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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Natural Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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