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Post Prandial Glucose Control Proof-of-Principle

Post Prandial Glucose Control Proof-of-Principle

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01326299
Enrollment
50
Registered
2011-03-30
Start date
2010-08-31
Completion date
2010-09-30
Last updated
2011-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.

Interventions

OTHERCarbohydrate placebo

dissolve in water and consume with meal

OTHERNutritional ingredient

Dissolve in water and consume with meals

OTHER#1 Nutritional ingredient +Fiber

Dissolve in water and consume with meal

OTHER#2 Nutritional ingredient + Fiber

Dissolve in water and consume with meal

OTHER#3 Nutritional ingredient + Fiber

Dissolve in water and consume with meal

Sponsors

Abbott Nutrition
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. type 2 diabetes 2. between 21 and 75 years of age 3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile 4. BMI is \> 18.5 kg/m2 and \<35 kg/m2 5. HbA1c \< 9.0%

Exclusion criteria

1. Subject uses exogenous insulin, exenatide, or sitagliptin phosphate 2. type 1 diabetes. 3. history of diabetic ketoacidosis. 4. current infection 5. active malignancy 6. has had a significant cardiovascular event or history of congestive heart failure. 7. end-stage organ failure or post organ transplant. 8. history of renal disease. 9. hepatic disease. 10. history of gastrointestinal disorders 11. chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 12. taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications 13. clotting or bleeding disorders. 14. allergic or intolerant to any ingredient found in the study products.

Design outcomes

Primary

MeasureTime frame
Positive AUC from 0 to 240 minutes for plasma glucose.0 to 240 minutes

Secondary

MeasureTime frame
Plasma glucose concentrations0 to 240 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026