Functional Medicine Intervention in Improving Wound Healing in Patients Undergoing Breast Reconstruction

Inclusion Criteria

• Women >= 18 years of age at screening
• Undergoing uni- or bilateral delayed abdominally-based breast reconstruction at the Cleveland Clinic
• Women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study
• Capable of providing written informed consent prior to any protocol-specified procedures
• Willing to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

• Body mass index (BMI) >= 37
• Women who are pregnant, nursing, or planning pregnancy during the trial
• Have a serious concomitant illness that could interfere with the subject’s participation in the trial (allergy preventing supplement usage)
• Undergoing chemotherapy during proposed nutritional intervention (3 months before or after surgery)
• Are unable to or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access
• Clinical diagnosis of cognitive impairment or dementia
• Known sensitivity to dietary supplements
• Currently taking the following medications: * Anti-epileptic agents (ex. Dilantin) * Calcium channel blockers (ex. Amlodipine, Diltiazem, etc.) * Anti-rheumatic agents, or disease-modifying antirheumatic drugs (DMARDs) (ex. Sulfasalazine) * Chemotherapeutic agents (ex. topoisomerase I inhibitors) * Hormone replacement therapy * Anticoagulant or antiplatelet therapy (ex. Plavix or Coumadin) * Atrial fibrillation therapy (ex. Verapamil) * Dopamine replacement therapy (ex. Levodopa)
• History of being seen or had intervention/care in functional medicine or following functional medicine principles
• Currently participating in a supervised diet program
• Use of any investigational drug within 30 days prior to randomization or within 5 half-lives of the investigational agent, whichever is longer