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

Primary Purpose

Colitis, Ulcerative, Crohn's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition support product
Sponsored by
National University of Natural Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colitis, Ulcerative focused on measuring Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University of Natural Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutrition Support Product

Arm Description

Participants will be asked to take a nutrition support product twice per day for a period of 12 weeks.

Outcomes

Primary Outcome Measures

Overall nutritional status
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.
Albumin, serum
Mean change, pre-to-post treatment, will be assessed.
Red blood cell count
Mean change, pre-to-post treatment, will be assessed.
Hemoglobin
Mean change, pre-to-post treatment, will be assessed.
Hematocrit
Mean change, pre-to-post treatment, will be assessed.
Vitamin B12, serum
Mean change, pre-to-post treatment, will be assessed.
Folate, serum
Mean change, pre-to-post treatment, will be assessed.
Sodium, serum
Mean change, pre-to-post treatment, will be assessed.
Potassium, serum
Mean change, pre-to-post treatment, will be assessed.
Calcium, serum
Mean change, pre-to-post treatment, will be assessed.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2016
Last Updated
March 13, 2018
Sponsor
National University of Natural Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02801240
Brief Title
Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease
Official Title
Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 16, 2016 (Actual)
Study Completion Date
December 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Natural Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Crohn's Disease
Keywords
Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Support Product
Arm Type
Experimental
Arm Description
Participants will be asked to take a nutrition support product twice per day for a period of 12 weeks.
Intervention Type
Other
Intervention Name(s)
Nutrition support product
Intervention Description
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 Measure Information:
Title
Overall nutritional status
Description
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.
Time Frame
Baseline, 12 weeks
Title
Albumin, serum
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks
Title
Red blood cell count
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks
Title
Hemoglobin
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks
Title
Hematocrit
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks
Title
Vitamin B12, serum
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks
Title
Folate, serum
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks
Title
Sodium, serum
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks
Title
Potassium, serum
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks
Title
Calcium, serum
Description
Mean change, pre-to-post treatment, will be assessed.
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer J Ryan, ND, MS
Organizational Affiliation
National University of Natural Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Natural Medicine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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