Colitis, UlcerativeNCT02801240
Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease
A study testing Nutrition support product in people with Colitis, Ulcerative and Crohn's Disease, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colitis, Ulcerative, Crohn's Disease
- What is being tested?
- Nutrition support product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 16 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Natural Medicine
Portland, Oregon, 97201
About this study
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.
Read the 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.
- Conditions
- Colitis, Ulcerative, Crohn's Disease
- Being tested
- Nutrition support product
- Keywords
- Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition support productOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Support Product | Experimental | Participants will be asked to take a nutrition support product twice per day for a period of 12 weeks. Receives: Other: Nutrition support product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks
Albumin, serum
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Red blood cell count
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Hemoglobin
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Hematocrit
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Vitamin B12, serum
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Folate, serum
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Sodium, serum
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Potassium, serum
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Calcium, serum
Mean change, pre-to-post treatment, will be assessed.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion16 Dec 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Ryan, National University of Natural Medicine
- Investigators
- Jennifer J Ryan, ND, MS, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801240
- Sponsor's protocol ID
- 031516
- Status last verified
- Mar 2018
- First submitted
- 3 Jun 2016
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02801240
- Acronym / sponsor ID
- 031516
- Conditions
- Colitis, Ulcerative, Crohn's Disease
- Keywords
- Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Support Product | Experimental | Other: Nutrition support productParticipants will be asked to take a nutrition support product twice per day for a period of 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition support productNutrition 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. | Other | Nutrition Support Product |
Primary outcome
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.
Albumin, serum
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Red blood cell count
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Hemoglobin
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Hematocrit
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Vitamin B12, serum
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Folate, serum
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Sodium, serum
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Potassium, serum
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Calcium, serum
Time frame: Baseline, 12 weeks
Mean change, pre-to-post treatment, will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer J Ryan, ND, MS principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition support product in people with Colitis, Ulcerative and Crohn's Disease, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall nutritional status (time frame: Baseline, 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.