DiabetesNCT02641743
Clinical Trial for Liquid Food (Inslow)
A study testing Inslow and standard balanced formula in people with Diabetes, run by Shanghai Meiji Health Science and Technology Co., Ltd..
Trial summary
A carbohydrate adjusted liquid formula (Inslow) using palatinose as the major carbohydrate (>50%) was devised. Consumption Inslow for a long term (3-5 months) is reported to improve glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired glucose-tolerant subjects (IGT). Read more about this study
- Who is it for?
- Ages 52 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Inslow and standard balanced formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Feb 2010
- 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 52 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type 2 diabetes (symptoms of diabetes plus fasting plasma glucose level higher than 7.0 mmol/L and glucose levels after 75g oral glucose tolerance test (OGTT) or casual blood glucose level higher than 11.1mmol/L) and IGT patients (glucose levels after 75g OGTT between 7.8 and 11.1mmol/L).
Who cannot join
- These patients or subjects have no infectious diseases and were not using any drug.
About this study
Official title: Increased Insulinogenic Indexes Following Liquid Food (Inslow) Intake in Impaired Glucose Tolerance and Type-2 Diabetic Subjects.
A carbohydrate adjusted liquid formula (Inslow) using palatinose as the major carbohydrate (>50%) was devised. Consumption Inslow for a long term (3-5 months) is reported to improve glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired glucose-tolerant subjects (IGT). The present study intends to understand the mechanism on postprandial glycemic responses.
Read the detailed description
The test enteral nutrition formula (Inslow) and the standard balanced formula (Meibalance) were administered in a randomized crossover design to 11 healthy people, 13 IGT and 12 type-2 diabetes, judged by the postprandial state after in taking the two test meals in a random order with a washout period of one week. On the day prior to the test day, subjects were asked to stay at the same facility and to take the same supper with 450 kcal controlled, after 21:00 with only water allowed as ad libitum and not do any exercise. Each participant was taken a fasting blood sample, and then requested to consume one of is energetic test meals (200 kcal per serving) Inslow or standard balanced formula at 7:00 AM. Subsequent blood samples were collected at 30,60,90,and 120 min after meal consumption. The plasma concentrations of glucose, insulin, and free fatty acids were measured for each blood sample. Plasma glucose was measured by hexokinase method, plasma insulin by serum radioimmunoassay method and plasma free fatty acid by enzyme chemical method.Routine blood test and biochemical test were performed using the same blood sample only at fasting stage,including RBC, WBC, TP, ALP, T-Cho, etc., to confirm the status of each subject. Collected blood was applied to analyses at Shanghai Meizhong Clinical Measurement Centre. The enteral nutrition meal Inslow was designed by palatinose, dextrin and fiber as carbohydrate for 56%,23% and 15%, respectively. The standard balanced meal was included dextrin as the main carbohydrate for 85%, together with sugar and fiber.
- Conditions
- Diabetes
- Being tested
- Inslow, standard balanced formula
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InslowDietary supplement
carbohydrate adjusted liquid food using palatinose as the major carbohydrate (>50%)
standard balanced formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Inslow | Experimental | Each participant was requested to consume one of is energetic test meals (200 kcal per serving 200ml) Inslow at 7:00 AM. Receives: Dietary Supplement: Inslow |
| standard balanced formula | Placebo comparator | Each participant was requested to consume one of is energetic test meals (200 kcal per serving 200ml) standard balanced formula at 7:00 AM. Receives: Dietary Supplement: standard balanced formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma glucose concentration
Measured: 2 weeks
Secondary outcomes (2)
plasma insulin concentration
Measured: 2 weeks
plasma free fatty acid concentration
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Meiji Health Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641743
- Sponsor's protocol ID
- 0001
- Status last verified
- Dec 2015
- First submitted
- 20 Dec 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Insulinogenic Indexes Following Liquid Food (Inslow) Intake in Impaired Glucose Tolerance and Type-2 Diabetic Subjects.
- ClinicalTrials.gov ID
- NCT02641743
- Acronym / sponsor ID
- 0001
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shanghai Meiji Health Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Dec 2015 (estimated)
- 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.
A carbohydrate adjusted liquid formula (Inslow) using palatinose as the major carbohydrate (>50%) was devised. Consumption Inslow for a long term (3-5 months) is reported to improve glycemic control by reducing the postprandial plasma glucose levels in diabetes and impaired glucose-tolerant subjects (IGT). The present study intends to understand the mechanism on postprandial glycemic responses.
Detailed description
The test enteral nutrition formula (Inslow) and the standard balanced formula (Meibalance) were administered in a randomized crossover design to 11 healthy people, 13 IGT and 12 type-2 diabetes, judged by the postprandial state after in taking the two test meals in a random order with a washout period of one week. On the day prior to the test day, subjects were asked to stay at the same facility and to take the same supper with 450 kcal controlled, after 21:00 with only water allowed as ad libitum and not do any exercise. Each participant was taken a fasting blood sample, and then requested to consume one of is energetic test meals (200 kcal per serving) Inslow or standard balanced formula at 7:00 AM. Subsequent blood samples were collected at 30,60,90,and 120 min after meal consumption. The plasma concentrations of glucose, insulin, and free fatty acids were measured for each blood sample. Plasma glucose was measured by hexokinase method, plasma insulin by serum radioimmunoassay method and plasma free fatty acid by enzyme chemical method.Routine blood test and biochemical test were performed using the same blood sample only at fasting stage,including RBC, WBC, TP, ALP, T-Cho, etc., to confirm the status of each subject. Collected blood was applied to analyses at Shanghai Meizhong Clinical Measurement Centre. The enteral nutrition meal Inslow was designed by palatinose, dextrin and fiber as carbohydrate for 56%,23% and 15%, respectively. The standard balanced meal was included dextrin as the main carbohydrate for 85%, together with sugar and fiber.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inslow | Experimental | Dietary Supplement: InslowEach participant was requested to consume one of is energetic test meals (200 kcal per serving 200ml) Inslow at 7:00 AM. |
| standard balanced formula | Placebo comparator | Dietary Supplement: standard balanced formulaEach participant was requested to consume one of is energetic test meals (200 kcal per serving 200ml) standard balanced formula at 7:00 AM. |
Who may qualify
- Ages
- 52 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Type 2 diabetes (symptoms of diabetes plus fasting plasma glucose level higher than 7.0 mmol/L and glucose levels after 75g oral glucose tolerance test (OGTT) or casual blood glucose level higher than 11.1mmol/L) and IGT patients (glucose levels after 75g OGTT between 7.8 and 11.1mmol/L).
Key exclusion criteria (1 listed)
- These patients or subjects have no infectious diseases and were not using any drug.
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 |
|---|---|---|
| Inslowcarbohydrate adjusted liquid food using palatinose as the major carbohydrate (>50%) | Dietary supplement | Inslow |
| standard balanced formula | Dietary supplement | standard balanced formula |
Primary outcome
plasma glucose concentration
Time frame: 2 weeks
2 secondary outcomes
plasma insulin concentration
Time frame: 2 weeks
plasma free fatty acid concentration
Time frame: 2 weeks
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 29 Dec 2015.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inslow and standard balanced formula in people with Diabetes, run by Shanghai Meiji Health Science and Technology Co., Ltd..
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 1 inclusion and 1 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
plasma glucose concentration (time frame: 2 weeks). 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 29 Dec 2015.