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

Substance-Related Disorders Clinical Trial

— FruktBAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05229770
• Other study ID #: 155386/REK-A
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See below each section

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 324
• Est. completion date: December 2026
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Dietary Supplement:
• Fruit 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.

Locations

Country	Name	City	State
Norway	Department of Addiction Medicine, Haukeland University Hospital	Bergen	Vestland
Norway	LAR Helse Stavanger HF	Stavanger	Rogaland

Sponsors (6)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF, Helse Vest, ProLAR Nett, University of Bergen, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biochemical indicator of inflammation	Biochemical indicators of inflammation measured with C-reactive protein in serum	Mid of the intervention period 16 weeks after initiation
Secondary	Biochemical indicators of fruit intake	Biochemical indicators of fruit intake measured with serum carotenoids	Mid of the intervention period 16 weeks after initiation
Secondary	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
Secondary	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
Secondary	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

External Links

•   Description of ATLAS4LAR