Study to Evaluate the Effects of Psyllium on Blood Glucose | NCT00888602

Studies
Study to Evaluate the Effects of Psyllium on Blood Glucose

NCT00888602

Sponsor

Procter and Gamble

Status

Completed

Last Update Posted

Dec 20, 2012Estimated

Enrollment

49Actual

Phase

Not Applicable

Conditions

Healthy Men

Interventions

3.4 g psyllium
6.8 g psyllium
6.8 g psyllium
Meal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Apr 24, 2009

First Submission Date that Met QC Criteria

Apr 24, 2009

First Posted Date

Apr 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2012

Last Update Posted Date

Dec 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MM1 - Meal	Experimental	3.4g psyllium served with a meal	Dietary Supplement: 3.4 g psyllium
MM2 - Meal	Experimental	6.8 g psyllium served with a meal	Dietary Supplement: 6.8 g psyllium
MM2 (no Meal)	Experimental	6.8 g psyllium consumed with no meal	Dietary Supplement: 6.8 g psyllium
Meal Only	Sham Comparator	meal only	Other: Meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3.4 g psyllium	Dietary Supplement	3.4 g psyllium served with meal	MM1 - Meal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone		4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male
18 to 50 years of age
general good health
Body Mass Index (BMI) in the range of 18.5-29.9 kg/m2
fasting plasma blood glucose <126mg/dL
not actively treated for high blood glucose
willing and able to have blood drawn at multiple times during each 4 visits

Exclusion Criteria:

history of allergy or hypersensitivity to inhaled or ingested psyllium or meal ingredients
Phenylketonuria (PKU)
an eating disorder
following special medical or weight-loss dietary restrictions
taking dietary supplements or prescription medication for the purpose of weight loss/management

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hill Top Research		Miamiville	Ohio	45147	United States

Intervention Browse Module

MeSH Terms

ID	Term
D011620	Psyllium
D062407	Meals

Ancestor Terms

ID	Term
D010936	Plant Extracts
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided