Clinical Trial for Liquid Food (Inslow)

NCT ID: NCT02641743

Last Updated: 2015-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-02-28

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Inslow

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

Group Type: EXPERIMENTAL

Inslow

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

standard balanced formula

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Inslow

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

Intervention Type: DIETARY_SUPPLEMENT

standard balanced formula

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 52 Years
• Maximum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Meiji Health Science and Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id