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

March 13, 2018 updated by: Jennifer Ryan, National University of Natural Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97201
        • National University of Natural Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 weeks
Albumin, serum
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks
Red blood cell count
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks
Hemoglobin
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks
Hematocrit
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks
Vitamin B12, serum
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks
Folate, serum
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks
Sodium, serum
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks
Potassium, serum
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks
Calcium, serum
Time Frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Natural Medicine

Investigators

  • Principal Investigator: Jennifer J Ryan, ND, MS, National University of Natural Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 16, 2016

Study Completion (Actual)

December 16, 2016

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 031516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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