Evaluation of an Oral Nutritional Supplement

Gastro-intestinal Tolerance Clinical Trial

Official title:

Evaluation of an Oral Nutritional Supplement With a New Protein Blend

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781624
• Other study ID #: BL13
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: January 31, 2013
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

1. Age = 60 and = 90 years

2. Body Mass Index (BMI) > 20 but < 35

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. History of diabetes

2. Currently taking or has taken antibiotic within 1 week prior to enrollment

3. Major surgery less than 3 months prior to enrollment in the study

4. Current active malignant disease or was treated within the last 6 months for cancer

5. Immunodeficiency disorder

6. Myocardial infarction within the last 3 months prior to enrollment

7. Chronic obstructive pulmonary disease (COPD)

8. Allergy to any of the ingredients in the study product

9. Aversion to flavor of product being tested

10. Obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product, inflammatory bowel disease, ulcer, gastric reflux disease, short bowel syndrome, or other major gastrointestinal disease

11. Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder

12. Pursuing or has unintentional weight loss or weight gain = 5% in last 4 weeks

13. Medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastro-intestinal Tolerance

Intervention

Other:
• Study Oral Nutritional Supplement
Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastro-Intestinal Tolerance	Self-reported questionnaire	Study Day 1-7	No
Secondary	Study Product Compliance	Self-reported number of containers consumed per day	Study Day 1-7	No
Secondary	Weight		Study Day 1 and 8	No