Impact of High Protein and Low Carbohydrate Smoothie Drinks in Type-2 Diabetes Mellitus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: smoothie with regular formulas (SM) 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)
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.
|
| Experimental: smoothie with low carbohydrate formulas (SMLS) 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)
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.
|
| Active Comparator: conventional diabetic enteral drinks (Glucerna) 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)
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Age [Baseline]
years
- Weight [Baseline]
kg
- 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) [%]
- glycosylated hemoglobin (HbA1C) [Baseline]
percentage (%)
- 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
Eligibility Criteria
Criteria
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:
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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
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people with history of bariatric surgery, gastroparesis, malabsorption
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people with history of diseases that affect blood glucose/lipid control i.e. hyperthyroidism, endocrinology and kidney disorders
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use long-term immunosuppressants
-
cancer patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok Noi | Bangkok | Thailand | 10700 |
Sponsors and Collaborators
- Mahidol University
- National Research Council of Thailand
Investigators
- Principal Investigator: Korapat Mayurasakorn, MD., Doctor in Family Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 814/2562 (IRB3)