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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: conventional diabetic enteral drinks (Glucerna); Dietary Supplement: smoothie with regular formulas (SM); Dietary Supplement: smoothie with low carbohydrate formulas (SMLS)

• Registration Number: NCT04577274
• Lead Sponsor: Mahidol University

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).

Study Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-06
• Study Start: 2020-11-04
• Primary Completion: 2021-03-31
• Study Completion: 2021-05-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conventional diabetic enteral drinks (Glucerna)	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.
smoothie with regular formulas (SM)	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.
smoothie with low carbohydrate formulas (SMLS)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand