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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577274
• Other study ID #: 814/2562 (IRB3)
• Status: Completed
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Glycemia at 240 minutes	glucose (mg/dl)	Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
Primary	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	Age	years	Baseline
Secondary	Weight	kg	Baseline
Secondary	Height	cm	Baseline
Secondary	Body Mass Index	kg/m^2	Baseline
Secondary	Waist circumference	cm	Baseline
Secondary	Blood pressure	Systolic and Diastolic blood pressure (mmHg)	Baseline
Secondary	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
Secondary	glycosylated hemoglobin (HbA1C)	percentage (%)	Baseline
Secondary	liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT)	Serum glutamate oxaloacetate transaminase (SGOT) [U/L]	Baseline
Secondary	liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT)	Serum glutamate pyruvate transaminase (SGPT) [U/L]	Baseline
Secondary	lipid profiles concentration analysis	Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-Cholesterol (mg/dl) and LDL-Cholesterol (mg/dl)	Baseline
Secondary	Creatinine concentration analysis	mg/dl	Baseline