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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801240
• Other study ID #: 031516
• Status: Completed
• Phase: N/A
• First received: June 3, 2016
• Last updated: March 13, 2018
• Start date: June 1, 2016
• Est. completion date: December 16, 2016

Study information

• Verified date: March 2018
• Source: National University of Natural Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 16, 2016
• Est. primary completion date: December 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	National University of Natural Medicine	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National University of Natural Medicine

Country where clinical trial is conducted

United States, 

Outcome

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