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

Sponsor

Haukeland University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05229770

Collaborator

Helse Stavanger HF (Other), Helse Vest (Other), University of Bergen (Other), ProLAR Nett (Other), University of Oslo (Other)

228

Enrollment

Locations

Arms

55.8

Anticipated Duration (Months)

114

Patients Per Site

Patients Per Site Per Month

Study Details

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	N/A

Detailed Description

See below each section

Study Design

Study Type:

Interventional

Anticipated Enrollment :

228 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.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 :

Apr 7, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 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.

Arm

Intervention/Treatment

Experimental: Fruit smoothie

Dietary Supplement: Fruit smoothie

No Intervention: Standard

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

Outcome Measures

Primary Outcome Measures

Psychological distress [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

Biochemical indicator of inflammation [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 [Mid of the intervention period 16 weeks after initiation]
Biochemical indicators of fruit intake measured with serum carotenoids
Fatigue Symptom Scale [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 [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 [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	LAR Helse Stavanger HF	Stavanger	Rogaland	Norway	4010
2	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Description of ATLAS4LAR

Publications

None provided.

Responsible Party:

Haukeland University Hospital

ClinicalTrials.gov Identifier:

NCT05229770

Other Study ID Numbers:

155386/REK-A

First Posted:

Feb 8, 2022

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haukeland University Hospital

Fruit

Food Supplementations

Opiate Substitution Treatment

Substance-Related Disorders

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Aug 9, 2022