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

Haukeland University Hospital

Status: Completed

Conditions: Substance-Related Disorders

Treatments: Dietary Supplement: Fruit smoothie

Study type: Interventional

Funder types: Other

Identifiers

NCT05229770

155386/REK-A

Details and patient eligibility

About

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.

Full description

See below each section

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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324 participants in 2 patient groups

Fruit smoothie

Experimental group

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.

Treatment:

Dietary Supplement: Fruit smoothie

Standard

No Intervention group

Description:

Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation.