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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01902212
Other study ID # BL16
Secondary ID
Status Completed
Phase N/A
First received July 3, 2013
Last updated March 2, 2015
Start date June 2013
Est. completion date September 2013

Study information

Verified date March 2015
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority France: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 90 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Oral Nutritional Supplement


Locations

Country Name City State
France Biofortis Sas Saint Herblain

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastro-Intestinal Tolerance Subject questionnaire Study Day (SD) 1-8 No
Secondary ONS Consumption Consumption Record SD 1-8 No
Secondary Weight Screening and SD 8 No
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