Gastro-intestinal ToleranceNCT01781624
Evaluation of an Oral Nutritional Supplement
A study testing Study Oral Nutritional Supplement in people with Gastro-intestinal Tolerance, run by Abbott Nutrition at 1 site in United States.
Trial summary
The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend 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
- Gastro-intestinal Tolerance
- What is being tested?
- Study 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 siteUnited States
- Study dates
- Oct 2012to Nov 2012
- 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:
- Age ≥ 60 and ≤ 90 years
- 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
- Currently taking or has taken antibiotic within 1 week prior to enrollment
- Major surgery less than 3 months prior to enrollment in the study
- Current active malignant disease or was treated within the last 6 months for cancer
- Immunodeficiency disorder
Show all 14Show fewer
- Myocardial infarction within the last 3 months prior to enrollment
- Chronic obstructive pulmonary disease (COPD)
- Allergy to any of the ingredients in the study product
- Aversion to flavor of product being tested
- Obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product, inflammatory bowel disease, ulcer, gastric reflux disease, short bowel syndrome, or other major gastrointestinal disease
- Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder
- Pursuing or has unintentional weight loss or weight gain ≥ 5% in last 4 weeks
- 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
Official title: Evaluation of an Oral Nutritional Supplement With a New Protein Blend
The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.
- Conditions
- Gastro-intestinal Tolerance
- Being tested
- Study Oral Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Oral Nutritional SupplementOther
Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.
| Study group | Role | What they receive |
|---|---|---|
| Study Oral Nutritional Supplement | Experimental | 2 containers a day of a high calorie, complete, balanced, ready-to-drink oral nutritional supplement with a new protein blend. Receives: Other: Study Oral Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-Intestinal Tolerance
Self-reported questionnaire
Measured: Study Day 1-7
Secondary outcomes (2)
Study Product Compliance
Self-reported number of containers consumed per day
Measured: Study Day 1-7
Weight
Measured: Study Day 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-intestinal 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
- Non-randomised
- 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
- NCT01781624
- Sponsor's protocol ID
- BL13
- Status last verified
- Jan 2013
- First submitted
- 31 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oral Nutritional Supplement With a New Protein Blend
- ClinicalTrials.gov ID
- NCT01781624
- Acronym / sponsor ID
- BL13
- Conditions
- Gastro-intestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Feb 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 evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Oral Nutritional Supplement | Experimental | Other: Study Oral Nutritional Supplement2 containers a day of a high calorie, complete, balanced, ready-to-drink oral nutritional supplement with a new protein blend. |
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:
- Age ≥ 60 and ≤ 90 years
- Body Mass Index (BMI) > 20 but < 35
Key exclusion criteria (14 listed)
- History of diabetes
- Currently taking or has taken antibiotic within 1 week prior to enrollment
- Major surgery less than 3 months prior to enrollment in the study
- 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 |
|---|---|---|
| Study Oral Nutritional SupplementSupplement contains a new protein mix consisting of a blend of milk, soy, and pea protein. | Other | Study Oral Nutritional Supplement |
Primary outcome
Gastro-Intestinal Tolerance
Time frame: Study Day 1-7
Self-reported questionnaire
2 secondary outcomes
Study Product Compliance
Time frame: Study Day 1-7
Weight
Time frame: Study Day 1 and 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 1 Feb 2013.
Related trials for Gastro-intestinal Tolerance
Active, not recruiting
Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes
Healthy Pregnant Women
Active, not recruiting
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
Insulin Resistance, Glucose Tolerance
RecruitingPhase 1
IKS014 in Advanced Solid Tumors That Express HER2
Breast Cancer, Gastric Cancer
Enrolling by invitationObservational study
Molecular Basis of Food Allergy
Food Allergy, Eosinophilic Esophagitis
RecruitingObservational study
Gastric Emptying and Enteral Nutrition Tolerance According to Vasopressor Dose in ICU Patients
Gastroparesis, Shock
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 Study Oral Nutritional Supplement in people with Gastro-intestinal Tolerance, run by Abbott Nutrition at 1 site in United States.
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 14 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 1 Feb 2013. 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 United States. 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 1-7). 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 1 Feb 2013.