Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01163006
• Collaborator: Tate and Lyle Ingredients France (Industry)
• Enrollment: 60
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus; Obesity	Other: Polydextrose and soluble gluco fibre	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Official Title: Soluble Dietary Fibres as Dietetic Aid to Reduce the Risks of Type 2 Diabetes Mellitus
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: polydextrose	Other: Polydextrose and soluble gluco fibre; Polydextrose and soluble gluco fibre
Experimental: soluble glucofibre	Other: Polydextrose and soluble gluco fibre; Polydextrose and soluble gluco fibre
Placebo Comparator: isocaloric dietary control	Other: Polydextrose and soluble gluco fibre; Polydextrose and soluble gluco fibre
Placebo Comparator: full caloric control	Other: Polydextrose and soluble gluco fibre; Polydextrose and soluble gluco fibre

Outcome Measures

Primary Outcome Measures

1. fat oxidation []

Secondary Outcome Measures

1. 24h glucose pattern []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Overweight men and women

Exclusion Criteria:

• regular smokers, athletes, diabetes mellitus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University	Maastricht		Netherlands	6200 MD

Sponsors and Collaborators

• Maastricht University Medical Center
• Tate and Lyle Ingredients France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT01163006
• Other Study ID Numbers: MEC 09-3-084
• First Posted: Jul 15, 2010
• Last Update Posted: Jan 9, 2018
• Last Verified: Jul 1, 2010

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 9, 2018