Evaluation of an Oral Nutritional Supplement

Not Applicable

Completed

• Conditions: Gastro-intestinal Tolerance

• Registration Number: NCT01781624
• Lead Sponsor: Abbott Nutrition

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Study First Posted: 2013-02-01
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Gastro-Intestinal Tolerance	Study Day 1-7	Self-reported questionnaire

Secondary Outcome Measures

Name	Time	Method
Weight	Study Day 1 and 8
Study Product Compliance	Study Day 1-7	Self-reported number of containers consumed per day

Trial Locations

Locations (1)

Radiant Research, Inc.; 🇺🇸 Cincinnati, Ohio, United States