The effect of fruit smoothie supplementation on psychological distress and biomarkers among people with opioid dependence receiving opioid agonist therapy: a randomized controlled trial

Abstract

Background: Unhealthy diets are common among individuals with opioid dependence. While fruit- and vegetable-rich diets have shown mental health benefits, evidence is limited for those receiving opioid agonist therapy (OAT). This trial evaluated the effectiveness of fruit smoothie supplementation for people receiving OAT compared to standard treatment without fruit smoothie supplementation.

Methods: In this multicenter randomized controlled trial (FruktBAR), 311 participants receiving OAT were randomized (5:3 intervention:control) to receive either a daily 250 ml fruit smoothie for 16 weeks in addition to standard OAT or standard OAT alone. The primary outcome was the difference between the arms in changes in psychological distress, measured by the ten-item Hopkins Symptom Checklist (SCL-10%) from baseline to the end of the intervention. The secondary outcomes included changes in fatigue symptoms, measured using the three-item Fatigue Severity Scale, physical fitness, measured by a 4-min step test, carotenoid and folate biomarkers.

Results: At baseline, 131 participants (70%) in the intervention arm and 91 (73%) in the control arm had a low intake of fruits and vegetables. In the intervention arm, the mean SCL-10% score at baseline was 43.9% (95% confidence interval (CI): 40.4, 47.4), which was reduced to 41.6% (CI: 38.0, 5.1) at the end of the trial. In the control arm, the mean SCL-10% score was 43.6% at baseline (CI: 39.3, 48.0) and decreased to 41.5% (CI: 37.1, 45.8) at the end of the trial period. No significant difference in the change of psychological distress between the intervention and control arms was found (- 0.14%; CI: - 4.49, 2.22). Additionally, no changes were found between the intervention and control arms regarding fatigue symptoms, physical fitness, carotenoid, or folate biomarkers. The mean consumed fruit smoothies reported in the intervention arm was 3.9 bottles per week (SD 1.5). CONCLUSIONS: Fruit smoothie supplementation over a 16-week period did not impact psychological distress, fatigue, physical fitness, carotenoids, or folate biomarkers among people receiving OAT. Although the smoothies were successfully delivered to the participants, our data indicates suboptimal adherence to the intervention rather than the lack of efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05229770. Registered on 08 February 2022.

Keywords: Food supplementations; Fruit; Opioid agonist therapy; Psychological distress; Randomized controlled trial; Substance use disorder.

Fig. 1

CONSORT flow diagram for the trial participants

Fig. 2

Changes in the mean SCL-10% scores from baseline to the end of intervention in intervention and control groups (based on intention-to-treat analysis). EOI, end of intervention

Fig. 3

Forest plot of subgroup analysis. The difference between arms in changes in the percentage of mean SCL-10, stratified for age, sex, OAT medication, intake of fruits and vegetables, living alone, and substance use score. The changes in SCL-10% are estimated using linear mixed models

Fig. 4

The changes in median levels of biomarkers of fruit smoothie intake after the intervention. The ranges have been standardized by dividing each value by the largest estimate within that measurement. Total refers to total carotenoids. Folate: n = 311; carotenoids: n = 76