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CompletedNCT02641743Updated Dec 29, 2015

Clinical Trial for Liquid Food (Inslow)

An interventional study of Inslow and standard balanced formula in Diabetes, sponsored by Shanghai Meiji Health Science and Technology Co., Ltd.. Completed. Open to participants aged 52 Years to 61 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-29.

Sponsored by Shanghai Meiji Health Science and Technology Co., Ltd. · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
52 Years to 61 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Shanghai Meiji Health Science and Technology Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
52 Years to 61 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • These patients or subjects have no infectious diseases and were not using any drug.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Inslow

    Each participant was requested to consume one of is energetic test meals (200 kcal per serving 200ml) Inslow at 7:00 AM.

    Dietary Supplement: Inslow

  • 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.

    Dietary Supplement: standard balanced formula

Interventions

  • Dietary supplementInslow

    carbohydrate adjusted liquid food using palatinose as the major carbohydrate (\>50%)

  • Dietary supplementstandard balanced formula
06

What researchers measure

Primary outcomes

  1. plasma glucose concentration

    Time frame: 2 weeks

Secondary outcomes

  1. plasma insulin concentration

    Time frame: 2 weeks

  2. plasma free fatty acid concentration

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02641743
Lead sponsor
Shanghai Meiji Health Science and Technology Co., Ltd.
Responsible party
Sponsor
First posted
Dec 29, 2015
Start date
Jan 2009
Primary completion
Dec 2009
Completion
Feb 2010
Last update
Dec 29, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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