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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a personalized nutrition plan might improve mood in children and adolescents diagnosed with depression. Researchers believe that a healthy diet, rich in fruits, vegetables, nuts, and lean meats, could positively impact mental health. Participants will receive either guidance based on Canada’s food guide or a tailored nutrition plan. Young people with depression, regular internet access, and a supportive parent ready to participate would be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of nutrition on mental health.

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 prior data suggests that this personalized nutrition plan is safe for adolescents with depression?

Research has shown that personalized nutrition plans positively impact mental health. One study found that a tailored diet reduced symptoms of depression and improved the quality of life for older adults, suggesting these plans are generally easy to follow, with no reports of serious side effects.

Another study compared a personalized diet plan with general dietary advice, focusing on heart and blood vessel health. It found no major safety issues, indicating that personalized nutrition plans are generally safe.

These findings suggest that personalized nutrition plans, like the one under study, are likely safe and easy to follow. There have been no reports of harmful side effects, making them a promising option for improving mood and overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about personalized nutrition plans for depression because they offer a tailored approach to managing the condition, unlike traditional treatments like antidepressants or therapy. This method focuses on customizing dietary recommendations based on an individual's specific nutritional needs and health profile, potentially addressing underlying nutritional deficiencies that might contribute to depressive symptoms. By personalizing the diet, this approach aims to optimize mental health outcomes more effectively and naturally, offering a promising alternative or complement to existing treatments.

What evidence suggests that this personalized nutrition plan might be an effective treatment for depression?

Research has shown that personalized nutrition plans can help reduce symptoms of depression. In one study, older adults experienced fewer depression symptoms and improved quality of life after following a tailored diet. Another study found that nutrition counseling reduced depression symptoms and enhanced work performance. Precision supplements, a component of personalized nutrition, significantly reduced depression symptoms in nearly 70% of participants in another study. In this trial, participants in the "Personalized Nutrition Plan and Support" arm will receive a tailored nutrition intervention. These findings suggest that a customized diet might be a promising way to support mental health in young people with depression. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10547149/

A personalized diet intervention improves depression ... The results demonstrated that the personalized dietary intervention reduced depression symptoms and improved the quality of life among older adults.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12423455/

Effectiveness of improving nutrition on depressive ... Summary: This study will provide evidence of the effectiveness of nutrition counselling on depressive symptoms and related sick leave days, work ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000134

Data in Personalized Nutrition: Bridging Biomedical ... This perspective proposes a comprehensive framework for Personalized Nutrition (PN) that integrates biomedical, psycho-behavioral, and environmental data

4. nature.com nature.com/articles/s41591-024-02951-6

Effects of a personalized nutrition program on ... We compared a personalized dietary program (PDP) versus general advice (control) on cardiometabolic health using a randomized clinical trial.

5. medrxiv.org medrxiv.org/content/10.1101/2023.04.18.23288750v1.full-text

The effectiveness of precision supplements on depression ... Thus, precision supplement use over ∼6 months significantly reduced depression symptoms, with 69.8% of the individuals in the intervention group ...

6. withpower.com withpower.com/trial/phase-depressive-disorder-major-2025-95677

Personalized Nutrition for Depression (MAKE-IT pRCT Trial) Research shows that nutrition interventions, including personalized plans, can have positive effects on mental health, with many studies reporting significant ...

7. cambridge.org cambridge.org/core/journals/british-journal-of-nutrition/article/personalised-nutrition-intervention-for-adolescent-depression-a-mixedmethods-feasibility-pilot-study/B63A2F914C208B7AE071298E8A940BE8

A personalised nutrition intervention for adolescent ... Randomised controlled trials have demonstrated the benefit of diet modification to improve diet quality in the treatment of adult major ...