NCT00935350

Brief Summary

Reductions of postprandial glucose levels have been demonstrated previously with the addition of a novel viscous polysaccharide (NVP) to a glucose drink and standard white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 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

May 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
Last Updated

July 9, 2009

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

March 25, 2009

Last Update Submit

July 8, 2009

Conditions

Keywords

viscousfibrepolysaccharideblood glucosepostprandial

Outcome Measures

Primary Outcomes (1)

  • Relative Blood glucose response of food with and without NVP

    Acute blood glucose response measured at 0, 15,30,45,60,90 and 120 min

Study Arms (15)

1

PLACEBO COMPARATOR

Control White bread containing 50g available carbohydrate

Dietary Supplement: PolyGlycopleX (PGX)

2

PLACEBO COMPARATOR

White bread and milk control

Dietary Supplement: PolyGlycopleX (PGX)

3

PLACEBO COMPARATOR

Granola control

Dietary Supplement: PolyGlycopleX (PGX)

4

PLACEBO COMPARATOR

Cornflakes and milk control

Dietary Supplement: PolyGlycopleX (PGX)

5

PLACEBO COMPARATOR

White rice control

Dietary Supplement: PolyGlycopleX (PGX)

6

PLACEBO COMPARATOR

Fruit yogurt control

Dietary Supplement: PolyGlycopleX (PGX)

7

PLACEBO COMPARATOR

Turkey dinner control

Dietary Supplement: PolyGlycopleX (PGX)

8

EXPERIMENTAL

Granola

Dietary Supplement: PolyGlycopleX (PGX)

9

EXPERIMENTAL

Cornflakes and milk

Dietary Supplement: PolyGlycopleX (PGX)

10

EXPERIMENTAL

White Rice

Dietary Supplement: PolyGlycopleX (PGX)

11

EXPERIMENTAL

Fruit yogurt

Dietary Supplement: PolyGlycopleX (PGX)

12

EXPERIMENTAL

Turkey dinner

Dietary Supplement: PolyGlycopleX (PGX)

13

PLACEBO COMPARATOR

White Bread

Dietary Supplement: PolyGlycopleX (PGX)

14

PLACEBO COMPARATOR

White bread

Dietary Supplement: PolyGlycopleX (PGX)

15

EXPERIMENTAL

Granola

Dietary Supplement: PolyGlycopleX (PGX)

Interventions

PolyGlycopleX (PGX)DIETARY_SUPPLEMENT

2.5 grams of PGX

158

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, Canada

Location

Related Publications (1)

  • Jenkins AL, Kacinik V, Lyon M, Wolever TM. Effect of adding the novel fiber, PGX(R), to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial. Nutr J. 2010 Nov 22;9:58. doi: 10.1186/1475-2891-9-58.

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
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2009

First Posted

July 9, 2009

Study Start

May 1, 2006

Primary Completion

June 1, 2006

Study Completion

August 1, 2006

Last Updated

July 9, 2009

Record last verified: 2009-07

Locations