Evaluation of a Nutritional Product for People With Type 2 Diabetes
1 other identifier
interventional
33
1 country
2
Brief Summary
The objective of this trial is to evaluate a nutritional product for people with Diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started May 2013
Shorter than P25 for not_applicable diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMarch 3, 2015
March 1, 2015
3 months
May 6, 2013
March 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Hunger
An appetite questionnaire administered 0 to 300 minutes during each study visit.
Treatment Visit Week 1 and Treatment Visit Week 2
Secondary Outcomes (3)
Fullness
Treatment Visit Week 1 and Treatment Visit Week 2
Desire to Eat
Treatment Visit Week 1 and Treatment Visit Week 2
Prospective Consumption
Treatment Visit Week 1 and Treatment Visit Week 2
Study Arms (2)
Experimental Study Product
EXPERIMENTAL1 serving of a nutritional product for people with diabetes.
Control Study Product
PLACEBO COMPARATOR1 serving of control beverage.
Interventions
Eligibility Criteria
You may qualify if:
- 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 is \> 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (2)
Radiant Research
Chicago, Illinois, 60654, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amy Devitt-Maicher, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2013
First Posted
May 10, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
March 3, 2015
Record last verified: 2015-03