Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults

NCT ID: NCT04731454

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2020-10-02

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.

Conditions

Depression; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Healthy Nordic Diet (ND)

A healthy diet meeting and exceeding the Nordic Nutrition Recommendations and with more than 80% foods from the Nordic region.

Group Type: EXPERIMENTAL

Healthy Nordic Diet (ND)

Intervention Type: 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.

Control Diet (CD)

A control diet approximating the average depressed person's diet, i.e. of somewhat lower quality than the average Swedish diet.

Group Type: EXPERIMENTAL

Control Diet (CD)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia A Sabet, PhD

Role: STUDY_DIRECTOR

Örebro University, Sweden

Locations

Örebro University

Örebro, Närke, Sweden

Countries

Sweden

Other Identifiers

2020-03735

Identifier Type: -

Identifier Source: org_study_id