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Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus, Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Polydextrose and soluble gluco fibre
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Overweight men and women

Exclusion Criteria:

  • regular smokers, athletes, diabetes mellitus

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

polydextrose

soluble glucofibre

isocaloric dietary control

full caloric control

Arm Description

Outcomes

Primary Outcome Measures

fat oxidation

Secondary Outcome Measures

24h glucose pattern

Full Information

First Posted
July 14, 2010
Last Updated
January 5, 2018
Sponsor
Maastricht University Medical Center
Collaborators
Tate and Lyle Ingredients France
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1. Study Identification

Unique Protocol Identification Number
NCT01163006
Brief Title
Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus
Official Title
Soluble Dietary Fibres as Dietetic Aid to Reduce the Risks of Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Tate and Lyle Ingredients France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Obesity

7. Study Design

Study Phase
Not Applicable
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
polydextrose
Arm Type
Experimental
Arm Title
soluble glucofibre
Arm Type
Experimental
Arm Title
isocaloric dietary control
Arm Type
Placebo Comparator
Arm Title
full caloric control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Polydextrose and soluble gluco fibre
Intervention Description
Polydextrose and soluble gluco fibre
Primary Outcome Measure Information:
Title
fat oxidation
Secondary Outcome Measure Information:
Title
24h glucose pattern

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Overweight men and women Exclusion Criteria: regular smokers, athletes, diabetes mellitus
Facility Information:
Facility Name
Maastricht University
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

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