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Completed

NCT Number: NCT05229770

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

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LAR Helse Stavanger HF, Stavanger, Rogaland, Norway

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About this study

See below each section

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receiving OAT from an included outpatient clinic with outpatient follow-up on weekly basis
  • Having fruit and vegetable intake below 3 portions per day (assessed at screening)
  • Confirming interest in participating in diet intervention (criteria specified)
  • Giving informed consent

Exclusion criteria

  • Allergies or prior anaphylactic reactions involving fruits or vegetables
  • Poorly regulated diabetes type 1 or 2 (HbA1c >60 mmol/mol)

Treatment and study plan

Fruit smoothie

Dietary Supplement

Participants randomised to the intervention arm will receive a 250 ml fruit smoothie as diet supplement for 20 weeks in addition to the regular OAT clinic follow-up. The fruit smoothies will be marketed products including combinations of the following fruits: apple, pineapple, mango, bananas, orange, blueberries, passion fruit, coconut, lime, and blackcurrant. The participants will receive a mixture of different smoothie types with the option of removing alternatives based on preferences. Fruit smoothie products will come in plastic bottles and will be delivered directly to the participants on a weekly basis. Each participant will receive a total of seven smoothie bottles per week with an oral agreement with each participant to consume one of these per day. Delivery of fruit smoothie will generally be given in parallel with delivery of OAT medication.

Primary outcomes

  1. Psychological distress

    Time frame: Mid of the intervention period 16 weeks after initiation

    The primary outcome is psychological distress assessed with the Norwegian validated translation ten item version of Hopkins Symptom Checklist (SCL-10) in the mid of the intervention period 16 weeks after initiation (12-20). This will be evaluated with mean SCL-10 item score and compared between intervention and control arm.

Secondary outcomes

  1. Biochemical indicator of inflammation

    Time frame: Mid of the intervention period 16 weeks after initiation

    Biochemical indicators of inflammation measured with C-reactive protein in serum

  2. Biochemical indicators of fruit intake

    Time frame: Mid of the intervention period 16 weeks after initiation

    Biochemical indicators of fruit intake measured with serum carotenoids

  3. Fatigue Symptom Scale

    Time frame: Mid of the intervention period 16 weeks after initiation

    Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3, scale 0-18, higher values is worse)

  4. Physical functioning

    Time frame: Mid of the intervention period 16 weeks after initiation

    Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period

  5. Health-related quality of life

    Time frame: Mid of the intervention period 16 weeks after initiation

    Changes in health-related quality of life will be assessed with EuroQoL EQ-5D-5L (0-100, higher is better)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Stavanger HF
  • Helse Vest
  • University of Bergen
  • University of Oslo

Registry information

Official study title

Effect of Fruit Smoothie Supplementation on Psychological Distress Among People With Substance Use Disorders Receiving Opioid Agonist Therapy: a Randomised Controlled Trial

Acronym: FruktBAR

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Feb 8, 2022
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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