Effect of Fruit Smoothie Supplementation on Psychological Distress Among People Receiving Opioid Agonist Therapy
- Conditions
- Substance-Related Disorders
- Registration Number
- NCT05229770
- Lead Sponsor
- Haukeland University Hospital
- Brief Summary
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.
- Detailed Description
See below each section
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
- 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
- Allergies or prior anaphylactic reactions involving fruits or vegetables
- Poorly regulated diabetes type 1 or 2 (HbA1c >60 mmol/mol)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Psychological distress 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 Outcome Measures
Name Time Method Biochemical indicators of fruit intake Mid of the intervention period 16 weeks after initiation Biochemical indicators of fruit intake measured with serum carotenoids
Fatigue Symptom Scale 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)
Biochemical indicator of inflammation Mid of the intervention period 16 weeks after initiation Biochemical indicators of inflammation measured with C-reactive protein in serum
Physical functioning Mid of the intervention period 16 weeks after initiation Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period
Health-related quality of life 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)
Trial Locations
- Locations (2)
LAR Helse Stavanger HF
🇳🇴Stavanger, Rogaland, Norway
Department of Addiction Medicine, Haukeland University Hospital
🇳🇴Bergen, Vestland, Norway
LAR Helse Stavanger HF🇳🇴Stavanger, Rogaland, Norway