Gastrointestinal Tolerance
Conditions
Brief summary
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study.
Interventions
OTHERExperimental Nutrition Product
High energy, high protein oral nutritional supplement
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has voluntarily signed and dated an ICF approved by an EC and provided applicable privacy authorization prior to any participation in the study. * Participant (male or female) is ≥ 18 years of age. * Participant is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of ONS, recently identified as malnourished or at risk of malnutrition based on a validated malnutrition screening tool, or has had weight loss within the last two months as a result of a hospitalization or a chronic illness. * Participant currently has normal GI function. * Participant requires ONS as assessed by a dietitian or clinician and is willing to comply with the study protocol for at least 7 days. * Non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the screening visit. A urine pregnancy test is required for all female participants unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to the screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). * If participant is of childbearing potential, the participant must agree to use effective forms of birth control methods for the duration of the study.
Exclusion criteria
* Participant has severe dementia or delirium, 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. * Participant has a history of uncontrolled diabetes as evidenced by HbA1c of \> 9% within the last six months. * Participant is currently taking or has taken antibiotics within 1 week prior to the feeding period (SDay 1 may be delayed until such time that the participant has completed a one-week washout period). * Participant has undergone major GI surgery less than 3 months prior to enrollment in the study. * Participant has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment. * Participant has an allergy or intolerance to any ingredient in the study nutritional product. * Participant has an aversion to all of the flavours of product being assessed. * Participant 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 gastrointestinal disease-causing symptoms including (but not limited to) uncontrollable severe diarrhea, nausea, or vomiting. Exceptions include well-controlled reflux symptoms defined as no change in medication in the last 3 months. * Participant is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility. Exceptions include multivitamins/mineral supplements, optical steroids, and inhaled steroids for asthma. * Participation in another study that has not been approved as a concomitant study by Abbott. * Participant has a clinical condition that is contraindicated with this product as determined by the clinician in accordance with standard of care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance | Study Day 1 - Study Day 7 | Bristol Stool Form Scale; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional Supplement Palatability | Study Day 1 - Study Day 7 | 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 |
| Nutritional Supplement Compliance | Study Day 1 - Study Day 7 | Subject completed daily intake questionnaire including amount of serving consumed |
Countries
United Kingdom
Contacts
STUDY_CHAIRMaria Camprubi, PhD
Abbott
Outcome results
None listed