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This study evaluates the effect of a plant-based fasting-mimicking diet on depressive symptoms in people with inflammatory bowel disease who have mild-to-moderate depression. Participants aged 18-65 with Crohn's disease or ulcerative colitis were included. The study had no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Age ≥ 18 and ≤ 65 years at the time of screening * Diagnosis of Crohn's disease in clinical remission or with mild-moderate disease with Harvey Bradshaw Index (HBI\<8) or diagnosis of ulcerative colitis in clinical remission with partial Mayo (pMayo\<7) * Suffering from mild-moderate depression with PHQ-9 ≥5 and ≤ 19 Exclusion Criteria: * Subjects who are reliant on partial or total parenteral nutrition * Subjects with prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, total colectomy, proctocolectomy, or ileoanal pouch * Subjects with diabetes or celiac disease * Subjects with a body mass index (BMI) lower than 18 * Subjects suffering from malnutrition or at high risk of malnutrition assessed by a score of ≥6 on the abridged patient generated subjective global assessment (PGSGA) * Subjects allergic to nuts * Subjects currently on a fasting/intermittent type caloric restricted diet * History of psychotic or bipolar disorders or experiencing suicidal thoughts * Pregnant women, women who are breast feeding, or women planning on becoming pregnant * Subjects with immune-compromised condition other than inflammatory bowel disease (e.g. AIDS, lymphoma) * Subjects with severe uncontrolled cardiovascular or respiratory disease or active malignancy * Unable to read English or provide informed consent