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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04945083
Other study ID # BL55
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 13, 2021
Est. completion date December 9, 2021

Study information

Verified date January 2022
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental Nutritional Pudding
High Calorie, High Protein pudding

Locations

Country Name City State
United Kingdom North Coast Medical Ltd, Newquay Health Centre Newquay Cornwall
United Kingdom Morrab Surgery Penzance Cornwall
United Kingdom The Alverton Practice, Atlantic Medical Penzance Cornwall

Sponsors (1)

Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Weight For BMI Calculation Baseline to Study Day 28
Other Height For BMI Calculation Baseline to Study Day 28
Other Medication Usage Subject reported medication usage Baseline to Study Day 28
Other Adverse Events Subject reported adverse events Baseline to Study Day 28
Primary Gastro-Intestinal Tolerance Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools Study Day 1 to Study Day 8
Secondary Nutritional Supplement Palatability Subject completed questionnaire; 4 questions scaled from 1 -Dislike Extremely to 9-Like Extremely; 2 questions scaled from Not at all Enough to Far Too Study Day 1 to Study Day 8
Secondary Nutritional Supplement Compliance Subject completed daily intake questionnaire including amount of serving consumed Study Day 1 to Study Day 28
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