Diabetes Mellitus, Type 2
Conditions
Keywords
clinical nutrition, smoothie drink, meal replacement, medical food, diabetes, obesity
Brief summary
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
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).
Interventions
DIETARY_SUPPLEMENTsmoothie with regular formulas (SM)
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.
DIETARY_SUPPLEMENTsmoothie with low carbohydrate formulas (SMLS)
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.
DIETARY_SUPPLEMENTconventional diabetic enteral drinks (Glucerna)
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.
Sponsors
National Research Council of Thailand
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. people with type 2 diabetes mellitus or use blood glucose-lowering drugs more than 3 months 2. BMI \> 25 kg/m\^2 3. HbA1c 6.5 - 8.5 4. use stable level of blood glucose-lowering drugs and blood lipid-lowering drugs more than 3 months
Exclusion criteria
1. pregnancy or breastfeeding 2. people with chronic diseases or tube feeding or dysphagia i.e. pneumonia 3. people with insulin injection or use GLP-1 analogues drugs or DPP-4 inhibitors drugs 4. people with history of bariatric surgery, gastroparesis, malabsorption 5. people with history of diseases that affect blood glucose/lipid control i.e. hyperthyroidism, endocrinology and kidney disorders 6. use long-term immunosuppressants 7. cancer patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Glycemia at 240 minutes | Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240 | glucose (mg/dl) |
| Change from baseline Insulin at 240 minutes | Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240 | insulin (μU/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height | Baseline | cm |
| Body Mass Index | Baseline | kg/m\^2 |
| Waist circumference | Baseline | cm |
| Blood pressure | Baseline | Systolic and Diastolic blood pressure (mmHg) |
| Complete Blood Count (CBC) | Baseline | Red blood cells (RBC) \[10\^6 cells/ul\], White blood cells (WBC) \[10\^3 cells/ul\], Hemoglobin (HGB) \[g/dL\], Hematocrit (HCT) \[%\] |
| Age | Baseline | years |
| liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT) | Baseline | Serum glutamate oxaloacetate transaminase (SGOT) \[U/L\] |
| liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT) | Baseline | Serum glutamate pyruvate transaminase (SGPT) \[U/L\] |
| lipid profiles concentration analysis | Baseline | Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-Cholesterol (mg/dl) and LDL-Cholesterol (mg/dl) |
| Creatinine concentration analysis | Baseline | mg/dl |
| glycosylated hemoglobin (HbA1C) | Baseline | percentage (%) |
| Weight | Baseline | kg |
Countries
Thailand
Outcome results
None listed