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

Abstract

AbstractObjectiveTo assess the feasibility and acceptability of a beverage intervention in Hispanic adults.DesignEligible individuals identified as Hispanic, were 18–64 years old and had BMI 30·0–50·0 kg/m2. 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.SettingTucson, AZ, USA.ParticipantsFifty-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/m2; 78 % female.ResultsForty-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.ConclusionsRecruitment and retention figures indicate that a larger-scale trial is feasible; however, favourable changes in cardiometabolic biomarkers were not demonstrated.