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

NCT05229770 | Completed

• 1 other identifier: 155386/REK-A
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance-Related Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Biochemical indicator of inflammation

  Mid of the intervention period 16 weeks after initiation

• Biochemical indicators of fruit intake

  Mid of the intervention period 16 weeks after initiation

• Fatigue Symptom Scale

  Mid of the intervention period 16 weeks after initiation

• Physical functioning

  Mid of the intervention period 16 weeks after initiation

• Health-related quality of life

  Mid of the intervention period 16 weeks after initiation

Study Arms (2)

Fruit smoothie

EXPERIMENTAL

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

Standard

NO INTERVENTION

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

Interventions

Fruit smoothie DIETARY_SUPPLEMENT

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.

Fruit smoothie

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergies or prior anaphylactic reactions involving fruits or vegetables
• Poorly regulated diabetes type 1 or 2 (HbA1c \>60 mmol/mol)

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Stavanger HF: collaborator
• Helse Vest: collaborator
• University of Bergen: collaborator
• University of Oslo: collaborator

Study Sites (2)

LAR Helse Stavanger HF

Stavanger, Rogaland, 4010, Norway

Location

Department of Addiction Medicine, Haukeland University Hospital

Bergen, Vestland, 5020, Norway

Location

Related Publications (2)

• Javadi Arjmand E, Thomassen LM, Druckrey-Fiskaaen KT, Furulund E, Vold JH, Madebo T, Blomhoff R, Daltveit JT, Henriksen HB, Chalabianloo F, Johansen KA, Lid TG, Fadnes LT; ATLAS4LAR study group. The effect of fruit smoothie supplementation on psychological distress and biomarkers among people with opioid dependence receiving opioid agonist therapy: a randomized controlled trial. BMC Med. 2025 Aug 29;23(1):505. doi: 10.1186/s12916-025-04347-w.

  PMID: 40877839 DERIVED

• 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.

  PMID: 36057629 DERIVED

Related Links

• Description of ATLAS4LAR

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lars Fadnes, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: January 24, 2022
• First Posted: February 8, 2022
• Study Start: April 7, 2022
• Primary Completion: October 1, 2023
• Study Completion: March 15, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)