Clinical trial NCT02945488: Exercise and Nutrition in IBD & Preconception
Official title: Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
name: Crohn's and Colitis Canada
First posted: 2016-10-26
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives are to: 1) Assess the independent and synergistic efficacy of exercise and nutrition interventions to manage major symptomatic concerns of inflammatory bowel diseases (IBD), 2) Assess the independent and synergistic efficacy of exercise and nutrition to mitigate inflammation in IBD, and 3) Assess the feasibility of such an intervention in preconception women with IBD. The investigators hypothesize that the combination of anti-inflammatory exercise and nutritional interventions will have a synergistic effect on managing major symptomatic concerns associated with IBD, reducing inflammation, and improving fertility status in preconception women with IBD, as compared to either intervention independently.

Detailed description: Potential participants will be recruited from the Preconception and Pregnancy Clinic recently established within the Saskatchewan Multidisciplinary Inflammatory Bowel Disease Clinic \[MDIBDC\]. Eligible participants will be randomized \[stratified\] to one of four groups: 1) Exercise and dietary plan, 2) Exercise and no dietary plan, 3) Stretching \[placebo exercise\] and dietary plan, 4) Stretching and no dietary plan. Participants will be assessed at baseline, midway \[3 months\], and post-intervention \[6 months\] for indications of disease activity, quality of life, fertility status, and bone health.

Eligibility criteria: Inclusion Criteria:

* Female
* Confirmed diagnosis of Inflammatory Bowel Disease
* Child-bearing age

Exclusion Criteria:

* Currently following a Mediterranean diet
* Currently performing resistance training on a regular basis (within the past 6 months)
* Failed Physical Activity Readiness Questionnaire-Plus (PAR-Q+).
* Past ileal pouch anal anastomosis
* Unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety

Primary outcomes:
measure: Change from Baseline Inflammatory Bowel Disease Questionnaire score
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Change from Baseline Interleukin-6
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Follicle Stimulating Hormone
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Leisure Time Physical Activity Questionnaire score
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Estradiol
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Total Body Lean Mass
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Total Body Fat Mass
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Body Composition
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Femoral Neck Bone Mineral Density
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Total Body Bone Mineral Density
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in Harvey Bradshaw Index
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline in partial Mayo Score
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Fecal Calprotectin
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Protein Consumption
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Carbohydrate Consumption
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Fat Consumption
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Sharyle Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References: