Study to Evaluate the Effects of Psyllium on Blood Glucose

December 19, 2012 updated by: Procter and Gamble

An Open Label, Randomized, 4-Period Cross-over Study to Evaluate the Effects of Psyllium Taken Before a Meal on Postprandial Blood Glucose in Healthy Males

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Miamiville, Ohio, United States, 45147
        • Hill Top Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MM1 - Meal
3.4g psyllium served with a meal
Dietary supplement: 3.4 g psyllium
3.4 g psyllium served with meal
Experimental: MM2 - Meal
6.8 g psyllium served with a meal
Dietary supplement: 6.8 g psyllium
6.8 g psyllium served with a meal
Dietary supplement: 6.8 g psyllium
6.8 g psyllium
Experimental: MM2 (no Meal)
6.8 g psyllium consumed with no meal
Dietary supplement: 6.8 g psyllium
6.8 g psyllium served with a meal
Dietary supplement: 6.8 g psyllium
6.8 g psyllium
Sham Comparator: Meal Only
meal only
Other: Meal
meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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