Evaluation of an Oral Nutrition Supplement

The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Oral Nutritional Supplement

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Herblain, France, 44800
    • Biofortis Sas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

• Male or female ≥ 60 and ≤ 90 years of age.
• Body Mass Index (BMI) > 20 but < 35.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

• History of diabetes
• Antibiotic use within 1 week prior to enrollment
• Undergone major surgery less than 3 months prior to enrollment.
• Current active malignant disease or was treated within the last 6 months for cancer.
• Immunodeficiency disorder.
• Myocardial infarction within the last 3 months.
• Chronic obstructive pulmonary disease (COPD).
• Allergy to any of the ingredients in the study product.
• Obstruction of the gastrointestinal tract or other major gastrointestinal disease.
• Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder.
• Unintentional weight loss or weight gain ≥ 5% in last 4 weeks.
• Taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Nutritional Supplement; 2 servings a day	Other: Oral Nutritional Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastro-Intestinal Tolerance	Subject questionnaire	Study Day (SD) 1-8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ONS Consumption	Consumption Record	SD 1-8
Weight		Screening and SD 8

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jeffrey Nelson, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (Estimate): July 18, 2013

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: BL16