Evaluation of an Oral Nutritional Supplement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01781624
First received: January 31, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Gastro-intestinal Tolerance
Other: Study Oral Nutritional Supplement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of an Oral Nutritional Supplement With a New Protein Blend

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Gastro-Intestinal Tolerance [ Time Frame: Study Day 1-7 ] [ Designated as safety issue: No ]
    Self-reported questionnaire


Secondary Outcome Measures:
  • Study Product Compliance [ Time Frame: Study Day 1-7 ] [ Designated as safety issue: No ]
    Self-reported number of containers consumed per day

  • Weight [ Time Frame: Study Day 1 and 8 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781624

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

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01781624     History of Changes
Other Study ID Numbers: BL13
Study First Received: January 31, 2013
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 25, 2014