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

NCT02801240 | Completed

• 1 other identifier: 031516
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Ulcerative; Crohn's Disease

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (10)

• 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

• Albumin, serum

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

• Red blood cell count

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

• Hemoglobin

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

• Hematocrit

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

• Vitamin B12, serum

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

• Folate, serum

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

• Sodium, serum

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

• Potassium, serum

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

• Calcium, serum

  Mean change, pre-to-post treatment, will be assessed.

  Baseline, 12 weeks

Study Arms (1)

Nutrition Support Product

EXPERIMENTAL

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

Other: Nutrition support product

Interventions

Nutrition support product OTHER

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.

Nutrition Support Product

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Jennifer J Ryan, ND, MS

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2016
• Primary Completion: December 16, 2016
• Study Completion: December 16, 2016
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)