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CompletedNCT00753181Updated Apr 27, 2009

Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes

A Phase 3 interventional study of Nutritional Formula and Usual diet in Diabetes Mellitus, Type 2, sponsored by Abbott Nutrition. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-04-27.

Sponsored by Abbott Nutrition · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. type 2 diabetes
  2. HbA1c >6.5% and \<11.0%
  3. male/non-pregnant, non-lactating female, at least 6 months postpartum
  4. if female of childbearing potential, practicing method of birth control
  5. Body Mass Index > 18.5 kg/m2 and \< 43.0 kg/m2.
  6. weight stable for past two months
  7. if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months

Exclusion criteria

Exclusion Criteria:

  1. uses injected medications (e.g., insulin, exenatide) for glucose control.
  2. history of diabetic ketoacidosis
  3. current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
  4. active malignancy
  5. states he/she has had a significant cardiovascular event \< 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
  6. end stage organ failure
  7. active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
  8. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
  9. use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.
  10. symptomatic in response to blood collection prior to enrollment into this study.
  11. clotting or bleeding disorders.
  12. non-typical eating pattern
  13. is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
  14. engages in strenuous exercise five or more times per week.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    A1

    Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake

    Other: Nutritional Formula

  • Active comparator
    A2

    Usual diet

    Other: Usual diet

  • Experimental
    A3

    Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars.

    Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.

Interventions

  • OtherNutritional Formula

    nutritional shake daily

  • OtherUsual diet

    usual dietary habits

  • OtherDiabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.

    nutritional shake, diabetes specific cereal and diabetes snack bar daily

06

What researchers measure

Primary outcomes

  1. Average daily blood glucose level

    Time frame: 11 days

Secondary outcomes

  1. Percentage of time in specified glucose ranges; Glycemic excursions; Change in plasma glucose, insulin, free fatty acids, triglycerides, 1,5-anhydroglucitol, and fructosamine; Dietary intake variables

    Time frame: 11 days

07

Study locations

2 sites
  • Provident Clinical Research
    Bloomington, Indiana 47403, United States
  • Radiant Research
    Cincinnati, Ohio 45242, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00753181
Lead sponsor
Abbott Nutrition
First posted
Sep 16, 2008
Start date
Aug 2008
Primary completion
Dec 2008
Completion
Mar 2009
Last update
Apr 27, 2009

Study contacts

Vikkie Mustad, PhD
study director · Abbott Nutrition

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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