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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
smoothie with regular formulas (SM)
smoothie with low carbohydrate formulas (SMLS)
conventional diabetic enteral drinks (Glucerna)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring clinical nutrition, smoothie drink, meal replacement, medical food, diabetes, obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

smoothie with regular formulas (SM)

smoothie with low carbohydrate formulas (SMLS)

conventional diabetic enteral drinks (Glucerna)

Arm Description

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.

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.

Participants were given 300 kcal Glucerna within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes.

Outcomes

Primary Outcome Measures

Change from baseline Glycemia at 240 minutes
glucose (mg/dl)
Change from baseline Insulin at 240 minutes
insulin (μU/ml)

Secondary Outcome Measures

Age
years
Weight
kg
Height
cm
Body Mass Index
kg/m^2
Waist circumference
cm
Blood pressure
Systolic and Diastolic blood pressure (mmHg)
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) [%]
glycosylated hemoglobin (HbA1C)
percentage (%)
liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT)
Serum glutamate oxaloacetate transaminase (SGOT) [U/L]
liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT)
Serum glutamate pyruvate transaminase (SGPT) [U/L]
lipid profiles concentration analysis
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-Cholesterol (mg/dl) and LDL-Cholesterol (mg/dl)
Creatinine concentration analysis
mg/dl

Full Information

First Posted
October 1, 2020
Last Updated
April 7, 2022
Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT04577274
Brief Title
Impact of High Protein and Low Carbohydrate Smoothie Drinks in Type-2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
National Research Council of Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
clinical nutrition, smoothie drink, meal replacement, medical food, diabetes, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
smoothie with regular formulas (SM)
Arm Type
Experimental
Arm Description
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.
Arm Title
smoothie with low carbohydrate formulas (SMLS)
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional diabetic enteral drinks (Glucerna)
Arm Type
Active Comparator
Arm Description
Participants were given 300 kcal Glucerna within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes.
Intervention Type
Dietary Supplement
Intervention Name(s)
smoothie with regular formulas (SM)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
smoothie with low carbohydrate formulas (SMLS)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
conventional diabetic enteral drinks (Glucerna)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Glycemia at 240 minutes
Description
glucose (mg/dl)
Time Frame
Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
Title
Change from baseline Insulin at 240 minutes
Description
insulin (μU/ml)
Time Frame
Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
Secondary Outcome Measure Information:
Title
Age
Description
years
Time Frame
Baseline
Title
Weight
Description
kg
Time Frame
Baseline
Title
Height
Description
cm
Time Frame
Baseline
Title
Body Mass Index
Description
kg/m^2
Time Frame
Baseline
Title
Waist circumference
Description
cm
Time Frame
Baseline
Title
Blood pressure
Description
Systolic and Diastolic blood pressure (mmHg)
Time Frame
Baseline
Title
Complete Blood Count (CBC)
Description
Red blood cells (RBC) [10^6 cells/ul], White blood cells (WBC) [10^3 cells/ul], Hemoglobin (HGB) [g/dL], Hematocrit (HCT) [%]
Time Frame
Baseline
Title
glycosylated hemoglobin (HbA1C)
Description
percentage (%)
Time Frame
Baseline
Title
liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT)
Description
Serum glutamate oxaloacetate transaminase (SGOT) [U/L]
Time Frame
Baseline
Title
liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT)
Description
Serum glutamate pyruvate transaminase (SGPT) [U/L]
Time Frame
Baseline
Title
lipid profiles concentration analysis
Description
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-Cholesterol (mg/dl) and LDL-Cholesterol (mg/dl)
Time Frame
Baseline
Title
Creatinine concentration analysis
Description
mg/dl
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 people with history of bariatric surgery, gastroparesis, malabsorption people with history of diseases that affect blood glucose/lipid control i.e. hyperthyroidism, endocrinology and kidney disorders use long-term immunosuppressants cancer patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korapat Mayurasakorn, MD.
Organizational Affiliation
Doctor in Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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

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