Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02681666
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2015-08-17
Brief Title:
Mindfulness-Based Eating in Patients With Irritable Bowel Syndrome
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
A Pilot Randomized Trial of Mindfulness-based Irritable Bowel Syndrome Eating Awareness Training as Compared to the Standard Low Fermentable Oligosaccharide Disaccharide Monosaccharide and Polyol Diet in Patients With IBS
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MB-IBS-EAT
Brief Summary:
This pilot study will be a randomized parallel trial comparing Mindfulness-Based Irritable Bowel Syndrome Eating Awareness Training done over an 8 week period to a standard low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet
Detailed Description:
This study is supported by findings that Irritable Bowel Syndrome patients have an alteration of the hypothalamus-pituitary-adrenal stress axis such that cortisol levels are elevated Stress-induced release of corticotropin-releasing factor alters gastric digestion and gastrointestinal motility Furthermore stress is a contributing factor to the immune activation and low-grade inflammation observed in Irritable Bowel Syndrome with overall physical and psychological distress correlating with percentage of activated natural killer and T cells In addition the brain-gut axis is a proposed mechanism in Irritable Bowel Syndrome due to dysregulated enteric nervous system and central nervous system events The central nervous system may perceive visceral stimuli from the gut mucosa when inflammation or injury causes afferent nerve sensitization
Regardless of the specific pathophysiologic basis of Irritable Bowel Syndrome the current aim of treatment is to improve quality of life treatments include dietary alterations and psychological therapy such as cognitive behavioral therapy to aid symptomatic relief The most common dietary intervention in patients with Irritable Bowel Syndrome is the fermentable oligosaccharide disaccharide monosaccharide and polyol restricted diet However adherence to this diet is very difficult with most patients with Irritable Bowel Syndrome failing to continue eliminating foods leading to bloating or pain Various psychological therapies have been implemented in the past with the most successful of these being cognitive behavioral therapy The beneficial results of incorporating mindfulness-based interventions to improve myriad health-related problems such as Irritable Bowel Syndrome anxiety disorders psychological distress quality of life depression fibromyalgia diabetes and eating disorders has grown considerably in the recent past Mindfulness Based Eating Awareness Training which was developed based on Jon Kabat-Zinns Mindfulness Based Stress Reduction program has been shown to improve binge eating disorder and other food and stress-related problems The effect of Mindfulness Based Eating Awareness Training is driven by the improved ability of practitioners to increase engagement in non-judgmental self-awareness behaviors designed to improve regulatory impulses and stress reactivity as well as to nurture awareness of emotional status and outside triggers The investigators have developed a 12 week Mindfulness-Based Irritable Bowel Syndrome Eating Awareness Training inspired by relevant pieces of the Mindfulness Based Eating Awareness Training program Mindfulness based interventions integrate moment by moment awareness of bodily sensations observations thoughts and feelings while suspending judgments of self Successful Irritable Bowel Syndrome treatment modalities have been elusive but have a strong food and stress-reactive association making this medical condition ideal for a mindfulness treatment intervention The usual diet for Irritable Bowel Syndrome is an elimination diet of fermentable carbohydrates of varying sugar lengths and polyols sugar alcohols and stone fruits called the Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols elimination diet Patients with Irritable Bowel Syndrome who follow a Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet receive suboptimal nutrient intake over long time periods while attempting to discern which food groups are digestible and which others are intolerable with mixed findings of improvement in quality of life and other stress-related measures
After eligibility is established written informed consent will be obtained and randomization will be conducted to place participants in either the mindfulness-based Irritable Bowel Syndrome- eating awareness training group or the Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols group and pre-baseline testing will be performed on both groups Two-four weeks later participants will receive baseline testing at their first session of both arms of the study Four weeks later participants in both study arms will receive a follow up assessment testing Directly following the eight week intervention or Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols arm participants will receive post-intervention testing 1
At 2 and 4 weeks following the intervention or Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols FODMAPs arm post-intervention testing 2 and post-intervention testing 3 will take place respectively for a total of 12 weeks
Regardless of the specific pathophysiologic basis of Irritable Bowel Syndrome the current aim of treatment is to improve quality of life treatments include dietary alterations and psychological therapy such as cognitive behavioral therapy to aid symptomatic relief The most common dietary intervention in patients with Irritable Bowel Syndrome is the fermentable oligosaccharide disaccharide monosaccharide and polyol restricted diet However adherence to this diet is very difficult with most patients with Irritable Bowel Syndrome failing to continue eliminating foods leading to bloating or pain Various psychological therapies have been implemented in the past with the most successful of these being cognitive behavioral therapy The beneficial results of incorporating mindfulness-based interventions to improve myriad health-related problems such as Irritable Bowel Syndrome anxiety disorders psychological distress quality of life depression fibromyalgia diabetes and eating disorders has grown considerably in the recent past Mindfulness Based Eating Awareness Training which was developed based on Jon Kabat-Zinns Mindfulness Based Stress Reduction program has been shown to improve binge eating disorder and other food and stress-related problems The effect of Mindfulness Based Eating Awareness Training is driven by the improved ability of practitioners to increase engagement in non-judgmental self-awareness behaviors designed to improve regulatory impulses and stress reactivity as well as to nurture awareness of emotional status and outside triggers The investigators have developed a 12 week Mindfulness-Based Irritable Bowel Syndrome Eating Awareness Training inspired by relevant pieces of the Mindfulness Based Eating Awareness Training program Mindfulness based interventions integrate moment by moment awareness of bodily sensations observations thoughts and feelings while suspending judgments of self Successful Irritable Bowel Syndrome treatment modalities have been elusive but have a strong food and stress-reactive association making this medical condition ideal for a mindfulness treatment intervention The usual diet for Irritable Bowel Syndrome is an elimination diet of fermentable carbohydrates of varying sugar lengths and polyols sugar alcohols and stone fruits called the Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols elimination diet Patients with Irritable Bowel Syndrome who follow a Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet receive suboptimal nutrient intake over long time periods while attempting to discern which food groups are digestible and which others are intolerable with mixed findings of improvement in quality of life and other stress-related measures
After eligibility is established written informed consent will be obtained and randomization will be conducted to place participants in either the mindfulness-based Irritable Bowel Syndrome- eating awareness training group or the Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols group and pre-baseline testing will be performed on both groups Two-four weeks later participants will receive baseline testing at their first session of both arms of the study Four weeks later participants in both study arms will receive a follow up assessment testing Directly following the eight week intervention or Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols arm participants will receive post-intervention testing 1
At 2 and 4 weeks following the intervention or Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols FODMAPs arm post-intervention testing 2 and post-intervention testing 3 will take place respectively for a total of 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None