2.6. Study Procedure
ADVERSE EVENTS
This work was performed at the Institute of Nutrition, Mahidol University. Participants who passed the screening were randomly assigned into one of two groups. Each participant consumed the assigned product, a sachet of 14 g/day, twice daily before breakfast and before bed (for a total of 28 g/day) for 12 weeks. The sachets of both the coffee cherry pulp juice concentrate and the placebo are ready-to-eat. All participants were asked to consume the products directly from the sachets by using the provided disposable straws. They were instructed to record their daily consumption of the assigned products in their subject diaries. Additionally, they kept weekly diet records for three days per week (two weekdays and one weekend day) to describe other food they consumed throughout the study. The investigator checked the records in every follow-up visit to ensure the consistency of their consumption pattern. All participants were asked to maintain their usual physical activities throughout the study.During the consumption period, participants were instructed to follow up every 4 weeks. Follow-up was also conducted 2 weeks after stopping the intervention to assess safety. Signs of adverse events were measured using a blood test, urinalysis, body weight, vital signs, and electrocardiogram (EKG) at baseline (week 0) and at weeks 4, 8, 12, and 14 (2 weeks after stopping the intervention). Symptoms of adverse events were monitored daily by self-records in subject diaries and interviews by a researcher at the follow-up visits. The conceptual framework is shown in 