Substance-Related DisordersFruktBARNCT05229770
Effect of Fruit Smoothie Supplementation on Psychological Distress Among People Receiving Opioid Agonist Therapy
A study testing Fruit smoothie in people with Substance-Related Disorders, run by Haukeland University Hospital at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Fruit smoothie
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 2 sitesNorway
- Study dates
- 7 Apr 2022to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergies or prior anaphylactic reactions involving fruits or vegetables
- Poorly regulated diabetes type 1 or 2 (HbA1c >60 mmol/mol)
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Addiction Medicine, Haukeland University Hospital
Bergen, Vestland, 5020
LAR Helse Stavanger HF
Stavanger, Rogaland, 4010
About this study
Official title: Effect of Fruit Smoothie Supplementation on Psychological Distress Among People With Substance Use Disorders Receiving Opioid Agonist Therapy: a Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
See below each section
- Conditions
- Substance-Related Disorders
- Being tested
- Fruit smoothie
- Keywords
- Fruit, Food Supplementations, Opiate Substitution Treatment, Substance-Related Disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit smoothieDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Fruit smoothie |
| Standard | No intervention | Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Mid of the intervention period 16 weeks after initiation
Secondary outcomes (5)
Biochemical indicator of inflammation
Biochemical indicators of inflammation measured with C-reactive protein in serum
Measured: Mid of the intervention period 16 weeks after initiation
Biochemical indicators of fruit intake
Biochemical indicators of fruit intake measured with serum carotenoids
Measured: Mid of the intervention period 16 weeks after initiation
Fatigue Symptom Scale
Changes in fatigue will be assessed with the Fatigue Symptom Scale (FSS-3, scale 0-18, higher values is worse)
Measured: Mid of the intervention period 16 weeks after initiation
Physical functioning
Physical functioning assessed with 4-minute step-test measuring number of steps climbed in period
Measured: Mid of the intervention period 16 weeks after initiation
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)
Measured: Mid of the intervention period 16 weeks after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start7 Apr 2022
- Primary completion1 Oct 2023
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, Helse Vest, University of Bergen, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Lars Fadnes, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229770
- Sponsor's protocol ID
- 155386/REK-A
- Acronym
- FruktBAR
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40877839Fadnes 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.
PubMed 36057629
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fruit Smoothie Supplementation on Psychological Distress Among People With Substance Use Disorders Receiving Opioid Agonist Therapy: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05229770
- Acronym / sponsor ID
- FruktBAR / 155386/REK-A
- Conditions
- Substance-Related Disorders
- Keywords
- Fruit, Food Supplementations, Opiate Substitution Treatment, Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, Helse Vest, University of Bergen, University of Oslo
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fruit smoothie | Experimental | Dietary Supplement: Fruit smoothieParticipants 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. |
| Standard | No intervention | –Participants randomised to standard treatment will receive regular OAT clinic follow-up without added supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Allergies or prior anaphylactic reactions involving fruits or vegetables
- Poorly regulated diabetes type 1 or 2 (HbA1c >60 mmol/mol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit smoothieParticipants 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 |
Primary outcome
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.
5 secondary outcomes
Biochemical indicator of inflammation
Time frame: Mid of the intervention period 16 weeks after initiation
Biochemical indicators of fruit intake
Time frame: Mid of the intervention period 16 weeks after initiation
Fatigue Symptom Scale
Time frame: Mid of the intervention period 16 weeks after initiation
Physical functioning
Time frame: Mid of the intervention period 16 weeks after initiation
Health-related quality of life
Time frame: Mid of the intervention period 16 weeks after initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 40877839Javadi 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.
- Derived from this study: PubMed 36057629Fadnes 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.
- Description of ATLAS4LARLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Fadnes, PhD principal investigator
Haukeland University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit smoothie in people with Substance-Related Disorders, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: Mid of the intervention period 16 weeks after initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05229770, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.