Evaluation of an Oral Nutrition Supplement

NCT ID: NCT01902212

Last Updated: 2015-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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Conditions

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Gastrointestinal Tolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Oral Nutritional Supplement

2 servings a day

Group Type EXPERIMENTAL

Oral Nutritional Supplement

Intervention Type OTHER

Interventions

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Oral Nutritional Supplement

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Nelson, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Biofortis Sas

Saint-Herblain, , France

Site Status

Countries

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France

Other Identifiers

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BL16

Identifier Type: -

Identifier Source: org_study_id

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