Evaluation of an Oral Nutritional Supplement

NCT01781624 | Completed

• 1 other identifier: BL13
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-intestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• Gastro-Intestinal Tolerance

  Self-reported questionnaire

  Study Day 1-7

Secondary Outcomes (2)

• Study Product Compliance

  Study Day 1-7

• Weight

  Study Day 1 and 8

Study Arms (1)

Study Oral Nutritional Supplement

EXPERIMENTAL

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

Interventions

Study Oral Nutritional Supplement OTHER

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

Study Oral Nutritional Supplement

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 and ≤ 90 years
• Body Mass Index (BMI) \> 20 but \< 35

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the following criteria:
• History of diabetes
• Currently taking or has taken antibiotic within 1 week prior to enrollment
• Major surgery less than 3 months prior to enrollment in the study
• Current active malignant disease or was treated within the last 6 months for cancer
• Immunodeficiency disorder
• Myocardial infarction within the last 3 months prior to enrollment
• Chronic obstructive pulmonary disease (COPD)
• Allergy to any of the ingredients in the study product
• Aversion to flavor of product being tested
• 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
• Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder
• Pursuing or has unintentional weight loss or weight gain ≥ 5% in last 4 weeks
• Medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

Location

Study Officials

• Jeffrey Nelson, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 1, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

US (1)