Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

Last updated: August 30, 2024
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

1

Condition

Depression

Ulcerative Colitis

Ulcers

Treatment

Plant-based fasting-mimicking diet

Clinical Study ID

NCT05382897
Pro00115405
  • Ages 18-65
  • All Genders

Study Summary

Inflammatory bowel disease (IBD) is a chronic illness characterized by inflammation of the intestine. Many individuals with IBD suffer from depressive symptoms and anxiety which can lead to a decreased quality of life, poor treatment compliance, and higher morbidity and mortality. The object of this clinical trial is to investigate the effects of a fasting mimicking diet in IBD patients who are suffering with symptoms of depression. Participants will carry out 3 cycles of a 5-day period of a plant-based low caloric diet or a plant-based caloric sufficient diet following by 3 weeks of eating normally. Effects of the dietary intervention on microbes in the gut, immune and metabolic function, and depressive symptoms will be measured. The overall goal is to develop a safe and effective treatment to improve mental health in patients with IBD by targeting the gut microbiome through dietary interventions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 and ≤ 65 years at the time of screening

  • Diagnosis of Crohn's disease in clinical remission or with mild-moderate diseasewith Harvey Bradshaw Index (HBI<8) or diagnosis of ulcerative colitis in clinicalremission with partial Mayo (pMayo<7)

  • Suffering from mild-moderate depression with PHQ-9 ≥5 and ≤ 19

Exclusion

Exclusion Criteria:

  • Subjects who are reliant on partial or total parenteral nutrition

  • Subjects with prior gastrointestinal surgery and consequences such as short bowelsyndrome, ostomy of small or large intestine, total colectomy, proctocolectomy, orileoanal 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 ascore 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 activemalignancy

  • Unable to read English or provide informed consent

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Plant-based fasting-mimicking diet
Phase: 1
Study Start date:
July 01, 2022
Estimated Completion Date:
December 31, 2025

Study Description

The primary objective of this proof of principle study is to investigate the effects of a fasting mimicking diet on depressive symptoms in patients with inflammatory bowel disease.

The specific aims of this project include:

  1. Determine whether a fasting-mimicking diet is effective in ameliorating depressive symptoms in patients with Crohn's disease or ulcerative colitis

  2. Determine if beneficial effects seen during the interventional period are sustained following cessation of fasting

  3. Examine effects of the intervention on the gut microbiome and metabolome

Connect with a study center

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2E1
    Canada

    Active - Recruiting

  • University of Alberta Human Nutrition Research Unit

    Edmonton, Alberta T6G 2E1
    Canada

    Active - Recruiting

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