Evaluation of a Nutritional Product for People With Type 2 Diabetes

Abbott

Status: Completed

Conditions: Diabetes

Treatments: Other: Experimental Study Product; Other: Control Study Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT01850810

BL17

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