Breast CancerFOODNCT04247763
Fast Food, Fatigue, and Inflammation
A study testing Saturated Fat Meal and Oleic Sunflower Oil Meal in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This double-blind, randomized crossover trial assessed inflammation and fatigue following a fast-food-type meal (saturated fat) compared to a healthier meal (monounsaturated fat) in breast cancer survivors and benign controls (women who had an initial abnormal test for breast cancer). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Saturated Fat Meal and Oleic Sunflower Oil Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2010to 11 Jun 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- We recruited a subset of a larger parent longitudinal observational study to participate in this study. Initially, participants were recruited following an abnormal mammogram, which resulted in either a malignant (cancer group) or benign (non-cancer control group) diagnosis.
Who cannot join
- A history of any prior cancer except basal or squamous cell, chronic obstructive pulmonary disease, evidence of liver or kidney failure, symptomatic ischemic heart disease, significant visual or auditory problems, cognitive impairment, major medical conditions involving the immune system such as diabetes, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, alcohol or drug abuse, marked and recurrent gastrointestinal problems, or regular use of medications with major immunological consequences, e.g., steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Fast Food, Fatigue, and Inflammation: The FOOD Study
This double-blind, randomized crossover trial assessed inflammation and fatigue following a fast-food-type meal (saturated fat) compared to a healthier meal (monounsaturated fat) in breast cancer survivors and benign controls (women who had an initial abnormal test for breast cancer).
- Conditions
- Breast Cancer
- Being tested
- Saturated Fat Meal, Oleic Sunflower Oil Meal
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saturated Fat MealOther
Oleic Sunflower Oil MealOther
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal) | Experimental | Not described Receives: Other: Saturated Fat Meal; Other: Oleic Sunflower Oil Meal |
| Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal) | Active comparator | Not described Receives: Other: Saturated Fat Meal; Other: Oleic Sunflower Oil Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Meal Change in C-reactive Protein
Serum CRP was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Measured: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Post-Meal Change in Serum Amyloid A
Serum Amyloid A was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It as measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Measured: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Change in Intercellular adhesion molecule-1
sICAM-1 was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Measured: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Change in Vascular cell adhesion molecule-1
sVCAM-1 was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Measured: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Fatigue at Follow-Up Visits
The 30-item Multidimensional Fatigue Symptom Inventory-Short form assesses behavioral, cognitive, physical, and affective expressions of fatigue. It provides a very good measure of the multidimensional aspects of fatigue, allows for comparisons between fatigued and non-fatigued individuals, and has subscales measuring general, physical, emotional, mental, and vigor aspects of fatigue, as well as a total score.
Measured: The survey was administered upon admission to the Clinical Research Center before the meal at both visits and at 18- and 30-month follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start13 Dec 2010
- Primary completion11 Jun 2013
- Study completion11 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover trial: participants were randomized to sequence of meal type; they ate one high saturated fat meal and one high oleic sunflower oil meal with 1-4 weeks washout in between meals
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janice Kiecolt-Glaser, Ohio State University Comprehensive Cancer Center
- Investigators
- Janice Kiecolt-Glaser, Principal investigator, Ohio State Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247763
- Sponsor's protocol ID
- OSU-10078
- Other IDs
- NCI-2014-01312
- Acronym
- FOOD
- Status last verified
- Aug 2023
- First submitted
- 28 Jan 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madison AA, Belury MA, Andridge R, Shrout MR, Renna ME, Malarkey WB, Bailey MT, Kiecolt-Glaser JK. Afternoon distraction: a high-saturated-fat meal and endotoxemia impact postmeal attention in a randomized crossover trial. Am J Clin Nutr. 2020 Jun 1;111(6):1150-1158. doi: 10.1093/ajcn/nqaa085.
PubMed 32393980
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Food, Fatigue, and Inflammation: The FOOD Study
- ClinicalTrials.gov ID
- NCT04247763
- Acronym / sponsor ID
- FOOD / OSU-10078
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Dec 2010 (actual)
- Primary completion
- 11 Jun 2013 (actual)
- Study completion
- 11 Jun 2013 (actual)
- First posted
- 30 Jan 2020 (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.
This double-blind, randomized crossover trial assessed inflammation and fatigue following a fast-food-type meal (saturated fat) compared to a healthier meal (monounsaturated fat) in breast cancer survivors and benign controls (women who had an initial abnormal test for breast cancer).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized crossover trial: participants were randomized to sequence of meal type; they ate one high saturated fat meal and one high oleic sunflower oil meal with 1-4 weeks washout in between meals
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal) | Experimental | Other: Saturated Fat Meal, Other: Oleic Sunflower Oil Meal |
| Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal) | Active comparator | Other: Saturated Fat Meal, Other: Oleic Sunflower Oil Meal |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- We recruited a subset of a larger parent longitudinal observational study to participate in this study. Initially, participants were recruited following an abnormal mammogram, which resulted in either a malignant (cancer group) or benign (non-cancer control group) diagnosis.
Key exclusion criteria (1 listed)
- A history of any prior cancer except basal or squamous cell, chronic obstructive pulmonary disease, evidence of liver or kidney failure, symptomatic ischemic heart disease, significant visual or auditory problems, cognitive impairment, major medical conditions involving the immune system such as diabetes, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, alcohol or drug abuse, marked and recurrent gastrointestinal problems, or regular use of medications with major immunological consequences, e.g., steroids.
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 |
|---|---|---|
| Saturated Fat Meal | Other | Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal), Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal) |
| Oleic Sunflower Oil Meal | Other | Arm 1 (Saturated Fat Meal, Oleic Sunflower Oil Meal), Arm 2 (Oleic Sunflower Oil Meal, Saturated Fat Meal) |
Primary outcome
Post-Meal Change in C-reactive Protein
Time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Serum CRP was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Post-Meal Change in Serum Amyloid A
Time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
Serum Amyloid A was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It as measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Change in Intercellular adhesion molecule-1
Time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
sICAM-1 was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Change in Vascular cell adhesion molecule-1
Time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal
sVCAM-1 was obtained from blood drawn before the meal as well as 2, 4, and 7 hours post-meal. It was measured with the Vascular Injury Panel 2 Multispot Kit on an MSD Imager 2400 (both Meso Scale Discovery, Rockville, MD, USA), following kit instructions.
Fatigue at Follow-Up Visits
Time frame: The survey was administered upon admission to the Clinical Research Center before the meal at both visits and at 18- and 30-month follow-up visits.
The 30-item Multidimensional Fatigue Symptom Inventory-Short form assesses behavioral, cognitive, physical, and affective expressions of fatigue. It provides a very good measure of the multidimensional aspects of fatigue, allows for comparisons between fatigued and non-fatigued individuals, and has subscales measuring general, physical, emotional, mental, and vigor aspects of fatigue, as well as a total score.
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 6 Sep 2023.
- Derived from this study: PubMed 32393980Madison AA, Belury MA, Andridge R, Shrout MR, Renna ME, Malarkey WB, Bailey MT, Kiecolt-Glaser JK. Afternoon distraction: a high-saturated-fat meal and endotoxemia impact postmeal attention in a randomized crossover trial. Am J Clin Nutr. 2020 Jun 1;111(6):1150-1158. doi: 10.1093/ajcn/nqaa085.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Janice Kiecolt-Glaser principal investigator
Ohio State 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 study testing Saturated Fat Meal and Oleic Sunflower Oil Meal in people with Breast Cancer, 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 1 inclusion and 1 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 6 Sep 2023. 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?
Post-Meal Change in C-reactive Protein (time frame: Blood samples were obtained before the meal (baseline) as well as 2, 4, and 7 hours post-meal). The study lists 5 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 NCT04247763, 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 6 Sep 2023.