DepressionNCT04731454
Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults
A study testing Healthy Nordic Diet (ND) in people with Depression and Major Depressive Disorder, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Major Depressive Disorder
- What is being tested?
- Healthy Nordic Diet (ND)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2020to 2 Oct 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- If depressed, a score between 13 and 34 on the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S), indicating mild or moderate depression
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: a Randomized Controlled Pilot Trial
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.
Read the 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.
- Conditions
- Depression, Major Depressive Disorder
- Being tested
- Control Diet (CD), Healthy Nordic Diet (ND)
- Keywords
- Depression, Major Depressive Disorder, Diet, Nutrition, Randomized controlled trial, Pilot study, Healthy Nordic diet
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Diet (CD)Other
All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. A sugar-sweetened juice drink was provided for consumption of one portion per day. Water, milk, coffee, tea and alcohol were consumed as usual.
Healthy Nordic Diet (ND)Other
All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. Water, milk, coffee, tea and alcohol were consumed as usual.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Nordic Diet (ND) | Experimental | A healthy diet meeting and exceeding the Nordic Nutrition Recommendations and with more than 80% foods from the Nordic region. Receives: Other: Healthy Nordic Diet (ND) |
| Control Diet (CD) | Experimental | A control diet approximating the average depressed person's diet, i.e. of somewhat lower quality than the average Swedish diet. Receives: Other: Control Diet (CD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale)
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Measured: 8 days
Median rating of the appearance of all meals as assessed by an original Likert item
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Measured: 8 days
Median rating of the smell of all meals as assessed by an original Likert item
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Measured: 8 days
Median rating of the extent to which the smell matches the appearance of the meals as assessed by an original Likert item
1=Doesn't match at all, and 5=Matches very well. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Measured: 8 days
Median rating of the taste intensity of all meals as assessed by a Just About Right (JAR) scale
1=Much too low, 3=Just right, and 5=Much too high. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Measured: 8 days
Median rating of the portion size of all meals as assessed by a Just About Right (JAR) scale
1=Much too small, 4=Just right, and 7=Much too big. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Measured: 8 days
Median rating of feelings of fullness after the meals as assessed by an original visual analog scale (VAS)
0=Not at all full, and 100=Have never felt so full. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Measured: 8 days
Median perception of healthiness of all meals as assessed by an original visual analog scale (VAS)
0=Not at all healthy, and 100=Very healthy. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Measured: 8 days
Total amount of non-study foods consumed as assessed by self-report on a questionnaire every evening
Measured: 8 days
Total amount of non-study drinks consumed as assessed by self-report on a questionnaire every evening
Measured: 8 days
Total amount of provided juice drink not consumed as assessed by self-report on a questionnaire every evening.
Applies to the CD group only.
Measured: 8 days
Rating of how easy it was to follow the protocol, as assessed by an original Likert item on the final questionnaire
1=It was very hard, and 7=It was very easy
Measured: 8 days
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)
Assessed by an original Likert item on the final questionnaire where 1=It would be very hard, and 7=It would be very easy
Measured: 8 days
Secondary outcomes (10)
Change in work impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Expressed as percentage impairment, from 0-100%, where higher values indicate greater impairment in work ability
Measured: 8 days
Change in activity impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Expressed as percentage impairment, from 0-100%, where higher values indicate greater impairment in ability to perform daily activities.
Measured: 8 days
Change in gastrointestinal symptom severity after 8 days, as assessed by the total mean score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
1=no symptoms, 7=very severe symptoms
Measured: 8 days
Change in indigestion symptom severity after 8 days, as assessed by the indigestion sub-score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
1=no symptoms, 7=very severe symptoms
Measured: 8 days
Change in physical activity level after 8 days, as assessed by the Frändin-Grimby Physical Activity Scale
Score of 1-6, from least to most active
Measured: 8 days
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
Score of 0-54, from least to most severe symptoms
Measured: 8 days
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
0=Worst health imaginable, 100=Best health imaginable
Measured: 8 days
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
0=health as bad as dead, 1=full health
Measured: 8 days
Self-reported change in health after 8 days, as assessed by a written open-ended response on the final questionnaire
Due to the open-ended, self-reported nature of the responses, they are summarized narratively rather than quantitatively.
Measured: 8 days
Change in body weight after 8 days, as assessed by self-measurement or approximation
Change between self-reported baseline and follow-up body weights calculated.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start15 Sep 2020
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia A Sabet, PhD, Study director, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731454
- Sponsor's protocol ID
- 2020-03735
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04731454
- Acronym / sponsor ID
- 2020-03735
- Conditions
- Depression, Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder, Diet, Nutrition, Randomized controlled trial, Pilot study, Healthy Nordic diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 1 Feb 2021 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Nordic Diet (ND) | Experimental | Other: Healthy Nordic Diet (ND)A healthy diet meeting and exceeding the Nordic Nutrition Recommendations and with more than 80% foods from the Nordic region. |
| Control Diet (CD) | Experimental | Other: Control Diet (CD)A control diet approximating the average depressed person's diet, i.e. of somewhat lower quality than the average Swedish diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- If depressed, a score between 13 and 34 on the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S), indicating mild or moderate depression
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Control Diet (CD)All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. A sugar-sweetened juice drink was provided for consumption of one portion per day. Water, milk, coffee, tea and alcohol were consumed as usual. | Other | Control Diet (CD) |
| Healthy Nordic Diet (ND)All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. Water, milk, coffee, tea and alcohol were consumed as usual. | Other | Healthy Nordic Diet (ND) |
Primary outcome
Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale)
Time frame: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the appearance of all meals as assessed by an original Likert item
Time frame: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the smell of all meals as assessed by an original Likert item
Time frame: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the extent to which the smell matches the appearance of the meals as assessed by an original Likert item
Time frame: 8 days
1=Doesn't match at all, and 5=Matches very well. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the taste intensity of all meals as assessed by a Just About Right (JAR) scale
Time frame: 8 days
1=Much too low, 3=Just right, and 5=Much too high. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the portion size of all meals as assessed by a Just About Right (JAR) scale
Time frame: 8 days
1=Much too small, 4=Just right, and 7=Much too big. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of feelings of fullness after the meals as assessed by an original visual analog scale (VAS)
Time frame: 8 days
0=Not at all full, and 100=Have never felt so full. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median perception of healthiness of all meals as assessed by an original visual analog scale (VAS)
Time frame: 8 days
0=Not at all healthy, and 100=Very healthy. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Total amount of non-study foods consumed as assessed by self-report on a questionnaire every evening
Time frame: 8 days
Total amount of non-study drinks consumed as assessed by self-report on a questionnaire every evening
Time frame: 8 days
Total amount of provided juice drink not consumed as assessed by self-report on a questionnaire every evening.
Time frame: 8 days
Applies to the CD group only.
Rating of how easy it was to follow the protocol, as assessed by an original Likert item on the final questionnaire
Time frame: 8 days
1=It was very hard, and 7=It was very easy
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)
Time frame: 8 days
Assessed by an original Likert item on the final questionnaire where 1=It would be very hard, and 7=It would be very easy
10 secondary outcomes
Change in work impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Time frame: 8 days
Change in activity impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire
Time frame: 8 days
Change in gastrointestinal symptom severity after 8 days, as assessed by the total mean score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
Time frame: 8 days
Change in indigestion symptom severity after 8 days, as assessed by the indigestion sub-score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire
Time frame: 8 days
Change in physical activity level after 8 days, as assessed by the Frändin-Grimby Physical Activity Scale
Time frame: 8 days
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
Time frame: 8 days
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
Time frame: 8 days
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
Time frame: 8 days
Self-reported change in health after 8 days, as assessed by a written open-ended response on the final questionnaire
Time frame: 8 days
Change in body weight after 8 days, as assessed by self-measurement or approximation
Time frame: 8 days
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 1 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Julia A Sabet, PhD study director
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Nordic Diet (ND) in people with Depression and Major Depressive Disorder, run by Örebro University, Sweden at 1 site in Sweden.
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 1 inclusion and 4 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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale) (time frame: 8 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2021.