NCT02641743

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

December 20, 2015

Last Update Submit

December 28, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • plasma glucose concentration

    2 weeks

Secondary Outcomes (2)

  • plasma insulin concentration

    2 weeks

  • plasma free fatty acid concentration

    2 weeks

Study Arms (2)

Inslow

EXPERIMENTAL

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

standard balanced formula

PLACEBO COMPARATOR

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

InslowDIETARY_SUPPLEMENT

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

Inslow
standard balanced formulaDIETARY_SUPPLEMENT
standard balanced formula

Eligibility Criteria

Age52 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2015

First Posted

December 29, 2015

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

December 29, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share