NCT00801814

Brief Summary

To determine palatability and extent to which escalating doses of a novel highly viscous polysaccharide \[NVP\] reduces postprandial glycemia when added to a liquid and a solid meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2008

Completed
Last Updated

December 4, 2008

Status Verified

December 1, 2008

Enrollment Period

1 month

First QC Date

December 3, 2008

Last Update Submit

December 3, 2008

Conditions

Blood Glucose, Postprandial

Keywords

viscousfibrepolysaccharideblood glucosepost prandial

Outcome Measures

Primary Outcomes (1)

  • postprandial glycemia

    Acute study measuring postprandial glucose levels over 2 hours

Secondary Outcomes (1)

  • The glucose reduction index potential (GRIP). The GRIP factor is the reduction in glycemic index units per gram of fiber.

    Data analysis

Study Arms (6)

1

PLACEBO COMPARATOR

White Bread

Dietary Supplement: Control

2

PLACEBO COMPARATOR

White Bread and Margarine Control

Dietary Supplement: Second Control

3

PLACEBO COMPARATOR

Glucose drink control

Dietary Supplement: Control

4

EXPERIMENTAL

White bread and margarine or Glucose drink

Dietary Supplement: PolyGlycopleX (PGX)Dietary Supplement: PolyGlycopleX (PG)Dietary Supplement: PolyGlycopleX

5

EXPERIMENTAL

White bread and margarine or Glucose drink

Dietary Supplement: PolyGlycopleX (PGX)Dietary Supplement: PolyGlycopleX (PG)Dietary Supplement: PolyGlycopleX

6

EXPERIMENTAL

White bread and margarine or Glucose drink

Dietary Supplement: PolyGlycopleX (PGX)Dietary Supplement: PolyGlycopleX (PG)Dietary Supplement: PolyGlycopleX

Interventions

PolyGlycopleX (PGX)DIETARY_SUPPLEMENT

2.5 grams of PGX

456
PolyGlycopleX (PG)DIETARY_SUPPLEMENT

5.0 grams of PGX

456
PolyGlycopleXDIETARY_SUPPLEMENT

7.5 grams of PGX

456
ControlDIETARY_SUPPLEMENT

0g of PGX

13
Second ControlDIETARY_SUPPLEMENT

0g of PGX

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy individuals
  • years old
  • BMI less than 35 kg/m2

You may not qualify if:

  • Medications influencing gastrointestinal function
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2X3, Canada

Location

MeSH Terms

Interventions

PolyGlycoplex

Study Officials

  • Alexandra L Jenkins, PhD, RD

    Glycemic Index Laboratories, Inc

    STUDY DIRECTOR

  • Thomas MS Wolever, MD

    Glycemic Index Laboratories, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 4, 2008

Study Start

April 1, 2006

Primary Completion

May 1, 2006

Study Completion

August 1, 2006

Last Updated

December 4, 2008

Record last verified: 2008-12

Locations

CA(1)