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OpenTrials
Completed

NCT Number: NCT01902212

Evaluation of an Oral Nutrition Supplement

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

Completed

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis Sas

Saint-Herblain, 44800, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Nutritional Supplement

Other

Primary outcomes

  1. Gastro-Intestinal Tolerance

    Time frame: Study Day (SD) 1-8

    Subject questionnaire

Secondary outcomes

  1. ONS Consumption

    Time frame: SD 1-8

    Consumption Record

  2. Weight

    Time frame: Screening and SD 8

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2013
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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