Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2021-08-02
2021-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Active Comparator: Oral Nutrition Supplement Control
The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition.
Balance oral nutritional drink - control
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
Active Comparator: Oral Nutrition Supplement Test
The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes.
Balance oral nutritional drink - test
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
Interventions
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Balance oral nutritional drink - control
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
Balance oral nutritional drink - test
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg/dl
* Hematocrit levels within normal limits
* Having obtained his/her informed consent
Exclusion Criteria
* 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
* Patients with anemia
* Current insulin therapy or insulin therapy within the past month
* Patient 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
* Patients with anemia
* Currently participating in another clinical trial
20 Years
75 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Krysmaru Araujo Torres, MD
Role: STUDY_DIRECTOR
Nestle Health Science
Locations
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Orange County Research Center
Tustin, California, United States
Countries
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Other Identifiers
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21.04.US.HCN
Identifier Type: -
Identifier Source: org_study_id
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