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OpenTrials
Completed

NCT Number: NCT01781624

Evaluation of an Oral Nutritional Supplement

The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

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:

  • Age ≥ 60 and ≤ 90 years
  • 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
  • Currently taking or has taken antibiotic within 1 week prior to enrollment
  • Major surgery less than 3 months prior to enrollment in the study
  • Current active malignant disease or was treated within the last 6 months for cancer
  • Immunodeficiency disorder
  • Myocardial infarction within the last 3 months prior to enrollment
  • Chronic obstructive pulmonary disease (COPD)
  • Allergy to any of the ingredients in the study product
  • Aversion to flavor of product being tested
  • Obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product, inflammatory bowel disease, ulcer, gastric reflux disease, short bowel syndrome, or other major gastrointestinal disease
  • Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder
  • Pursuing or has unintentional weight loss or weight gain ≥ 5% in last 4 weeks
  • Medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility

Treatment and study plan

Study Oral Nutritional Supplement

Other

Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Primary outcomes

  1. Gastro-Intestinal Tolerance

    Time frame: Study Day 1-7

    Self-reported questionnaire

Secondary outcomes

  1. Study Product Compliance

    Time frame: Study Day 1-7

    Self-reported number of containers consumed per day

  2. Weight

    Time frame: Study Day 1 and 8

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Evaluation of an Oral Nutritional Supplement With a New Protein Blend

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2013
Registry last updated
Feb 1, 2013

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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