Evaluation of an Oral Nutritional Supplement

Abbott

Status: Completed

Conditions: Gastro-intestinal Tolerance

Treatments: Other: Study Oral Nutritional Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01781624

BL13

Details and patient eligibility

About

The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend 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:

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

Trial design

25 participants in 1 patient group

Study Oral Nutritional Supplement

Experimental group

Description:

2 containers a day of a high calorie, complete, balanced, ready-to-drink oral nutritional supplement with a new protein blend.

Treatment:

Other: Study Oral Nutritional Supplement