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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: smoothie with regular formulas (SM); Dietary supplement: smoothie with low carbohydrate formulas (SMLS); Dietary supplement: conventional diabetic enteral drinks (Glucerna)

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
Body Mass Index	kg/m^2	Baseline
Height	cm	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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: National Research Council of Thailand

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2020
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (ACTUAL): October 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: diabetes; obesity; smoothie drink; meal replacement; medical food; clinical nutrition
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 814/2562 (IRB3)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No