Contemporary clinical trials · 2026
Rationale and study protocol for a randomized controlled MIND diet feeding trial for breast cancer-related cognitive impairment.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Crowder Sylvia L, Hu Bihe, Hoogland Aasha I, Li Xiaoyin, Rodriguez Yvelise, Bryant Crystal, Varghese Deepthi M, Simon Danielle F, Reese Samantha A, Carson Tiffany L, Han Hyo S, Small Brent J, Jim Heather S L
Аннотация
BACKGROUND: Despite well-documented cancer-related cognitive impairment (CRCI) burden, few efficacious interventions exist to mitigate CRCI. Biological mechanisms include inflammation and oxidative stress, which may be influenced by diet. Dietary interventions could be highly disseminable and acceptable, but have not been evaluated for CRCI. This study will examine the efficacy of a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet on CRCI.
METHODS: Breast cancer survivors will be eligible if they have completed adjuvant treatment 6 months to three years previously, self-reported CRCI, and low adherence to the MIND diet. Participants (N = 200) will be randomized 1:1 to a 12-week feeding trial of the MIND diet versus their usual diet. To achieve maximal effect, the study consists of two 12-week phases: 1) intervention phase, MIND diet meals will be provided with skill coaching, and 2) maintenance phase, determine the extent of the diet in maintaining cognition to determine efficacy and future scalability. Subjective cognition will be evaluated as the primary outcome. Secondary outcomes include objective CRCI, self-reported fatigue, mood, and quality of life. Assessments will occur immediately before the intervention (baseline), at the end of the intervention phase (first 12-week phase), and end of the maintenance phase (second 12-week phase).
DISCUSSION: Findings will describe the relationship between diet and CRCI and provide a novel examination of the MIND diet as a strategy to mitigate CRCI. Results have potential to influence clinical practice, translational research, and public health efforts aimed at developing medical nutrition therapy guidelines tailored to this population.
TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov, identifier NCT07018986, on 2025-06-13.
METHODS: Breast cancer survivors will be eligible if they have completed adjuvant treatment 6 months to three years previously, self-reported CRCI, and low adherence to the MIND diet. Participants (N = 200) will be randomized 1:1 to a 12-week feeding trial of the MIND diet versus their usual diet. To achieve maximal effect, the study consists of two 12-week phases: 1) intervention phase, MIND diet meals will be provided with skill coaching, and 2) maintenance phase, determine the extent of the diet in maintaining cognition to determine efficacy and future scalability. Subjective cognition will be evaluated as the primary outcome. Secondary outcomes include objective CRCI, self-reported fatigue, mood, and quality of life. Assessments will occur immediately before the intervention (baseline), at the end of the intervention phase (first 12-week phase), and end of the maintenance phase (second 12-week phase).
DISCUSSION: Findings will describe the relationship between diet and CRCI and provide a novel examination of the MIND diet as a strategy to mitigate CRCI. Results have potential to influence clinical practice, translational research, and public health efforts aimed at developing medical nutrition therapy guidelines tailored to this population.
TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov, identifier NCT07018986, on 2025-06-13.