Clinical trial NCT05229770: Effect of Fruit Smoothie Supplementation on Psychological Distress Among People Receiving Opioid Agonist Therapy
Official title: Effect of Fruit Smoothie Supplementation on Psychological Distress Among People With Substance Use Disorders Receiving Opioid Agonist Therapy: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Fruit
Food Supplementations
Opiate Substitution Treatment
Substance-Related Disorders
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: Helse Vest
name: University of Bergen
name: ProLAR Nett
name: University of Oslo
First posted: 2022-02-08
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Psychological distress
timeFrame: Mid of the intervention period 16 weeks after initiation
Secondary outcomes:
measure: Biochemical indicator of inflammation
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Biochemical indicators of fruit intake
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Fatigue Symptom Scale
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Physical functioning
timeFrame: Mid of the intervention period 16 weeks after initiation
measure: Health-related quality of life
timeFrame: Mid of the intervention period 16 weeks after initiation
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: LAR Helse Stavanger HF
state: Rogaland
city: Bergen
country: Norway
facility: Department of Addiction Medicine, Haukeland University Hospital
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Lars Fadnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fadnes LT, Furulund E, Druckrey-Fiskaaen KT, Madebo T, Vold JH, Olsvold M, Pierron MC, Carlsen SL, Blomhoff R, Lid TG; ATLAS4LAR Study Group. 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). BMC Nutr. 2022 Sep 3;8(1):97. doi: 10.1186/s40795-022-00582-z.