2.1. Study Design and Participant Eligibility
dizziness/fainting, stroke, cancer, allergy, HIV, liver or renal dysfunction, hepatitis, substance abuse
CELIAC DISEASE, CARDIAC EVENT, LACTOSE INTOLERANCE, CANCER, STROKE, ALLERGY, INTESTINAL DISORDERS, CHRONIC DISEASES, RECRUITMENT, GLUTEN SENSITIVITY, HEPATITIS
This study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Institutional Review Board (IRB2019-0597F) at Texas A&M University. This study was registered at clinicaltrials.gov as NCT05586386. Participants were recruited between January 2020 and August 2021 according to the following inclusion criteria: Age: ≥18 years old, body mass index (BMI): ≥30 and ≤40, without a history of chronic diseases or intestinal disorders, and with a willingness to stop taking nutritional supplements. Participants were excluded if they had any of the following conditions within the previous six months: acute cardiac event, stroke, cancer, alcohol or substance abuse, hepatitis (B or C) or HIV, liver or renal dysfunction, history of dizziness/fainting during and after blood draws, lactose intolerance, gluten sensitivity or celiac disease. Excessive drinking, allergy or sensitivity to berries, pregnancy/lactation and smoking were also considered exclusion criteria. Eligible subjects were contacted to participate in a familiarization session in which detailed information of the study along with the consent form were presented. The use of medication as exclusion criteria was modified halfway throughout the study to increase recruitment. Each participant provided a written consent form before any study procedure was performed. Screening visits were scheduled to collect anthropometric (weight, height, BMI, and waist circumference) and physiological measurements (blood pressure, heart rate and oxygen saturation). During screening visits, participants also completed a voluntary demographic questionnaire. After completion of a 2-week run-in period, in which participants were given instructions to refrain from intake of polyphenol-rich foods and nutritional supplements, allocation to cherry or placebo groups was based on covariate adaptive randomization. This randomization method minimizes the imbalance between groups by considering specific covariates and previous assignments of participants [