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

Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).

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

Study Overview

• Status: Withdrawn
• Conditions: Diabetes
• Intervention / Treatment: Other: Experimental Study Product; Other: Control Study Product

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Study Product; 1 serving of control beverage.	Other: Control Study Product; Other Names: Water beverage.
Experimental: Experimental Study Product; 1 serving of a nutritional supplement for people with diabetes.	Other: Experimental Study Product; Other Names: Oral nutritional supplement for people with Diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hunger	An appetite questionnaire evaluating change from baseline during each study visit.	Treatment Visit 1 and Treatment Visit 2

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 9, 2013

Study Record Updates

• Last Update Posted (Estimate): July 13, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: BL18