Impact of High Protein and Low Carbohydrate Smoothie Drinks in Type-2 Diabetes Mellitus

Study Overview
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Brief Summary
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We compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (Glucerna) on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals.

Detailed Description
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We aimed to determine the effect of high protein and low carbohydrate smoothie drinks on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals. We compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (Glucerna). A crossover design study was done in 60 diabetic participants. Participants consumed 300 kilocalories of each drink at a time with one week wash out period between drinks and glucose response curves at baseline, 30, 60, 90, 120, 180 and 240 minutes were monitored and compared. The products were formulated to supply 1 kilocalorie/milliliter (kcal/ml). Dietary compositions in regular formulas (smoothie, SM) were 30-40% carbohydrate, 20-30% protein and 30-50% fat. While in smoothie with low carbohydrate formulas (SMLS), they were 25-35% carbohydrate, 25-30% protein and 35-55% fat vs. a control formula (Glucerna).

Official Title
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Impact of High Protein and Low Carbohydrate Smoothie Drinks Versus Diabetes-specific Nutritional Formulas on Postprandial Glucose Homeostasis in Type-2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: smoothie with regular formulas (SM)
* Dietary Supplement: smoothie with low carbohydrate formulas (SMLS)
* Dietary Supplement: conventional diabetic enteral drinks (Glucerna)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people with type 2 diabetes mellitus or use blood glucose-lowering drugs more than 3 months BMI > 25 kg/m^2 HbA1c 6.5 - 8.5 use stable level of blood glucose-lowering drugs and blood lipid-lowering drugs more than 3 months Exclusion Criteria: pregnancy or breastfeeding people with chronic diseases or tube feeding or dysphagia i.e. pneumonia people with insulin injection or use GLP-1 analogues drugs or DPP-4 inhibitors drugs people with history of bariatric surgery, gastroparesis, malabsorption people with history of diseases that affect blood glucose/lipid control i.e. hyperthyroidism, endocrinology and kidney disorders use long-term immunosuppressants cancer patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smoothie with regular formulas (SM)<br>Participants were given 300 kcal smoothie with regular formulas within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. | Dietary Supplement: smoothie with regular formulas (SM)<br>* Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.<br>|
| Experimental: smoothie with low carbohydrate formulas (SMLS)<br>Participants were given 300 kcal smoothie with low carbohydrate formulas within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. | Dietary Supplement: smoothie with low carbohydrate formulas (SMLS)<br>* Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.<br>|
| Active Comparator: conventional diabetic enteral drinks (Glucerna)<br>Participants were given 300 kcal Glucerna within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. | Dietary Supplement: conventional diabetic enteral drinks (Glucerna)<br>* Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Glycemia at 240 minutes | glucose (mg/dl) | Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240 | 
| Change from baseline Insulin at 240 minutes | insulin (μU/ml) | Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | years | Baseline | 
| Weight | kg | Baseline | 
| Height | cm | Baseline | 
| Body Mass Index | kg/m^2 | Baseline | 
| Waist circumference | cm | Baseline | 
| Blood pressure | Systolic and Diastolic blood pressure (mmHg) | Baseline | 
| Complete Blood Count (CBC) | Red blood cells (RBC) [10^6 cells/ul], White blood cells (WBC) [10^3 cells/ul], Hemoglobin (HGB) [g/dL], Hematocrit (HCT) [%] | Baseline | 
| glycosylated hemoglobin (HbA1C) | percentage (%) | Baseline | 
| liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT) | Serum glutamate oxaloacetate transaminase (SGOT) [U/L] | Baseline | 
| liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT) | Serum glutamate pyruvate transaminase (SGPT) [U/L] | Baseline | 
| lipid profiles concentration analysis | Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-Cholesterol (mg/dl) and LDL-Cholesterol (mg/dl) | Baseline | 
| Creatinine concentration analysis | mg/dl | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical nutrition, smoothie drink, meal replacement, medical food, diabetes, obesity