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

Tracking Information

• First Submitted Date: January 24, 2022
• First Posted Date: February 8, 2022
• Last Update Posted Date: October 17, 2023
• Actual Study Start Date: April 7, 2022
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 7, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 7, 2022)

• 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
• 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
• 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)
• 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
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: 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.

Study Arms

• 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.
  Intervention: Dietary Supplement: Fruit smoothie
• No Intervention: Standard
  Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 16, 2023): 324
• Original Estimated Enrollment (submitted: February 7, 2022): 228
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT05229770
• Other Study ID Numbers: 155386/REK-A
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Haukeland University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Haukeland University Hospital
• Original Study Sponsor: Same as current

Collaborators

• Helse Stavanger HF
• Helse Vest
• University of Bergen
• ProLAR Nett
• University of Oslo

Investigators

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

• PRS Account: Haukeland University Hospital
• Verification Date: October 2023