NCT05229770: FruktBAR

Effect of Fruit Smoothie Supplementation on Psychological Distress Among People Receiving Opioid Agonist Therapy

Completed NA Last updated 8 August 2025

What this trial tests

NA trial testing Fruit smoothie in Substance-Related Disorders in 324 participants. Completed in 15 March 2025.

Timeline

7 April 2022

Primary endpoint
1 October 2023

15 March 2025

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	324
Start date	7 April 2022
Primary completion	1 October 2023
Estimated completion	15 March 2025
Sites	2 locations across Norway

Drugs / interventions tested

• Fruit smoothie

Conditions studied

• Substance-Related Disorders — all drugs for Substance-Related Disorders →

Sponsor

Haukeland University Hospital

Who can join

18 and older, any sex, with Substance-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: People with substance use disorders generally have poor diets including limited intake of fruit and vegetables. Evidence shows substantial health benefits from increasing fruit and vegetable consumption on a variety of indicators and possibly also psychological distress. A pilot study has indicated that supplementation with fruit smoothie could be promising also among people receiving opioid agonist therapy (OAT) for opioid dependence. FruktBAR will compare the efficacy of fruit smoothie supplementation within the OAT clinics compared to standard treatment.

Study design: FruktBAR is a multicentre, randomised controlled trial. The trial will recruit approximately 230 patients receiving OAT in Bergen and Stavanger, Norway.

Intervention: The intervention involves daily supplementation with 250 ml fruit smoothie. The main endpoints are 16 weeks after intervention initiation. Participants will be included and followed up during and after intervention.

Study population: The target group will be patients with opioid dependence receiving OAT from involved outpatient clinics in Bergen and Stavanger.

Expected outcome: This study will inform on the relative advantages or disadvantages of a fruit supplementation in addition to the current medically and psychologically oriented treatment of people receiving opioid agonist therapy. If the supplementation is found to be safe and efficacious, it can be considered for further scale-up.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of fruit smoothie supplementation on psychological distress among people with substance use disorders receiving opioid agonist therapy: protocol for a randomised controlled trial (FruktBAR).
   Fadnes LT, Furulund E, Druckrey-Fiskaaen KT, Madebo T, et al · · 2022 · cited 2× · PMID 36057629 · DOI 10.1186/s40795-022-00582-z
2. The effect of fruit smoothie supplementation on psychological distress and biomarkers among people with opioid dependence receiving opioid agonist therapy: a randomized controlled trial.
   Javadi Arjmand E, Thomassen LM, Druckrey-Fiskaaen KT, Furulund E, et al · · 2025 · PMID 40877839 · DOI 10.1186/s12916-025-04347-w
3. Update of statistical analysis plan for: Effect of fruit smoothie supplementation on psychological distress among people with substance use disorders receiving opioid agonist therapy: protocol for a randomised controlled trial (FruktBAR)
   Arjmand EJ, Druckrey-Fiskaaen KT, Furulund E, Vold JH, et al · · 2024 · DOI 10.21203/rs.3.rs-4748489/v1