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
14 participants
INTERVENTIONAL
2020-05-18
2020-08-11
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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Balanced Nutritional Drink
The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.
Balanced Nutritional Drink
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.
Balanced Nutritional Drink - DMA
The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.
Diabetes Specific, Balanced Nutritional Drink (DMA)
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 available in retail setting.
Balanced Nutritional Drink - DMB
The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.
Diabetes Specific, Balanced Nutritional Drink DMB
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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Balanced Nutritional Drink
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.
Diabetes Specific, Balanced Nutritional Drink (DMA)
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 available in retail setting.
Diabetes Specific, Balanced Nutritional Drink DMB
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
* 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
* Unable to give informed consent or follow instructions
* 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
* Currently participating or having participated in another clinical trial
* Patients with anemia
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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19.01.US.HCN
Identifier Type: -
Identifier Source: org_study_id
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