Feasibility and acceptability of a beverage intervention for Hispanic adults: results from a pilot randomized controlled trial

Abstract

Objective To assess the feasibility and acceptability of a beverage intervention in Hispanic adults. Design Eligible individuals identified as Hispanic, were 18-64 years old and had BMI 30.0-50.0 kg/m(2). Participants were randomized 2:2:1 to one of three beverages: Mediterranean lemonade (ML), green tea (GT) or flavoured water control (FW). After a 2-week washout period, participants were asked to consume 32 oz (946 ml) of study beverage daily for 6 weeks and avoid other sources of tea, citrus, juice and sweetened beverages; water was permissible. Fasting blood samples were collected at baseline and 8 weeks to assess primary and secondary efficacy outcomes. Setting Tucson, AZ, USA. Participants Fifty-two participants were recruited over 6 months; fifty were randomized (twenty-one ML, nineteen GT, ten FW). Study population mean (sd) age 44.6 (sd 10.2) years, BMI 35.9 (4.6) kg/m(2); 78 % female. Results Forty-four (88 %) completed the 8-week assessment. Self-reported adherence was high. No significant change (95 % CI) in total cholesterol (mg/dl) from baseline was shown -1.7 (-14.2, 10.9), -3.9 (-17.2, 9.4) and -13.2 (-30.2, 3.8) for ML, GT and FW, respectively. Mean change in HDL-cholesterol (mg/dl) -2.3 (-5.3, 0.7; ML), -1.0 (-4.2, 2.2; GT), -3.9 (-8.0, 0.2; FW) and LDL-cholesterol (mg/dl) 0.2 (-11.3, 11.8; ML), 0.5 (-11.4, 12.4; GT), -9.8 (-25.0, 5.4; FW) were also non-significant. Fasting glucose (mg/dl) increased significantly by 5.2 (2.6, 7.9; ML) and 3.3 (0.58, 6.4; GT). No significant change in HbA1c was demonstrated. Due to the small sample size, potential confounders and effect modifiers were not investigated. Conclusions Recruitment and retention figures indicate that a larger-scale trial is feasible; however, favourable changes in cardiometabolic biomarkers were not demonstrated.