Clinical Trial for Liquid Food (Inslow)

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Diabetes

Clinical Trial Details

NCT number	NCT02641743
Study type	Interventional
Source	Shanghai Meiji Health Science and Technology Co., Ltd.
Contact
Status	Completed
Phase	N/A
Start date	January 2009
Completion date	February 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05594446` - Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
Completed	`NCT03975309` - DHS MIND Metabolomics
Completed	`NCT01855399` - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes	N/A
Completed	`NCT01819129` - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes	Phase 3
Recruiting	`NCT04984226` - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD	Phase 2
Recruiting	`NCT05007990` - Caregiving Networks Across Disease Context and the Life Course
Active, not recruiting	`NCT04420936` - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program	N/A
Recruiting	`NCT03549559` - Imaging Histone Deacetylase in the Heart	N/A
Completed	`NCT04903496` - Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Completed	`NCT01437592` - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects	Phase 1
Completed	`NCT01696266` - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed	`NCT04082585` - Total Health Improvement Program Research Project
Completed	`NCT03390179` - Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Not yet recruiting	`NCT05029804` - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes	N/A
Recruiting	`NCT05294822` - Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes	N/A
Completed	`NCT04427982` - Dance and Diabetes/Prediabetes Self-Management	N/A
Completed	`NCT02356848` - STEP UP to Avert Amputation in Diabetes	N/A
Completed	`NCT03292185` - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects	Phase 1
Active, not recruiting	`NCT05477368` - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes	N/A
Completed	`NCT04496401` - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.