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NCT06242665 · ClinicalTrials.gov registry record · NA

You Are What You Eat: Food As a Risk Factor and a Treatment for Depression

A NA study of Depression, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
45
Enrollment target
1
Study location

NCT06242665: Completed NA study of Depression, sponsored by University of Michigan.

NCT06242665 is a NA study of Depression that has completed, run by University of Michigan. The registered enrollment target is 45 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06242665, a NA study of Depression, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
45 participants
Enrollment target
1
Study location

Study Summary

This study experimentally investigates 1) whether ultra processed food (UPF) intake contributes to depression by increasing low mood and poor sleep due to blood glucose fluctuations (which then increases the desire to consume more UPFs) and 2) to investigate the effectiveness of a 2-week meal-kit intervention that provides convenient and tasty minimally processed foods (MPF) to reduce depression. The following aims and hypotheses are tested: Aim 1: To investigate whether UPF intake and low mood contribute to each other in a cyclical fashion through the mechanisms of blood glucose fluctuations and disrupted sleep in individuals with moderate-to-severe depression. H1: It is hypothesized that UPF intake and high blood glucose will be associated with low mood in individuals with depression. Aim 2: To establish an industry partnership to investigate whether commercially available meal kit delivery reduces symptoms of depression in individuals with moderate-to-severe depression relative to a nutrition education control condition. H2: Meal kit delivery will lead to reductions in depression symptoms and daily reductions in low mood relative to the control condition (nutrition guidance only).

Primary Outcome

Depression symptoms (e.g., anhedonia, low energy) will be assessed with the Patient Health Questionnaire (PHQ-8) using ecological momentary assessment and at each study visit. The PHQ-8 scores 8 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher PHQ-8 scores indicate greater depression symptoms.

Conditions Studied

Interventions

  • OTHER Low UPF Meals (Study Provided)
  • OTHER Low UPF Nutritional Guidance
  • OTHER Low UPF Snacks (Study Provided)

Study Locations (1)

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2023-12-09
Est. Completion 2025-01-22
Phase NA
University of Michigan

1,327 total trials

What the finished NCT06242665 record still lists

NCT06242665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Low UPF Meals (Study Provided) is the first listed.

NCT06242665 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT06242665 about?

NCT06242665 is a clinical study titled "You Are What You Eat: Food As a Risk Factor and a Treatment for Depression". This study experimentally investigates 1) whether ultra processed food (UPF) intake contributes to depression by increasing low mood and poor sleep due to blood glucose fluctuations (which then increases the desire to consume more UPFs) and 2) to investigate the effectiveness of a 2-week meal-kit in...

What is the current status of trial NCT06242665?

This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2023-12-09. Estimated completion is 2025-01-22.

What conditions does trial NCT06242665 study?

This clinical trial studies the following conditions: Depression.

What interventions are being tested in trial NCT06242665?

The interventions under investigation include: Low UPF Meals (Study Provided) (OTHER), Low UPF Nutritional Guidance (OTHER), Low UPF Snacks (Study Provided) (OTHER).

Who is sponsoring clinical trial NCT06242665?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06242665 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06242665's enrollment target sits among peer trials

45 488th of 679 higher than 186 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06242665, the US trial registry maintained by the National Library of Medicine. NCT06242665 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.