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Evaluation of a Nutritional Product for People With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01850810
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this trial is to evaluate a nutritional product for people with Diabetes.

Condition or disease Intervention/treatment
Diabetes Other: Experimental Study Product Other: Control Study Product

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Evaluation of a Nutritional Product for People With Type 2 Diabetes (T2DM)
Study Start Date : May 2013
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental Study Product
1 serving of a nutritional product for people with diabetes.
Other: Experimental Study Product
Other Name: Oral nutritional supplement for people with Diabetes.
Placebo Comparator: Control Study Product
1 serving of control beverage.
Other: Control Study Product
Other Name: Water beverage.


Outcome Measures

Primary Outcome Measures :
  1. Hunger [ Time Frame: Treatment Visit Week 1 and Treatment Visit Week 2 ]
    An appetite questionnaire administered 0 to 300 minutes during each study visit.


Secondary Outcome Measures :
  1. Fullness [ Time Frame: Treatment Visit Week 1 and Treatment Visit Week 2 ]
    An appetite questionnaire administered 0 to 300 minutes during each study visit.

  2. Desire to Eat [ Time Frame: Treatment Visit Week 1 and Treatment Visit Week 2 ]
    An appetite questionnaire administered 0 to 300 minutes during each study visit.

  3. Prospective Consumption [ Time Frame: Treatment Visit Week 1 and Treatment Visit Week 2 ]
    An appetite questionnaire administered 0 to 300 minutes during each study visit.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be eligible for the study if they meet all of the following inclusion criteria:

    1. Diagnosis of Type 2 Diabetes.
    2. Age between 18 and 75 years.
    3. HbA1c > 6.0 but ≤ 8.5
    4. 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.
    5. BMI is > 18.5 kg/m2 and < 40.0 kg/m2.
    6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.
    7. Subject states that they are a habitual consumer of a morning meal.

Exclusion Criteria:

  • Subjects will be excluded from the study if they meet any of the following criteria:

    1. Use of exogenous insulin or GLP-1 agonists for glucose control.
    2. Diagnosis of Type 1 diabetes.
    3. History of diabetic ketoacidosis.
    4. 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.
    5. Active malignancy.
    6. Significant cardiovascular event < 12 weeks prior to study entry.
    7. End stage organ failure or status post organ transplant.
    8. Active metabolic, hepatic, or gastrointestinal disease.
    9. Chronic, contagious, infectious disease.
    10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
    11. History of fainting or other adverse reactions in response to blood collection.
    12. Clotting or bleeding disorders.
    13. Allergy or intolerance to study product ingredient.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850810


Locations
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60654
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45249
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Amy Devitt-Maicher, PhD Abbott Nutrition
More Information

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01850810     History of Changes
Other Study ID Numbers: BL17
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases