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

Study Overview
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Brief Summary
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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
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See below each section

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

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Dietary Supplement: Fruit smoothie


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fruit smoothie<br>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. | Dietary Supplement: Fruit smoothie<br>* 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.<br>|
| No Intervention: Standard<br>Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological distress | 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. | Mid of the intervention period 16 weeks after initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical indicator of inflammation | Biochemical indicators of inflammation measured with C-reactive protein in serum | Mid of the intervention period 16 weeks after initiation | 
| Biochemical indicators of fruit intake | Biochemical indicators of fruit intake measured with serum carotenoids | Mid of the intervention period 16 weeks after initiation | 
| Fatigue Symptom Scale | Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3, scale 0-18, higher values is worse) | Mid of the intervention period 16 weeks after initiation | 
| Physical functioning | Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period | Mid of the intervention period 16 weeks after initiation | 
| Health-related quality of life | Changes in health-related quality of life will be assessed with EuroQoL EQ-5D-5L (0-100, higher is better) | Mid of the intervention period 16 weeks after initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fruit, Food Supplementations, Opiate Substitution Treatment, Substance-Related Disorders