Exercise and Nutrition in IBD & Preconception

Inflammatory Bowel Diseases Clinical Trial

— IBDPreconcep  

Official title:

Exercise and Nutrition as Treatment Alternatives in Women With Inflammatory Bowel Disease During Preconception: Saskatchewan Multidisciplinary Inflammatory Bowel Diseases Clinic (MDIBDC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02945488
• Other study ID #: 16-132
• Status: Terminated
• Phase: N/A
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: June 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Exercise
Exercise intervention will entail 30 minutes of moderate intensity cardiovascular training 3 days/week and full body resistance training 2 days/week (supervised). Cardiovascular training will entail any weight-bearing activity that would achieve target heart rate, such as walking, jogging, stair climbing, dancing, etc. Resistance training will entail 2-3 sets of 8-12 repetitions of exercises targeting all major muscle groups with an external load applied, such as a dumbbell, barbell, medicine ball, etc.
• Dietary plan
Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.
• Stretching
Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (3)

Lead Sponsor	Collaborator
University of Saskatchewan	Crohn's and Colitis Canada, Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Inflammatory Bowel Disease Questionnaire score	Inflammatory Bowel Disease Questionnaire (score on a scale); measures quality of life	Baseline, 3 months, and 6 months
Secondary	Change from Baseline Interleukin-6	Serum Interleukin-6 (pg/mL); measures inflammation	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Follicle Stimulating Hormone	Serum Follicle Stimulating Hormone (mIU/ml); measures fertility status	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Leisure Time Physical Activity Questionnaire score	Leisure Time Physical Activity Questionnaire (arbitrary score); measures physical activity levels outside intervention	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Estradiol	Serum estradiol (pg/mL); measures fertility status	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Total Body Lean Mass	Total body lean mass (grams) via dual energy x-ray absorptiometry scan; measures body composition	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Total Body Fat Mass	Total body fat mass (grams) via dual energy x-ray absorptiometry scan; measures body composition	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Body Composition	Body fat percentage (%) via dual energy x-ray absorptiometry scan; measures body composition	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Femoral Neck Bone Mineral Density	Femoral neck bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measures bone health	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Total Body Bone Mineral Density	Total body bone mineral density (g/cm^2) via dual energy x-ray absorptiometry scan; measure bone health	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in Harvey Bradshaw Index	Harvey Bradshaw Index for Crohn's disease (score on a scale); measures clinical disease activity	Baseline, 3 months, and 6 months
Secondary	Change from Baseline in partial Mayo Score	Partial Mayo Score for ulcerative colitis (score on a scale); measures clinical disease activity	Baseline, 3 months, and 6 months
Secondary	Change from Baseline Fecal Calprotectin	Fecal calprotectin (mg/kg); measures clinical disease activity	Baseline, 3 months, and 6 months
Secondary	Change from Baseline Protein Consumption	Food Frequency Questionnaire average protein consumption per day (grams); measures nutritional status	Baseline, 3 months, and 6 months
Secondary	Change from Baseline Carbohydrate Consumption	Food Frequency Questionnaire average carbohydrate consumption per day (grams); measures nutritional status	Baseline, 3 months, and 6 months
Secondary	Change from Baseline Fat Consumption	Food Frequency Questionnaire average fat consumption per day (grams); measures nutritional status	Baseline, 3 months, and 6 months
Secondary	Change from Baseline EuroQol Five Dimensions Questionnaire (EQ-5D) score	The EQ-5D (score on a scale); measures quality of life	Baseline, 3 months, and 6 months