Clinical trial NCT04731454: Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults
Official title: Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
Diet
Nutrition
Randomized controlled trial
Pilot study
Healthy Nordic diet
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the future, we plan to conduct an 8-week diet intervention to investigate whether a healthy Nordic diet improves depression symptoms. The present pilot study tested whether the planned meals and diets were well-liked and accepted by participants (both depressed and non-depressed) in order to ensure that the future diet intervention will be feasible and successful. We also investigated whether any changes in health occurred after 8 days of this diet intervention.

Detailed description: After providing their written informed consent, participants were randomized to receive either a healthy Nordic diet or a control diet for 8 days. All meals were provided and minimal food preparation was required. Participants picked up their food outside the study kitchen every 3 days. Before and after the intervention, health-related self-rated questionnaires were completed. For every meal during the intervention, participants completed a questionnaire on their perceptions of the meal. Every evening a questionnaire was completed to assess dietary adherence. At the end of the study, a final evaluation questionnaire was completed to assess participants' perceptions of the diet and study as a whole.

Eligibility criteria: Inclusion Criteria:

* If depressed, a score between 13 and 34 on the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S), indicating mild or moderate depression

Exclusion Criteria:

* A score of 8 or higher (out of a maximum of 12 points) on a brief diet survey (the retired version of the Swedish Food Agency's online Matvanekollen, conducted via phone interview), indicating a relatively healthy habitual diet
* Presence of food allergies, intolerances or sensitivities
* Consuming any form of special diet that excludes certain foods, for example a vegetarian or gluten-free diet
* Suicidality, indicated by a score of 4 or higher on the MADRS-S suicidality question.

Primary outcomes:
measure: Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale)
timeFrame: 8 days
measure: Median rating of the appearance of all meals as assessed by an original Likert item
timeFrame: 8 days
measure: Median rating of the smell of all meals as assessed by an original Likert item
timeFrame: 8 days
measure: Median rating of the extent to which the smell matches the appearance of the meals as assessed by an original Likert item
timeFrame: 8 days
measure: Median rating of the taste intensity of all meals as assessed by a Just About Right (JAR) scale
timeFrame: 8 days
measure: Median rating of the portion size of all meals as assessed by a Just About Right (JAR) scale
timeFrame: 8 days
measure: Median rating of feelings of fullness after the meals as assessed by an original visual analog scale (VAS)
timeFrame: 8 days
measure: Median perception of healthiness of all meals as assessed by an original visual analog scale (VAS)
timeFrame: 8 days
measure: Total amount of non-study foods consumed as assessed by self-report on a questionnaire every evening
timeFrame: 8 days
measure: Total amount of non-study drinks consumed as assessed by self-report on a questionnaire every evening
timeFrame: 8 days
measure: Total amount of provided juice drink not consumed as assessed by self-report on a questionnaire every evening.
timeFrame: 8 days
measure: Rating of how easy it was to follow the protocol, as assessed by an original Likert item on the final questionnaire
timeFrame: 8 days
measure: Rating of how easy it would be to participate in such a study, with meals recurring every 8 days for 8 weeks (but not having to fill out a questionnaire for the meals)
timeFrame: 8 days
Secondary outcomes:
measure: Change in work impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: 8 days
measure: Change in activity impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: 8 days
measure: Change in gastrointestinal symptom severity after 8 days, as assessed by the total mean score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
timeFrame: 8 days
measure: Change in indigestion symptom severity after 8 days, as assessed by the indigestion sub-score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
timeFrame: 8 days
measure: Change in physical activity level after 8 days, as assessed by the Frändin-Grimby Physical Activity Scale
timeFrame: 8 days
measure: Change in depression severity after 8 days, as assessed by the total score of the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S) questionnaire
timeFrame: 8 days
measure: Change in perceived general health status after 8 days, as assessed by the visual analog scale (VAS) question of the EuroQol Health-Related Quality of Life (EQ-5D-5L) questionnaire
timeFrame: 8 days
measure: Change in general health after 8 days, as assessed by the summary index value calculated from the questions of the EuroQol Health-Related Quality of Life (EQ-5D-5L) questionnaire
timeFrame: 8 days
measure: Self-reported change in health after 8 days, as assessed by a written open-ended response on the final questionnaire
timeFrame: 8 days
measure: Change in body weight after 8 days, as assessed by self-measurement or approximation
timeFrame: 8 days
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
state: Närke
Study officials:
affiliation: Örebro University, Sweden
name: Julia A Sabet, PhD
role: STUDY_DIRECTOR
References: