Substance-Related Disorders
Conditions
Keywords
Fruit, Food Supplementations, Opiate Substitution Treatment, Substance-Related Disorders
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
Interventions
DIETARY_SUPPLEMENTFruit smoothie
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.
Sponsors
Helse Stavanger HF
Helse Vest
University of Bergen
University of Oslo
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Even though complete blinding is regarded as difficult and infeasible, patients will be informed of the follow-up they will receive but not on other follow-up alternatives that are used or the exact hypotheses for the study. Outcomes assessor will be blinded.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Biochemical indicator of inflammation | Mid of the intervention period 16 weeks after initiation | Biochemical indicators of inflammation measured with C-reactive protein in serum |
| 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) |
| 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) |
Countries
Norway
Outcome results
None listed