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Completed
NCT06242665
You Are What You Eat: Food as a Risk Factor and a Treatment for Depression
Conditions: Depression
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 47
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
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).
Eligibility Criteria
Inclusion Criteria:
* 18+ years of age
* Must own an Android or iPhone smartphone
* Must be able to access phone one every 90 minutes
* Able to attend consent call over zoom or phone
* Endorsement of a PHQ-8 score of at least 10 assessed at consent
* Endorsement of a PHQ-8 score of at least 8 assessed 24 hours prior to Visit 1
* Endorse daily intake of at least UPF foods
* Willing to come to three in-lab visits
* Willing to follow dietary guidelines
* Must be able to speak, write, and read English fluently
Exclusion Criteria:
* Regular smoking of cigarettes or vaping of nicotine
* History of medication that impact reward, eating, or indicate severe mental health conditions (e.g., Lithium)
* The following medical conditions; Diabetes Type I, Diabetes Type II, Prediabetes, Bipolar Disorder, Schizophrenia, Psychotic Disorder, Depression with psychotic symptoms, Borderline Personality Disorder, Hypoglycemia, Substance use disorder (e.g., alcohol use disorder, opioid use disorder, cannabis use disorder), Obsessive compulsive disorder, and Post-traumatic stress disorder
* Endorsement of a suicide attempt or having been hospitalized for psychiatric reasons in the last year
* A diagnosis of a restrictive eating disorder (anorexia nervosa, bulimia nervosa, purging disorder) within the last 5 years
* History of disorders that impact eating (e.g., cancer, irritable bowel syndrome, inflammatory bowel disease, hypothyroidism).
* Current pregnancy, breast-feeding, trying to get pregnant, or within six months of having given birth
* Frequent (i.e., weekly) night shift work or irregular shifts and for abnormal sleep patterns (i.e., wake up time after 11am)
Source: ClinicalTrials.gov (NCT06242665). StuddyBuddy aggregates publicly available trial information.