Diabetes Mellitus, Type 2NCT04577274
Impact of High Protein and Low Carbohydrate Smoothie Drinks in Type-2 Diabetes Mellitus
A study testing smoothie with regular formulas (SM), smoothie with low carbohydrate formulas (SMLS) and conventional diabetic enteral drinks (Glucerna) in people with Diabetes Mellitus, Type 2, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- smoothie with regular formulas (SM), smoothie with low carbohydrate formulas (SMLS) and conventional diabetic enteral drinks (Glucerna)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteThailand
- Study dates
- 4 Nov 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
About this study
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
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.
Read the 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).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- smoothie with regular formulas (SM), smoothie with low carbohydrate formulas (SMLS), conventional diabetic enteral drinks (Glucerna)
- Keywords
- clinical nutrition, smoothie drink, meal replacement, medical food, diabetes, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoothie with regular formulas (SM)Dietary supplement
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)Dietary supplement
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)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| smoothie with regular formulas (SM) | Experimental | 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. Receives: Dietary Supplement: smoothie with regular formulas (SM) |
| smoothie with low carbohydrate formulas (SMLS) | Experimental | 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. Receives: Dietary Supplement: smoothie with low carbohydrate formulas (SMLS) |
| conventional diabetic enteral drinks (Glucerna) | Active comparator | Participants were given 300 kcal Glucerna within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Receives: Dietary Supplement: conventional diabetic enteral drinks (Glucerna) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Glycemia at 240 minutes
glucose (mg/dl)
Measured: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
Change from baseline Insulin at 240 minutes
insulin (μU/ml)
Measured: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
Secondary outcomes (12)
Age
years
Measured: Baseline
Weight
kg
Measured: Baseline
Height
cm
Measured: Baseline
Body Mass Index
kg/m^2
Measured: Baseline
Waist circumference
cm
Measured: Baseline
Blood pressure
Systolic and Diastolic blood pressure (mmHg)
Measured: 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) [%]
Measured: Baseline
glycosylated hemoglobin (HbA1C)
percentage (%)
Measured: Baseline
liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT)
Serum glutamate oxaloacetate transaminase (SGOT) [U/L]
Measured: Baseline
liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT)
Serum glutamate pyruvate transaminase (SGPT) [U/L]
Measured: Baseline
lipid profiles concentration analysis
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-Cholesterol (mg/dl) and LDL-Cholesterol (mg/dl)
Measured: Baseline
Creatinine concentration analysis
mg/dl
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start4 Nov 2020
- Primary completion31 Mar 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Sponsor
- Investigators
- Korapat Mayurasakorn, MD., Principal investigator, Doctor in Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577274
- Sponsor's protocol ID
- 814/2562 (IRB3)
- Status last verified
- Apr 2022
- First submitted
- 1 Oct 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04577274
- Acronym / sponsor ID
- 814/2562 (IRB3)
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- clinical nutrition, smoothie drink, meal replacement, medical food, diabetes, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| smoothie with regular formulas (SM) | Experimental | Dietary Supplement: 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) | Experimental | Dietary Supplement: 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. |
| conventional diabetic enteral drinks (Glucerna) | Active comparator | Dietary Supplement: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | smoothie with regular formulas (SM) |
| 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. | Dietary supplement | smoothie with low carbohydrate formulas (SMLS) |
| 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. | Dietary supplement | conventional diabetic enteral drinks (Glucerna) |
Primary outcome
Change from baseline Glycemia at 240 minutes
Time frame: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
glucose (mg/dl)
Change from baseline Insulin at 240 minutes
Time frame: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
insulin (μU/ml)
12 secondary outcomes
Age
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Body Mass Index
Time frame: Baseline
Waist circumference
Time frame: Baseline
Blood pressure
Time frame: Baseline
Complete Blood Count (CBC)
Time frame: Baseline
glycosylated hemoglobin (HbA1C)
Time frame: Baseline
liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT)
Time frame: Baseline
liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT)
Time frame: Baseline
lipid profiles concentration analysis
Time frame: Baseline
Creatinine concentration analysis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Korapat Mayurasakorn, MD. principal investigator
Doctor in Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoothie with regular formulas (SM), smoothie with low carbohydrate formulas (SMLS) and conventional diabetic enteral drinks (Glucerna) in people with Diabetes Mellitus, Type 2, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Glycemia at 240 minutes (time frame: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.