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Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801240
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Ryan, National University of Natural Medicine

Brief Summary:
Individuals with IBD are at risk for nutrient deficiencies. This prospective, non-randomized, open-label study will assess the effect of a nutrition support product on nutritional status in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's disease will be enrolled in the study and asked to take the product for 12 weeks. The primary measures of the study are several blood markers of nutritional status.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Crohn's Disease Other: Nutrition support product Not Applicable

Detailed Description:
It is estimated that 1-1.3 million people in the United States suffer from the Inflammatory Bowel Diseases (IBD) Crohn's disease (CD) and Ulcerative colitis (UC). The pathophysiology of IBD involves malnutrition, malabsorption, altered intestinal permeability, inflammation, and gut flora alterations. Individuals with IBD are at risk for nutrient deficiencies due to decreased intake, decreased absorption and/or increased enteral losses. The most common deficiencies involve many micronutrients including vitamins and minerals; less commonly, adults may also be at risk for macronutrient deficiencies involving protein and total energy intake. The product being studied is a comprehensive nutrition support product that was formulated to meet the nutritional needs of individuals with digestive complaints. This study will assess the effect of the study product on blood markers of nutritional status in adults with IBD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 16, 2016
Actual Study Completion Date : December 16, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutrition Support Product
Participants will be asked to take a nutrition support product twice per day for a period of 12 weeks.
Other: Nutrition support product
Nutrition support product contains macronutrients, micronutrients, phytonutrients, prebiotics, and glutamine. Product is in powder form and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.




Primary Outcome Measures :
  1. Overall nutritional status [ Time Frame: Baseline, 12 weeks ]
    The effect on overall nutritional status will be determined by aggregating data from multiple measures (albumin, red blood cell count, hemoglobin, hematocrit, vitamin B12, folate, sodium, potassium and calcium) into one reported value. The proportion (percentage) of abnormal values present at baseline will be calculated and compared to the proportion of abnormal values present at the end of the study. Mean change, pre-to-post treatment, will also be assessed for each individual measure.

  2. Albumin, serum [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.

  3. Red blood cell count [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.

  4. Hemoglobin [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.

  5. Hematocrit [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.

  6. Vitamin B12, serum [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.

  7. Folate, serum [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.

  8. Sodium, serum [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.

  9. Potassium, serum [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.

  10. Calcium, serum [ Time Frame: Baseline, 12 weeks ]
    Mean change, pre-to-post treatment, will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70
  • Ulcerative colitis or Crohn's disease (currently active/not considered in remission)
  • Willing to have blood drawn twice and willing to fast for 10-12 hours before blood draws
  • Able to speak, read and understand English

Exclusion Criteria:

  • Currently taking a nutrition support product (macronutrient/micronutrient support product consumed as a reconstituted beverage) or was taken within the last 28 days
  • Currently receiving intravenous nutrition support therapy (or within the last 28 days)
  • Currently taking curcumin, turmeric, fenugreek, hops, rosemary, ginger or quercetin (or they were taken within the last 14 days)
  • Currently taking anti-coagulant or anti-platelet prescription medications (or they were taken within the last 28 days)
  • Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within the last 28 days)
  • Initiation of or changes to supplements or medications within 28 days prior to screening
  • Initiation of or changes to an exercise regimen within 28 days prior to screening
  • Initiation of or changes to a food plan within 28 days prior to screening
  • Current involvement or within 28 days prior to screening of a significant diet or weight loss program
  • Hospitalization (for any reason other than a scheduled medical procedure) within 3 months prior to screening
  • Gastrointestinal surgery within 3 months prior to screening
  • Currently have a colostomy or ileostomy bag in place
  • Malignancy within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)
  • Women who are lactating, pregnant or planning pregnancy within the next four months
  • Difficulty or aversion to taking powdered drink mixes or nutritional shakes
  • Currently participating in another interventional research study or participated in another interventional study within the previous 28 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801240


Locations
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United States, Oregon
National University of Natural Medicine
Portland, Oregon, United States, 97201
Sponsors and Collaborators
National University of Natural Medicine
Investigators
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Principal Investigator: Jennifer J Ryan, ND, MS National University of Natural Medicine
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Responsible Party: Jennifer Ryan, Postdoctoral Fellow, National University of Natural Medicine
ClinicalTrials.gov Identifier: NCT02801240    
Other Study ID Numbers: 031516
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jennifer Ryan, National University of Natural Medicine:
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases