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Evaluation of a Nutritional Product for People With Type 2 Diabetes

Abbott logo

Abbott

Status

Completed

Conditions

Diabetes

Treatments

Other: Experimental Study Product
Other: Control Study Product

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The objective of this trial is to evaluate a nutritional product for people with Diabetes.

Enrollment

33 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

33 participants in 2 patient groups, including a placebo group

Experimental Study Product
Experimental group
Description:
1 serving of a nutritional product for people with diabetes.
Treatment:
Other: Experimental Study Product
Control Study Product
Placebo Comparator group
Description:
1 serving of control beverage.
Treatment:
Other: Control Study Product

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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