Evaluation of an Oral Nutrition Supplement

Abbott

Status: Completed

Conditions: Gastrointestinal Tolerance

Treatments: Other: Oral Nutritional Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01902212

BL16

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

25 participants in 1 patient group

Oral Nutritional Supplement

Experimental group

Description:

2 servings a day

Treatment:

Other: Oral Nutritional Supplement