Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

NCT02856516 | Completed

• 1 other identifier: 15.11.US.HCN
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Area under the blood glucose curve (AUC 0-240)

  Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary Outcomes (3)

• Area under the insulin curves (AUC 0-240)

  Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

• Insulinogenic index (Ins30/(Glu30)

  Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

• AUC (0-30min) for insulin

  Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Study Arms (3)

Boost Glucose Control (A)

EXPERIMENTAL

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

Other: Boost Glucose Control (A)

Boost Glucose Control (B)

EXPERIMENTAL

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

Other: Boost Glucose Control (B)

Boost Original

ACTIVE COMPARATOR

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption.

Other: Boost Original

Interventions

Boost Glucose Control (A) OTHER

Oral nutrition supplement

Boost Glucose Control (A)

Boost Glucose Control (B) OTHER

Oral nutrition supplement

Boost Glucose Control (B)

Boost Original OTHER

Oral nutrition supplement

Boost Original

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-75 yrs
• Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
• Hemoglobin A1C less than 9.0%
• Fasting blood glucose less than 180 mg

You may not qualify if:

• Abnormal thyroid function
• Creatinine \>2.0 mg/dL
• Potassium \<3.5 mEq/L
• Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
• Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
• Unable to give informed consent or follow instructions
• Current insulin therapy or insulin therapy within the past month
• Patients who are pregnant
• Allergies to milk, soy or any component of the test product
• Patient who in the Investigators assessment cannot be expected to comply with treatment
• Currently participating or having participated in another clinical trial.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joel Neutel, MD

  Orange County Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 5, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)