Evaluation of an Oral Nutritional Supplement

• Sponsor: Abbott Nutrition (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01781624
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 24.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastro-intestinal Tolerance	Other: Study Oral Nutritional Supplement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Evaluation of an Oral Nutritional Supplement With a New Protein Blend
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Oral Nutritional Supplement 2 containers a day of a high calorie, complete, balanced, ready-to-drink oral nutritional supplement with a new protein blend.	Other: Study Oral Nutritional Supplement; Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Outcome Measures

Primary Outcome Measures

1. Gastro-Intestinal Tolerance [Study Day 1-7]

   Self-reported questionnaire

Secondary Outcome Measures

1. Study Product Compliance [Study Day 1-7]

   Self-reported number of containers consumed per day

2. Weight [Study Day 1 and 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research, Inc.	Cincinnati	Ohio	United States	45249

Sponsors and Collaborators

• Abbott Nutrition

Investigators

• Study Chair: Jeffrey Nelson, PhD, Abbott Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Nutrition
• ClinicalTrials.gov Identifier: NCT01781624
• Other Study ID Numbers: BL13
• First Posted: Feb 1, 2013
• Last Update Posted: Feb 1, 2013
• Last Verified: Jan 1, 2013

Study Results

No Results Posted as of Feb 1, 2013