Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of an Oral Nutrition Supplement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01902212
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tolerance Other: Oral Nutritional Supplement Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of an Oral Nutrition Supplement
Study Start Date : June 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral Nutritional Supplement
2 servings a day
Other: Oral Nutritional Supplement



Primary Outcome Measures :
  1. Gastro-Intestinal Tolerance [ Time Frame: Study Day (SD) 1-8 ]
    Subject questionnaire


Secondary Outcome Measures :
  1. ONS Consumption [ Time Frame: SD 1-8 ]
    Consumption Record

  2. Weight [ Time Frame: Screening and SD 8 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902212


Locations
Layout table for location information
France
Biofortis Sas
Saint Herblain, France, 44800
Sponsors and Collaborators
Abbott Nutrition
Investigators
Layout table for investigator information
Study Chair: Jeffrey Nelson, PhD Abbott Nutrition

Layout table for additonal information
Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01902212     History of Changes
Other Study ID Numbers: BL16
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015