Soluble Dietary Fibres in the Prevention of Type 2 Diabet... | NCT01163006

Studies
Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

NCT01163006

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Jan 9, 2018Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus
Obesity

Interventions

Polydextrose and soluble gluco fibre

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jul 14, 2010

First Submission Date that Met QC Criteria

Jul 14, 2010

First Posted Date

Jul 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2018

Last Update Posted Date

Jan 9, 2018Actual

Name	Class
Tate and Lyle Ingredients France	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by using soluble dietary fibres) may reduce the glycemic or insulinemic response. This may in turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic profile in the longer term.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
polydextrose	Experimental	Other: Polydextrose and soluble gluco fibre
soluble glucofibre	Experimental	Other: Polydextrose and soluble gluco fibre
isocaloric dietary control	Placebo Comparator	Other: Polydextrose and soluble gluco fibre
full caloric control	Placebo Comparator	Other: Polydextrose and soluble gluco fibre

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polydextrose and soluble gluco fibre	Other	Polydextrose and soluble gluco fibre	full caloric control isocaloric dietary control polydextrose

Measure	Description	Time Frame
fat oxidation

Measure	Description	Time Frame
24h glucose pattern

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Overweight men and women

Exclusion Criteria:

regular smokers, athletes, diabetes mellitus

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht		6200 MD	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C033375	polydextrose

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided