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Completed

NCT Number: NCT04259437

Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition

The purpose of this study is to evaluate the GI tolerance, palatability and compliance to a high protein energy-dense oral nutrition supplement in adult patients with or at risk of malnutrition.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Coast Medical Ltd, Newquay Health Centre, Newquay, Cornwall, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has voluntarily signed and dated informed consent form approved by Independent Ethics Committee and provided applicable privacy authorization prior to any participation in the study.
  • Subject is considered malnourished or at risk for malnutrition
  • Subject has normal GI function
  • Subject requires oral nutritional supplementation ands is willing to comply with the study protocol

Exclusion criteria

  • Subject has severe dementia, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
  • Subject has a history of diabetes
  • Subject is currently taking antibiotics or has taken antibiotics within 1 week prior to enrollment
  • Subject has undergone major GI surgery less than 3 months prior to enrollment
  • Subject has active malignant disease or was treated within the last 6 months for cancer
  • Subject has immunodeficiency disorder
  • Subject has had a myocardial infarction within the last 3 months prior to enrollment
  • Subject is known to be allergic to intolerant to an ingredient found in the study product
  • Subject has an aversion to the flavor of product being tested
  • Subject has an obstruction of the GI tract precluding ingestion or absorption of the study product, inflammatory bowel disease, gastric esophageal reflux disease, short bowel syndrome, or other major gastro-intestinal disease-causing symptoms including but not limited to uncontrollable severe diarrhea, nausea, or vomiting
  • Subject is taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility.
  • Participation in another study that has not yet been approved as a concomitant study by the Sponsor.
  • Subject has a clinical condition that is contraindicated with this product.
  • Subject is pregnant.

Treatment and study plan

High Protein, Energy Dense Nutritional Supplement

Other

Ready to drink oral supplement

Primary outcomes

  1. Gastro-Intestinal Tolerance

    Time frame: Day 1 to Day 7

    Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools.

  2. Nutritional Supplement Palatability

    Time frame: Day 1 to Day 7

    Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough

  3. Nutritional Supplement Intake

    Time frame: Day 1 to Day 7

    Subject completed daily intake questionnaire including amount of Bottle 1 and Bottle 2 consumed

  4. Nutritional Supplement Palatability

    Time frame: Day 7

    Subject completed 6, Likert Scale questions; 4 scaled in the negative direction; 2 scaled from Far Too to Not at all Enough for additional flavors

Other outcomes

  1. Medications

    Time frame: Baseline to Day 7

    Subject reported medication usage

  2. Weight

    Time frame: Baseline and Day 7

    For BMI Calculation

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

A Study to Evaluate the Gastrointestinal Tolerance and Acceptability of a High Energy, High Protein Low Volume Oral Nutritional Supplement in Adult Patients With or at Risk of Malnutrition

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2020
Registry last updated
Jun 11, 2021

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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