ClinicalTrials.gg
CompletedNCT07426406Updated Jul 1, 2026

Oral Nutritional Supplement in Adults With or at Risk of Malnutrition

An interventional study of Experimental Nutrition Product in Gastrointestinal Tolerance, sponsored by Abbott Nutrition. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Abbott Nutrition (part of Abbott) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study.

02

Conditions studied

  • Gastrointestinal Tolerance
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 156 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , defined as 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 methods for the duration of the study.

Exclusion criteria

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 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 ).
  • 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 , 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 with this product as determined by the clinician in accordance with standard of care.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Experimental Nutrition Product

    2 servings per day

    Other: Experimental Nutrition Product

Interventions

  • OtherExperimental Nutrition Product

    High energy, high protein oral nutritional supplement

06

What researchers measure

Primary outcomes

  1. Gastrointestinal Tolerance

    Bristol Stool Form Scale; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools

    Time frame: Study Day 1 - Study Day 7

Secondary outcomes

  1. 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

    Time frame: Study Day 1 - Study Day 7

  2. Nutritional Supplement Compliance

    Subject completed daily intake questionnaire including amount of serving consumed

    Time frame: Study Day 1 - Study Day 7

Other outcomes

  1. Adverse Events

    Subject reported adverse events

    Time frame: Baseline - Study Day 8

  2. Anthropometric

    BMI calculated from Height in m and Weight in kg

    Time frame: Baseline and Study Day 8

07

Study locations

3 sites
  • North Coast Medical
    Newquay, Cornwall TR7 1RU, United Kingdom
  • Atlantic Medical Group
    Penzance, Cornwall TR18 3DX, United Kingdom
  • Hull University Teaching Hospital
    Anlaby, Hull HU3 2PA, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07426406
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Feb 23, 2026
Start date
Mar 22, 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Jul 1, 2026

Study contacts

Maria Camprubi, PhD
study chair · Abbott

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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