Personalized Nutrition for Depression

(MAKE-IT pRCT Trial)

Overseen By Daphne J Korczak, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Eating disorder, Chronic condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dietary changes for depression.

What data supports the effectiveness of the treatment Personalized Nutrition Plan for depression?

Research shows that nutrition interventions, including personalized plans, can have positive effects on mental health, with many studies reporting significant improvements in depressive symptoms when essential nutrients like fatty acids, vitamins, or minerals are added to the diet. ^{1 2 3 4 5}

Is personalized nutrition safe for treating depression?

Personalized nutrition approaches, like those using omega-3 fatty acids, are generally considered safe, but potential side effects such as stomach and skin issues should be monitored. It's important to consult with a healthcare provider to ensure safety, especially for specific groups like pregnant women, children, and the elderly. ^{6 7 8 9 10}

How does the Personalized Nutrition Plan treatment for depression differ from other treatments?

The Personalized Nutrition Plan for depression is unique because it tailors dietary recommendations based on an individual's gut microbiota, aiming to maximize the benefits of diet on mental health. This approach is different from standard treatments as it focuses on diet's role in modulating gut bacteria, which is linked to depression, rather than relying solely on medication or therapy. ^{11 12 13 14 15}

What is the purpose of this trial?

This study is being done to examine the feasibility, including recruitment, retention and acceptability of a randomized controlled trial of a personalized dietary intervention in adolescents with depression. Evidence suggests that dietary quality may affect an individual's mood. A healthy diet includes vegetables, fruit, nuts, seeds, and olive oil, as well as minimally processed whole grains, legumes, and moderate amounts of lean meat, fish, and dairy. The investigators will examine the feasibility of testing a personalized nutrition eating plan in a study that uses a randomized controlled trial design for children and youth with depression.

Eligibility Criteria

The MAKE-It Pilot Trial is for adolescents with major depressive disorder (MDD) who have internet access and a device like a computer or smartphone. They need to have a parent willing to participate and score at least 25 on the CESD-C depression scale.

Inclusion Criteria

Center for Epidemiological Studies Depression Scale for Children (CESD-C) score ≥ 25 at baseline

Access to the internet and a computer or smart phone

Presence of a parent who is willing to participate

Exclusion Criteria

Currently participating in other dietary programs or studies

Adherent to a high-quality diet at baseline

Presence of an eating disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized dietary intervention or information about Canada's food guide

9 weeks

Baseline and follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Personalized Nutrition Plan

Trial Overview This trial tests whether a personalized nutrition plan can help improve mood in depressed adolescents. It's designed as a randomized controlled study, which means participants are randomly assigned to receive either the dietary intervention or not.

Participant Groups

Group I: Personalized Nutrition Plan and Support Experimental Treatment 1 Intervention

This group will receive the nutrition intervention

Group II: Control Active Control 1 Intervention

This group will receive information about Canada's food guide, a recommended healthy diet.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Findings from Research

Personalized nutrition (PN) can effectively promote dietary behavior changes and improve health outcomes, but a clear definition and guiding principles are necessary for its credibility and efficacy.

The article proposes a definition for PN and outlines 10 guiding principles to ensure responsible and evidence-based practices, highlighting the need for further research to address challenges in implementation and measurement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Guiding Principles for the Implementation of Personalized Nutrition Approaches That Benefit Health and Function. Adams, SH., Anthony, JC., Carvajal, R., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Dietary intake and depressive symptoms: a systematic review of observational studies. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Improved food intake and weight gain in adult patients following electroconvulsive therapy for depression. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of nutrient intake among depressed and nondepressed individuals. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Nutrition interventions in populations with mental health conditions: a scoping review. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring the Role of Nutraceuticals in Major Depressive Disorder (MDD): Rationale, State of the Art and Future Prospects. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Severity of depressive symptoms and accuracy of dietary reporting among obese women with major depressive disorder seeking weight loss treatment. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Perspective: Guiding Principles for the Implementation of Personalized Nutrition Approaches That Benefit Health and Function. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Coronary Health Improvement Project (CHIP) is associated with improved nutrient intake and decreased depression. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

International Society for Nutritional Psychiatry Research Practice Guidelines for Omega-3 Fatty Acids in the Treatment of Major Depressive Disorder. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Adequacy of the dietary intake of depressed individuals. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Nutrition for Depression: Impact on the Unholy Trinity. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Assessing the feasibility of an m-Health intervention for changing diet quality and mood in individuals with depression: the My Food & Mood program. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Dietary pattern and depressive symptoms in middle age. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Quantification of the Effect of Vitamin E Intake on Depressive Symptoms in United States Adults Using Restricted Cubic Splines. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Dietary recommendations for the prevention of depression. [2019]