- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02641743
Clinical Trial for Liquid Food (Inslow)
December 28, 2015 updated by: Shanghai Meiji Health Science and Technology Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
52 years to 61 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- These patients or subjects have no infectious diseases and were not using any drug.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inslow
Each participant was requested to consume one of is energetic test meals (200 kcal per serving 200ml) Inslow at 7:00 AM.
|
carbohydrate adjusted liquid food using palatinose as the major carbohydrate (>50%)
|
Placebo Comparator: standard balanced formula
Each participant was requested to consume one of is energetic test meals (200 kcal per serving 200ml) standard balanced formula at 7:00 AM.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma glucose concentration
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma insulin concentration
Time Frame: 2 weeks
|
2 weeks
|
plasma free fatty acid concentration
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
December 20, 2015
First Submitted That Met QC Criteria
December 28, 2015
First Posted (Estimate)
December 29, 2015
Study Record Updates
Last Update Posted (Estimate)
December 29, 2015
Last Update Submitted That Met QC Criteria
December 28, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 0001 (Cancer Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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