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

• ClinicalTrials.gov Identifier: NCT05229770
• Recruitment Status: Active, not recruiting
• First Posted: February 8, 2022
• Last Update Posted: October 17, 2023
• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF; Helse Vest; University of Bergen; ProLAR Nett; University of Oslo
• Information provided by (Responsible Party): Haukeland University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Substance-Related Disorders	Dietary Supplement: Fruit smoothie	Not Applicable

Detailed Description:

See below each section

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• 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.
• Primary Purpose: Treatment
• Official Title: Effect of Fruit Smoothie Supplementation on Psychological Distress Among People With Substance Use Disorders Receiving Opioid Agonist Therapy: a Randomised Controlled Trial
• Actual Study Start Date: April 7, 2022
• Estimated Primary Completion Date: October 2023
• Estimated Study Completion Date: December 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
No Intervention: Standard; Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation.

Outcome Measures

Primary Outcome Measures :

1. Psychological distress [ Time Frame: 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 Outcome Measures :

1. Biochemical indicator of inflammation [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
   Biochemical indicators of inflammation measured with C-reactive protein in serum
2. Biochemical indicators of fruit intake [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
   Biochemical indicators of fruit intake measured with serum carotenoids
3. Fatigue Symptom Scale [ Time Frame: 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)
4. Physical functioning [ Time Frame: Mid of the intervention period 16 weeks after initiation ]
   Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period
5. Health-related quality of life [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Norway

LAR Helse Stavanger HF

Stavanger, Rogaland, Norway, 4010

Department of Addiction Medicine, Haukeland University Hospital

Bergen, Vestland, Norway, 5020

Sponsors and Collaborators

Haukeland University Hospital

Helse Stavanger HF

Helse Vest

University of Bergen

ProLAR Nett

University of Oslo

Investigators

• Principal Investigator: Lars Fadnes, PhD; Haukeland University Hospital

More Information

Additional Information:

Description of ATLAS4LAR 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT05229770
• Other Study ID Numbers: 155386/REK-A
• First Posted: February 8, 2022
• Last Update Posted: October 17, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:

Fruit; Food Supplementations; Opiate Substitution Treatment; Substance-Related Disorders

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders