Evaluation of an Oral Nutrition Supplement

Gastrointestinal Tolerance Clinical Trial

Official title:

Evaluation of an Oral Nutrition Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902212
• Other study ID #: BL16
• 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

• Gastrointestinal Tolerance

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