot randomized controlled parallel group behavior change comparative effectiveness trial involves 30 breast cancer survivors interested in losing excess body fat. Both interventions include dietary + exercise prescriptions that hold promise for reducing the survivors' risk of cancer recurrence. Both interventions are consistent with the Dietary Guidelines for Americans but the Diabetes Prevention Program (DPP)-based approach focuses on weight loss through calorie restriction and increased physical activity while the Highly Microbiota-Accessible Foods (HMAFs) approach is intended to be a low-numeracy version of a Mediterranean-style diet and increased physical activity. The DPP approach is considered to be a high-numeracy intervention because it requires that consumers keep track of all calories consumed and expended per day and to endeavor to maintain a calorie deficit each day during the active weight loss phase. For both conditions, the 12 to 13-week intervention includes 2 virtual home visits, 2 virtual group education sessions and 7 telephone or Zoom-based coaching sessions by well-trained intervenors. Assessments occur at baseline and six months, with systemic inflammation (high sensitivity C-reactive protein) being the primary outcome measure and visceral fat being a secondary outcome. Other prespecified secondary outcomes include gut microbiota alpha-1 diversity, insulin resistance, HDL-cholesterol, daily count of highly microbiota-accessible foods, waist circumference, BMI, systolic blood pressure, ratio of fecal Proteobacteria to short chain fatty acid-generating bacteria and health-related quality of life.
Read the detailed description
Background. The human gut microbiota influences obesity status and inflammation, two major risk factors for postmenopausal breast cancer recurrence. Whether an exercise and dietary intervention designed to optimize gut microbiota composition might reduce risk for breast cancer recurrence is unknown. To improve the gut microbiota composition, the investigators propose teaching postmenopausal breast cancer survivors to allocate about 20% of their daily calorie intake to consuming a daily count of six fiber-rich, minimally processed, plant-based food choices that comply with federal MyPlate.gov diet recommendations. Preliminary data suggest that the investigators' Highly-Microbiota-Accessible Foods (HMAFs) approach will yield cardiometabolic outcomes equal to or better than those achieved by the traditional Diabetes Prevention Program (DPP) calorie restriction approach at 6 months follow-up. Because breast cancer recurrence risk covaries with cardiometabolic risks, the lower cardiometabolic risk of the HMAFs approach should be associated with reduced risk of breast cancer recurrence.
Hypotheses. The greater diversity of fiber-rich, minimally processed plant foods consumed in the HMAFs condition relative to the DPP condition will result in greater changes in HMAFs participants compared to DPP participants from baseline to 6 months follow-up in the following measures: (primary hypothesis) reduce high sensitivity C-reactive protein, (secondary hypotheses) reduce visceral body fat and increase alpha-1 diversity of gut microbes and increase health-related quality of life.
To test these hypotheses, the research objectives include the following specific aims: 1) Recruit a diverse sample of 30 overweight or obese postmenopausal survivors with stage I, II and IIIa breast cancer; randomly allocate them to two lifestyle change intervention conditions, 2) Obtain baseline and 6-month follow-up assessments of: low grade systemic inflammation, body composition including visceral fat estimation, cardiorespiratory fitness, inflammatory and cardiometabolic biomarkers, fecal samples, and quality of life, 3) Conduct two parallel, three-month behavior change interventions, contrasting the 6-count HMAFs approach with the traditional DPP calorie restriction approach , and 4) Use results to design a ramped-up randomized factorial trial.
If hypotheses are confirmed, the low-numeracy HMAFs approach may, for low-income survivors, be a practical alternative to traditional high-numeracy calorie restriction approaches to reducing risk of breast cancer recurrence.
- Conditions
- Breast Cancer
- Being tested
- Diabetes Prevention Program-based lifestyle change intervention (DPP), Highly Microbiota-Accessible Foods (HMAFs) intervention
- Keywords
- obesity, physical activity, fiber diversity, calorie restriction, inflammation
- Medical subject headings
- Breast Neoplasms, Obesity, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention Program-based lifestyle change intervention (DPP)Behavioural
The DPP condition consists of 11 health education sessions over 12 weeks, including 2 virtual home visits, two virtual group education sessions and 7 telephone coaching calls. These sessions will teach DPP-based lessons on how to lose excess body fat through calorie restriction and increased physical activity. All dietary and physical activity recommendations are intended to be consistent with federal nutrition and physical activity guidelines.
Highly Microbiota-Accessible Foods (HMAFs) interventionBehavioural
The Highly Microbiota-Accessible Foods (HMAFs) intervention approach includes 11 health education sessions, including two virtual home visits, two virtual group education sessions, and 7 telephone coaching sessions. These sessions are designed to help study participants to identify and consume optimally 6 daily instances of minimally processed, fiber-rich food sources, drawn from all four of the MyPlate.gov categories: vegetables, fruits, whole grains and plant-based protein-rich foods (e.g., legumes, nuts and seeds). Increased physical activity is also recommended as a way to optimize the microbial conversion of fiber-rich food sources to short chain fatty acids, which are then expected to reduce excess low-grade inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Prevention Program-based lifestyle change intervention (DPP) | Active comparator | The Diabetes Prevention Program-based lifestyle change intervention (DPP) is designed to help overweight breast cancer survivors to reduce their risk of breast cancer recurrence by reducing their excess body fat. Receives: Behavioral: Diabetes Prevention Program-based lifestyle change intervention (DPP) |
| Highly Microbiota-Accessible Foods (HMAFs) intervention | Experimental | The Highly Microbiota-Accessible Foods (HMAFs) lifestyle change intervention is designed to help overweight breast cancer survivors reduce their risk of breast cancer recurrence by reducing their elevated low-grade inflammation. Receives: Behavioral: Highly Microbiota-Accessible Foods (HMAFs) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-sensitivity C-Reactive Protein (CRP)
CRP is commonly used by researchers as a biomarker for systemic inflammation.
Measured: Change from baseline to 6 months follow-up
Secondary outcomes (3)
Visceral fat as assessed by DXA
Visceral fat is also known as intra-abdominal fat. It is located inside the peritoneal cavity, packed in between internal organs and torso. It is the most metabolically active adipose tissue and positively associated with systemic inflammation.
Measured: Change from baseline to six months follow-up
Shannon index of alpha diversity of fecal microbial species
Fecal DNA from the V4 region of the 16S ribosomal RNA will be amplified, sequenced and filtered for quality before statistical analysis. The Shannon index measures both gene richness and evenness.
Measured: Change from baseline to six months follow-up
Number of highly microbiota-accessible foods consumed per day
From participants' 24-hour diet recalls - The daily sum of different carbohydrate-rich food sources minimally processed and unaccompanied by pro-inflammatory components, especially saturated fat and added sugar.
Measured: Change from baseline to six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Apr 2022
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The two lifestyle change interventions feature a similar exercise prescription and the same sequence of intervention contacts (2 virtual home visits; 2 virtual group education sessions, 7 individual telephone coaching sessions) but differ in dietary approach. The DPP-based diet approach prescribes desired weight loss in overweight breast cancer survivors by restricting daily calorie intake and promoting increased calorie expenditure via physical activity. The HMAFs approach prescribes consuming an optimal six microbiota-accessible foods unaccompanied by pro-inflammatory food components such as saturated fat or added sugar as well as engaging regularly in exercise that elevates the heart rate and reduces inflammation. Only 20 percent of daily calories need to be devoted to HMAFs; the remaining calories can come from daily food choices conforming to the 2020-2025 Dietary Guidelines for Americans.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William J. McCarthy, Ph.D., University of California, Los Angeles
- Investigators
- William J. McCarthy, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113485
- Sponsor's protocol ID
- B27IB3856
- Status last verified
- Apr 2022
- First submitted
- 19 Oct 2021
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be posted on the website of the UCLA Fielding School of Public Health for access by students and other investigators. Primary and secondary outcomes and demographic characteristics will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fiber-diverse, Anti-inflammatory Diet and Aerobic Exercise Reduce Risk of Breast Cancer Recurrence
- ClinicalTrials.gov ID
- NCT05113485
- Acronym / sponsor ID
- B27IB3856
- Conditions
- Breast Cancer
- Keywords
- obesity, physical activity, fiber diversity, calorie restriction, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 9 Nov 2021 (actual)
- 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.
Pilot randomized controlled parallel group behavior change comparative effectiveness trial involves 30 breast cancer survivors interested in losing excess body fat. Both interventions include dietary + exercise prescriptions that hold promise for reducing the survivors' risk of cancer recurrence. Both interventions are consistent with the Dietary Guidelines for Americans but the Diabetes Prevention Program (DPP)-based approach focuses on weight loss through calorie restriction and increased physical activity while the Highly Microbiota-Accessible Foods (HMAFs) approach is intended to be a low-numeracy version of a Mediterranean-style diet and increased physical activity. The DPP approach is considered to be a high-numeracy intervention because it requires that consumers keep track of all calories consumed and expended per day and to endeavor to maintain a calorie deficit each day during the active weight loss phase. For both conditions, the 12 to 13-week intervention includes 2 virtual home visits, 2 virtual group education sessions and 7 telephone or Zoom-based coaching sessions by well-trained intervenors. Assessments occur at baseline and six months, with systemic inflammation (high sensitivity C-reactive protein) being the primary outcome measure and visceral fat being a secondary outcome. Other prespecified secondary outcomes include gut microbiota alpha-1 diversity, insulin resistance, HDL-cholesterol, daily count of highly microbiota-accessible foods, waist circumference, BMI, systolic blood pressure, ratio of fecal Proteobacteria to short chain fatty acid-generating bacteria and health-related quality of life.
Detailed description
Background. The human gut microbiota influences obesity status and inflammation, two major risk factors for postmenopausal breast cancer recurrence. Whether an exercise and dietary intervention designed to optimize gut microbiota composition might reduce risk for breast cancer recurrence is unknown. To improve the gut microbiota composition, the investigators propose teaching postmenopausal breast cancer survivors to allocate about 20% of their daily calorie intake to consuming a daily count of six fiber-rich, minimally processed, plant-based food choices that comply with federal MyPlate.gov diet recommendations. Preliminary data suggest that the investigators' Highly-Microbiota-Accessible Foods (HMAFs) approach will yield cardiometabolic outcomes equal to or better than those achieved by the traditional Diabetes Prevention Program (DPP) calorie restriction approach at 6 months follow-up. Because breast cancer recurrence risk covaries with cardiometabolic risks, the lower cardiometabolic risk of the HMAFs approach should be associated with reduced risk of breast cancer recurrence.
Hypotheses. The greater diversity of fiber-rich, minimally processed plant foods consumed in the HMAFs condition relative to the DPP condition will result in greater changes in HMAFs participants compared to DPP participants from baseline to 6 months follow-up in the following measures: (primary hypothesis) reduce high sensitivity C-reactive protein, (secondary hypotheses) reduce visceral body fat and increase alpha-1 diversity of gut microbes and increase health-related quality of life.
To test these hypotheses, the research objectives include the following specific aims: 1) Recruit a diverse sample of 30 overweight or obese postmenopausal survivors with stage I, II and IIIa breast cancer; randomly allocate them to two lifestyle change intervention conditions, 2) Obtain baseline and 6-month follow-up assessments of: low grade systemic inflammation, body composition including visceral fat estimation, cardiorespiratory fitness, inflammatory and cardiometabolic biomarkers, fecal samples, and quality of life, 3) Conduct two parallel, three-month behavior change interventions, contrasting the 6-count HMAFs approach with the traditional DPP calorie restriction approach , and 4) Use results to design a ramped-up randomized factorial trial.
If hypotheses are confirmed, the low-numeracy HMAFs approach may, for low-income survivors, be a practical alternative to traditional high-numeracy calorie restriction approaches to reducing risk of breast cancer recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The two lifestyle change interventions feature a similar exercise prescription and the same sequence of intervention contacts (2 virtual home visits; 2 virtual group education sessions, 7 individual telephone coaching sessions) but differ in dietary approach. The DPP-based diet approach prescribes desired weight loss in overweight breast cancer survivors by restricting daily calorie intake and promoting increased calorie expenditure via physical activity. The HMAFs approach prescribes consuming an optimal six microbiota-accessible foods unaccompanied by pro-inflammatory food components such as saturated fat or added sugar as well as engaging regularly in exercise that elevates the heart rate and reduces inflammation. Only 20 percent of daily calories need to be devoted to HMAFs; the remaining calories can come from daily food choices conforming to the 2020-2025 Dietary Guidelines for Americans.
| Arm | Type | Receives |
|---|---|---|
| Diabetes Prevention Program-based lifestyle change intervention (DPP) | Active comparator | Behavioral: Diabetes Prevention Program-based lifestyle change intervention (DPP)The Diabetes Prevention Program-based lifestyle change intervention (DPP) is designed to help overweight breast cancer survivors to reduce their risk of breast cancer recurrence by reducing their excess body fat. |
| Highly Microbiota-Accessible Foods (HMAFs) intervention | Experimental | Behavioral: Highly Microbiota-Accessible Foods (HMAFs) interventionThe Highly Microbiota-Accessible Foods (HMAFs) lifestyle change intervention is designed to help overweight breast cancer survivors reduce their risk of breast cancer recurrence by reducing their elevated low-grade inflammation. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 6 months since breast cancer diagnosis and up to 4 years since diagnosis.
- Between 50 and 75 years of age.
- Diagnosed with localized steroid hormone receptor-positive breast cancer, up to stage IIIa.
- At least 6 months post chemotherapy or radiation treatment.
- Subjects must be in good health as determined by medical history, physical examination, and clinical laboratory measurements.
Key exclusion criteria (5 listed)
- Diagnosed with metastatic breast cancer
- Currently undergoing chemotherapy or radiation treatment
- Immunoglobulin-E (IgE)-mediated food allergies, or any medical condition requiring mandatory dietary restrictions
- Significant cardiac, pulmonary, renal, liver or psychiatric disease.
- Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise
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 |
|---|---|---|
| Diabetes Prevention Program-based lifestyle change intervention (DPP)The DPP condition consists of 11 health education sessions over 12 weeks, including 2 virtual home visits, two virtual group education sessions and 7 telephone coaching calls. These sessions will teach DPP-based lessons on how to lose excess body fat through calorie restriction and increased physical activity. All dietary and physical activity recommendations are intended to be consistent with federal nutrition and physical activity guidelines. | Behavioural | Diabetes Prevention Program-based lifestyle change intervention (DPP) |
| Highly Microbiota-Accessible Foods (HMAFs) interventionThe Highly Microbiota-Accessible Foods (HMAFs) intervention approach includes 11 health education sessions, including two virtual home visits, two virtual group education sessions, and 7 telephone coaching sessions. These sessions are designed to help study participants to identify and consume optimally 6 daily instances of minimally processed, fiber-rich food sources, drawn from all four of the MyPlate.gov categories: vegetables, fruits, whole grains and plant-based protein-rich foods (e.g., legumes, nuts and seeds). Increased physical activity is also recommended as a way to optimize the microbial conversion of fiber-rich food sources to short chain fatty acids, which are then expected to reduce excess low-grade inflammation. | Behavioural | Highly Microbiota-Accessible Foods (HMAFs) intervention |
Primary outcome
High-sensitivity C-Reactive Protein (CRP)
Time frame: Change from baseline to 6 months follow-up
CRP is commonly used by researchers as a biomarker for systemic inflammation.
3 secondary outcomes
Visceral fat as assessed by DXA
Time frame: Change from baseline to six months follow-up
Shannon index of alpha diversity of fecal microbial species
Time frame: Change from baseline to six months follow-up
Number of highly microbiota-accessible foods consumed per day
Time frame: Change from baseline to six months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Yes. De-identified data will be posted on the website of the UCLA Fielding School of Public Health for access by students and other investigators. Primary and secondary outcomes and demographic characteristics will be shared.
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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.
William J. McCarthy principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Program-based lifestyle change intervention (DPP) and Highly Microbiota-Accessible Foods (HMAFs) intervention in people with Breast Cancer, run by University of California, Los Angeles 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 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William J. McCarthy, Ph.D. (3107947587, wmccarth@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-sensitivity C-Reactive Protein (CRP) (time frame: Change from baseline to 6 months follow-up). 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 11 Apr 2022.