DiabetesNCT01850134
Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.
A study testing Experimental Study Product in people with Diabetes, run by Abbott Nutrition at 2 sites in United States.
Trial summary
The objective of this trial is to evaluate a nutritional supplement for people with Diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Experimental Study Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Jul 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 18 to 75 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:
- Diagnosis of Type 2 Diabetes.
- Age between 18 and 75 years.
- HbA1c > 6.0 but ≤ 8.5
- If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
- BMI > 18.5 kg/m2 and < 40.0 kg/m2.
- Chronic medication dosage must be stable for at least two months prior to Screening Visit.
- Subject states that they are a habitual consumer of a morning meal.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- Use of exogenous insulin or GLP-1 agonists for glucose control.
- Diagnosis of Type 1 diabetes.
- History of diabetic ketoacidosis.
- Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
- Active malignancy.
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- Significant cardiovascular event < 12 weeks prior to study entry.
- End stage organ failure or status post organ transplant.
- Active metabolic, hepatic, or gastrointestinal disease.
- Chronic, contagious, infectious disease.
- Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
- History of fainting or other adverse reactions in response to blood collection.
- Clotting or bleeding disorders.
- Allergy or intolerance to study product ingredient.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Biofortis Clinical Research
Addison, Illinois, 60101
Radiant Research
Cincinnati, Ohio, 45249
About this study
Official title: Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).
The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.
- Conditions
- Diabetes
- Being tested
- Experimental Study Product, Control Study Product
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Study ProductOther
Also called Oral nutritional supplement for people with Diabetes.
Control Study ProductOther
Also called Water beverage.
| Study group | Role | What they receive |
|---|---|---|
| Control Study Product | Placebo comparator | 1 serving of control beverage. Receives: Other: Control Study Product |
| Experimental Study Product | Experimental | 1 serving of a nutritional supplement for people with diabetes. Receives: Other: Experimental Study Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger
An appetite questionnaire evaluating change from baseline during each study visit.
Measured: Treatment Visit 1 and Treatment Visit 2
Secondary outcomes (3)
Fullness
An appetite questionnaire evaluating change from baseline during each study visit.
Measured: Treatment Visit 1 and Treatment Visit 2
Desire to Eat
An appetite questionnaire evaluating change from baseline during each study visit.
Measured: Treatment Visit 1 and Treatment Visit 2
Prospective Consumption
An appetite questionnaire evaluating change from baseline during each study visit.
Measured: Treatment Visit 1 and Treatment Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Devitt-Maicher, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850134
- Sponsor's protocol ID
- BL18
- Status last verified
- Jul 2016
- First submitted
- 7 May 2013
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).
- ClinicalTrials.gov ID
- NCT01850134
- Acronym / sponsor ID
- BL18
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 9 May 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 trial is to evaluate a nutritional supplement for people with Diabetes.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Study Product | Placebo comparator | Other: Control Study Product1 serving of control beverage. |
| Experimental Study Product | Experimental | Other: Experimental Study Product1 serving of a nutritional supplement for people with diabetes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will be eligible for the study if they meet all of the following inclusion criteria:
Key exclusion criteria (14 listed)
- Subjects will be excluded from the study if they meet any of the following criteria:
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 |
|---|---|---|
| Experimental Study ProductAlso: Oral nutritional supplement for people with Diabetes. | Other | Experimental Study Product |
| Control Study ProductAlso: Water beverage. | Other | Control Study Product |
Primary outcome
Hunger
Time frame: Treatment Visit 1 and Treatment Visit 2
An appetite questionnaire evaluating change from baseline during each study visit.
3 secondary outcomes
Fullness
Time frame: Treatment Visit 1 and Treatment Visit 2
Desire to Eat
Time frame: Treatment Visit 1 and Treatment Visit 2
Prospective Consumption
Time frame: Treatment Visit 1 and Treatment Visit 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
Amy Devitt-Maicher, PhD study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Study Product in people with Diabetes, run by Abbott Nutrition at 2 sites 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 8 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: withdrawn, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hunger (time frame: Treatment Visit 1 and Treatment Visit 2). 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 13 Jul 2016.