Evaluation of an Oral Nutritional Supplement

NCT ID: NCT01781624

Last Updated: 2013-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Gastro-intestinal Tolerance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Study Oral Nutritional Supplement

Intervention Type OTHER

Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Interventions

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Study Oral Nutritional Supplement

Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Nelson, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Radiant Research, Inc.

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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BL13

Identifier Type: -

Identifier Source: org_study_id

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