Gastrointestinal ToleranceNCT01902212
Evaluation of an Oral Nutrition Supplement
A study testing Oral Nutritional Supplement in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 1 site in France.
Trial summary
The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Oral Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- Male or female ≥ 60 and ≤ 90 years of age.
- Body Mass Index (BMI) > 20 but < 35.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- History of diabetes
- Antibiotic use within 1 week prior to enrollment
- Undergone major surgery less than 3 months prior to enrollment.
- Current active malignant disease or was treated within the last 6 months for cancer.
- Immunodeficiency disorder.
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- Myocardial infarction within the last 3 months.
- Chronic obstructive pulmonary disease (COPD).
- Allergy to any of the ingredients in the study product.
- Obstruction of the gastrointestinal tract or other major gastrointestinal disease.
- Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder.
- Unintentional weight loss or weight gain ≥ 5% in last 4 weeks.
- Taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Oral Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional SupplementOther
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement | Experimental | 2 servings a day Receives: Other: Oral Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-Intestinal Tolerance
Subject questionnaire
Measured: Study Day (SD) 1-8
Secondary outcomes (2)
ONS Consumption
Consumption Record
Measured: SD 1-8
Weight
Measured: Screening and SD 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Nelson, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902212
- Sponsor's protocol ID
- BL16
- Status last verified
- Mar 2015
- First submitted
- 3 Jul 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oral Nutrition Supplement
- ClinicalTrials.gov ID
- NCT01902212
- Acronym / sponsor ID
- BL16
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement | Experimental | Other: Oral Nutritional Supplement2 servings a day |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- Male or female ≥ 60 and ≤ 90 years of age.
- Body Mass Index (BMI) > 20 but < 35.
Key exclusion criteria (13 listed)
- History of diabetes
- Antibiotic use within 1 week prior to enrollment
- Undergone major surgery less than 3 months prior to enrollment.
- Current active malignant disease or was treated within the last 6 months for cancer.
- Immunodeficiency disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional Supplement | Other | Oral Nutritional Supplement |
Primary outcome
Gastro-Intestinal Tolerance
Time frame: Study Day (SD) 1-8
Subject questionnaire
2 secondary outcomes
ONS Consumption
Time frame: SD 1-8
Weight
Time frame: Screening and SD 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Nelson, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastro-Intestinal Tolerance (time frame: Study Day (SD) 1-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.