Gastrointestinal Tolerance Clinical Trial
Official title:
Evaluation of an Oral Nutrition Supplement
Verified date | March 2015 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Institutional Review Board |
Study type | Interventional |
The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.
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. |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Biofortis Sas | Saint Herblain |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
France,
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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