Evaluation of an Oral Nutritional Supplement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781624
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gastro-intestinal Tolerance Other: Study Oral Nutritional Supplement

Study Type : Interventional  (Clinical Trial)
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 : October 2012
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Gastro-Intestinal Tolerance [ Time Frame: Study Day 1-7 ]
    Self-reported questionnaire

Secondary Outcome Measures :
  1. Study Product Compliance [ Time Frame: Study Day 1-7 ]
    Self-reported number of containers consumed per day

  2. Weight [ Time Frame: Study Day 1 and 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01781624

United States, Ohio
Radiant Research, Inc.
Cincinnati, Ohio, United States, 45249
Sponsors and Collaborators
Abbott Nutrition
Study Chair: Jeffrey Nelson, PhD Abbott Nutrition

Responsible Party: Abbott Nutrition Identifier: NCT01781624     History of Changes
Other Study ID Numbers: BL13
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013