Diet Changes for Depression

Overseen By D. Nyasha Chagwedera, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Psychiatric hospitalization, Suicidal ideation, Severe mood state, GI problems, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether reducing ultra-processed foods can improve symptoms in people with major depressive disorder. Participants will follow different eating plans: one maintaining their usual diet and another significantly reducing processed foods. The trial suits those who consume many ultra-processed foods and are willing to continue their current mental health treatments during the study. Participants must also attend in-person visits at UCSF. As an unphased study, this trial provides a unique opportunity to contribute to understanding dietary impacts on mental health.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, you must not change your psychotropic medication or psychotherapy regimen during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming a lot of ultra-processed foods links to various health problems. Studies have found that people who eat more of these foods face a higher risk of developing issues like heart disease, obesity, and depression. For instance, one study found that individuals who consumed the most ultra-processed foods had a 31% higher risk of depression compared to those who ate the least.

This trial involves reducing the intake of ultra-processed foods. No medicine or new chemical is involved, so it is generally considered safe. Instead of adding something new to the diet, the focus is on reducing processed foods, which research suggests could lead to better health. Cutting down on ultra-processed foods might improve mood and overall well-being without adding extra risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about reducing ultra-processed foods for treating depression because it offers a non-pharmaceutical approach to mental health. Unlike standard treatments like antidepressants and therapy, which can take time to show results and may have side effects, dietary changes are a natural, accessible option that could lead to improvements in just a few weeks. This approach targets the underlying inflammation and gut health issues linked to depression, offering a holistic alternative that fits into everyday life.

What evidence suggests that reducing ultra-processed foods might be an effective treatment for depression?

This trial will compare the effects of dietary changes on depression by alternating between regular diets and diets low in ultra-processed foods (UPF). Research has shown that eating fewer UPF might reduce the risk of depression. Studies have found that people who cut down on UPF by at least three servings a day experienced fewer symptoms of depression. Other research discovered that consuming a lot of UPF could increase the chance of becoming depressed. A small study also suggests that people find it manageable to eat less UPF. Overall, reducing UPF intake might lead to a better mood and improved mental health. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrew Krystal, MD, MS

Principal Investigator

University of California, San Francisco

D. Nyasha Chagwedera, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with major depressive disorder who regularly consume a high amount of ultra-processed foods. It's designed to see if changing their diet can help with depression.

Inclusion Criteria

I can visit UCSF in person three times.

Ability to speak and read English and answer participant surveys

I eat enough to maintain a healthy weight.

Exclusion Criteria

Active suicidal ideation with intent and plan or scoring a 3 or higher on the Columbia suicide severity rating scale (C-SSRS)

In a current severe mood state when entering the study that would prohibit compliance with study visits or dietary program

Anticipating or planning any major changes in physical activity or sleep during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Regular diet phase

Participants eat their regular diet for 4 weeks

4 weeks

Intervention diet phase

Participants eat a diet low in ultra-processed foods for 4 weeks

4 weeks

Follow-up

Participants are monitored for acceptability and feasibility of the intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Reduction of Ultra-processed foods

Trial Overview

The study tests the effects of reducing ultra-processed foods from participants' diets in a personalized way, aiming to understand its impact on depression symptoms.

How Is the Trial Designed?

Group I: Regular diet then intervention diet Experimental Treatment 1 Intervention

4 weeks of eating the participant's regular diet followed by 4 weeks of eating a diet low in ultra-processed foods.

Group II: Intervention diet then regular diet Experimental Treatment 1 Intervention

4 weeks eating a diet low in ultra-processed foods in diet followed by 4 weeks of eating the participant's regular diet.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

In a study of 2572 Brazilian adults over an average follow-up of nearly 3 years, higher consumption of ultra-processed foods (UPF) was linked to an increased risk of developing depression, with those in the highest quartile of UPF intake having an 82% higher risk compared to those in the lowest quartile.

The average UPF consumption among participants was 44 g/day, accounting for 24% of their daily energy intake, suggesting that dietary choices may significantly impact mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed food consumption is positively associated with the incidence of depression in Brazilian adults (CUME project). Leal, ACG., Lopes, LJ., Rezende-Alves, K., et al.[2023]

Ultra-processed foods make up about 46% of daily energy intake in Germany and are linked to various non-communicable diseases such as obesity, diabetes, and cardiovascular disease.

The study highlights the need for intervention studies to better understand the mechanisms behind these associations and to improve dietary assessments in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What is ultra-processed food and how is it related to diet-related diseases?] Fedde, S., Rimbach, G., Schwarz, K., et al.[2022]

In a study of 26,730 participants over an average follow-up of 5.4 years, higher consumption of ultra-processed foods (UPF) was linked to an increased risk of developing depressive symptoms, with a hazard ratio of 1.21 for every 10% increase in UPF in the diet.

The association between UPF and depressive symptoms was particularly significant for beverages and sauces or added fats, highlighting the importance of considering dietary quality for mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective association between ultra-processed food consumption and incident depressive symptoms in the French NutriNet-Santé cohort. Adjibade, M., Julia, C., Allès, B., et al.[2020]

A systematic review of 28 observational studies found a positive association between the intake of ultra-processed foods (UPF) and the risk of depression, with 21 studies being cross-sectional and 6 cohort studies supporting this link.

The review highlights the need for future research to utilize validated food intake assessments and standardized methods for measuring depression to improve the comparability of findings across studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed food intake and risk of depression: a systematic review. Tian, YR., Deng, CY., Xie, HC., et al.[2023]

A study of 596 younger Italian adults found that those with the highest consumption of ultra-processed foods (UPFs) had significantly higher odds of experiencing depressive symptoms, with an odds ratio of 2.04 after adjusting for confounding factors.

The association between UPF consumption and depressive symptoms strengthened further when accounting for adherence to the Mediterranean diet, suggesting that diet quality may influence mental health outcomes and highlighting the need for more research into the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Food Consumption and Depressive Symptoms in a Mediterranean Cohort. Godos, J., Bonaccio, M., Al-Qahtani, WH., et al.[2023]

In a study of 4554 British participants, those with the highest intake of ultra-processed foods (UPF) had a 31% higher likelihood of experiencing recurrent depressive symptoms compared to those with lower UPF consumption.

The findings suggest that high UPF intake not only increases the risk of depression but also weakens the relationship between overall diet quality and depressive symptoms, indicating the importance of dietary choices in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between ultra-processed foods and recurrence of depressive symptoms: the Whitehall II cohort study. Arshad, H., Head, J., Jacka, FN., et al.[2023]

In a study of 183,474 participants over 13.1 years, higher consumption of ultra-processed foods (UPF) was linked to an increased risk of developing depression and anxiety, with hazard ratios indicating a significant association.

Participants in the highest quartile of UPF consumption had a 22% higher risk of depression and a 13% higher risk of anxiety compared to those in the lowest quartile, suggesting that diet may play a crucial role in mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of ultra-processed food consumption with incident depression and anxiety: a population-based cohort study. Sun, M., He, Q., Li, G., et al.[2023]

In a study of 3880 participants aged 40-69, those with high depressive symptoms and high consumption of ultra-processed foods (UPF) had a significantly increased risk of developing type 2 diabetes (T2D), with an adjusted hazard ratio of 1.58.

The combination of high depressive symptoms and antidepressant use with high UPF consumption also showed a similar risk for T2D (aHR 1.62), suggesting that addressing both mental health and dietary habits may be crucial for diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of ultra-processed food consumption and depression on type 2 diabetes incidence: a prospective community study in Quebec, Canada. Sen, A., Brazeau, AS., Deschênes, S., et al.[2023]

In a study of 9463 adults in South Korea, those with the highest intake of ultra-processed foods (UPF) had a 1.40 times greater likelihood of experiencing depression, indicating a potential link between diet and mental health.

The association was particularly significant in females, who showed a 1.51 times higher odds of depression with increased UPF consumption, suggesting that dietary choices may have different impacts based on sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Food Intakes Are Associated with Depression in the General Population: The Korea National Health and Nutrition Examination Survey. Lee, S., Choi, M.[2023]

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