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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a pilot open label crossover trial to assess the feasibility and acceptability of reducing ultra- processed foods (UPF) in a personalized manner from the diets of patients with major depressive disorder who eat a large percentage of UPF.

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.

What data supports the effectiveness of the treatment Reduction of Ultra-processed foods for depression?

Research shows that eating a lot of ultra-processed foods is linked to a higher risk of depression. Studies from different countries, including France, Brazil, and Korea, found that people who eat more of these foods are more likely to experience depressive symptoms. ^{1 2 3 4 5}

Is reducing ultra-processed food intake safe for humans?

The research does not specifically address the safety of reducing ultra-processed food intake, but it suggests that high consumption of ultra-processed foods is linked to various health issues, including depression, obesity, diabetes, and cardiovascular disease. Reducing these foods may potentially lower these risks, implying a generally safe approach. ^{2 4 6 7 8}

How does the treatment of reducing ultra-processed foods differ from other treatments for depression?

This treatment is unique because it focuses on dietary changes, specifically reducing the intake of ultra-processed foods, which have been linked to an increased risk of depression. Unlike medications or therapy, this approach targets the potential impact of diet on mental health, offering a non-pharmacological option for managing depressive symptoms. ^{1 2 4 5 9}

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

Eligibility Criteria

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.

I eat enough to maintain a healthy weight.

I agree not to change my mental health medications or therapy during the study.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Association between ultra-processed foods and recurrence of depressive symptoms: the Whitehall II cohort study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Prospective association between ultra-processed food consumption and incident depressive symptoms in the French NutriNet-Santé cohort. [2020]

3. Switzerland 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. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

Ultra-processed food intake and risk of depression: a systematic review. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Ultra-processed food consumption is positively associated with the incidence of depression in Brazilian adults (CUME project). [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

[What is ultra-processed food and how is it related to diet-related diseases?] [2022]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Association of ultra-processed food consumption with incident depression and anxiety: a population-based cohort study. [2023]

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

Ultra-Processed Food Consumption and Depressive Symptoms in a Mediterranean Cohort. [2023]