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Completed

NCT Number: NCT02641743

Clinical Trial for Liquid Food (Inslow)

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.

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Key information

Age range

52 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inslow

Dietary Supplement

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

standard balanced formula

Dietary Supplement

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

Sponsors and collaborators

Lead sponsor

Shanghai Meiji Health Science and Technology Co., Ltd.

Industry

Registry information

Official study title

Increased Insulinogenic Indexes Following Liquid Food (Inslow) Intake in Impaired Glucose Tolerance and Type-2 Diabetic Subjects.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Dec 29, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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