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Background <p>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.</p> Methods <p>In this multicenter randomized controlled trial (FruktBAR), 311 participants receiving OAT were randomized (5:3 intervention:control) to receive either a daily 250&#xa0;ml fruit smoothie for 16&#xa0;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.</p> Results <p>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).&#xa0;</p> Conclusions <p>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.&#xa0;</p> Trial registration <p>ClinicalTrials.gov&#xa0;NCT05229770. Registered on 08 February 2022.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月29日

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  • Elaheh Javadi Arjmand,
  • Lise Margrete Thomassen,
  • Karl Trygve Druckrey-Fiskaaen,
  • Einar Furulund,
  • Jørn Henrik Vold,
  • Tesfaye Madebo,
  • Rune Blomhoff,
  • Jan Tore Daltveit,
  • Hege Berg Henriksen,
  • Fatemeh Chalabianloo,
  • Kjell Arne Johansen,
  • Torgeir Gilje Lid,
  • Lars Thore Fadnes,
  • Vibeke Bråthen Buljovcic,
  • Siv-Elin Leirvåg Carlsen,
  • Jan Tore Daltveit,
  • Tine Berger Edvardsdal,
  • Karl Trygve Druckrey-Fiskaaen,
  • Lars T. Fadnes,
  • Trude Fondenes,
  • Per Gundersen,
  • Anne Eriksen Hammer,
  • Else-Marie Løberg,
  • Mette Hegland Nordbotn,
  • Maria Olsvold,
  • Marianne Cook Pierron,
  • Kristin Sannerud,
  • Christine Sundal,
  • Beate Haga Trettenes,
  • Jørn-Henrik Vold,
  • Maren Borsheim Bergsaker,
  • Tine Selmer Cruickshank,
  • Eivin Dahl,
  • Tone Lise Eielsen,
  • Torhild Fiskå,
  • Einar Furulund,
  • Eirik Holder,
  • Torgeir Gilje Lid,
  • Tesfaye Madebo,
  • Mari Soot,
  • Rune Blomhoff,
  • Hege Berg Henriksen

摘要

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.