Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.

Not Applicable

Withdrawn

• Conditions: Diabetes
• Interventions: Other: Control Study Product; Other: Experimental Study Product

• Registration Number: NCT01850134
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-09
• Study Start: 2013-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 > 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Study Product	Control Study Product	1 serving of control beverage.
Experimental Study Product	Experimental Study Product	1 serving of a nutritional supplement for people with diabetes.

Primary Outcome Measures

Name	Time	Method
Hunger	Treatment Visit 1 and Treatment Visit 2	An appetite questionnaire evaluating change from baseline during each study visit.

Secondary Outcome Measures

Name	Time	Method
Prospective Consumption	Treatment Visit 1 and Treatment Visit 2	An appetite questionnaire evaluating change from baseline during each study visit.
Fullness	Treatment Visit 1 and Treatment Visit 2	An appetite questionnaire evaluating change from baseline during each study visit.
Desire to Eat	Treatment Visit 1 and Treatment Visit 2	An appetite questionnaire evaluating change from baseline during each study visit.

Trial Locations

Locations (2)

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States

Biofortis Clinical Research; 🇺🇸 Addison, Illinois, United States