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Study to Evaluate the Effects of Psyllium on Blood Glucose

NCT ID: NCT00888602

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Healthy Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MM1 - Meal

3.4g psyllium served with a meal

Group Type EXPERIMENTAL

3.4 g psyllium

Intervention Type DIETARY_SUPPLEMENT

3.4 g psyllium served with meal

MM2 - Meal

6.8 g psyllium served with a meal

Group Type EXPERIMENTAL

6.8 g psyllium

Intervention Type DIETARY_SUPPLEMENT

6.8 g psyllium served with a meal

MM2 (no Meal)

6.8 g psyllium consumed with no meal

Group Type EXPERIMENTAL

6.8 g psyllium

Intervention Type DIETARY_SUPPLEMENT

6.8 g psyllium

Meal Only

meal only

Group Type SHAM_COMPARATOR

Meal

Intervention Type OTHER

meal

Interventions

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3.4 g psyllium

3.4 g psyllium served with meal

Intervention Type DIETARY_SUPPLEMENT

6.8 g psyllium

6.8 g psyllium served with a meal

Intervention Type DIETARY_SUPPLEMENT

6.8 g psyllium

6.8 g psyllium

Intervention Type DIETARY_SUPPLEMENT

Meal

meal

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hill Top Research

Miamiville, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2009001

Identifier Type: -

Identifier Source: org_study_id