NCT01163006

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 9, 2018

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

July 14, 2010

Last Update Submit

January 5, 2018

Conditions

Type 2 Diabetes MellitusObesity

Outcome Measures

Primary Outcomes (1)

  • fat oxidation

Secondary Outcomes (1)

  • 24h glucose pattern

Study Arms (4)

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

Polydextrose and soluble gluco fibreOTHER

Polydextrose and soluble gluco fibre

full caloric controlisocaloric dietary controlpolydextrosesoluble glucofibre

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight men and women

You may not qualify if:

  • regular smokers, athletes, diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

polydextrose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 9, 2018

Record last verified: 2010-07

Locations

NL(1)