Clinical Trial for Liquid Food (Inslow)

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: Diabetes
• Intervention / Treatment: Dietary supplement: Inslow; Dietary supplement: standard balanced formula

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

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

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.	Dietary supplement: Inslow; 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.	Dietary supplement: standard balanced formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
plasma glucose concentration	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
plasma insulin concentration	2 weeks
plasma free fatty acid concentration	2 weeks

Collaborators and Investigators

• Sponsor: Shanghai Meiji Health Science and Technology Co., Ltd.

Study record dates

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