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Study to Evaluate the Effects of Psyllium on Blood Glucose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888602
First Posted: April 27, 2009
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Procter and Gamble
  Purpose
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.

Condition Intervention
Healthy Men Dietary Supplement: 3.4 g psyllium Dietary Supplement: 6.8 g psyllium Other: Meal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: April 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: MM2 (no Meal)
6.8 g psyllium consumed with no meal
Dietary Supplement: 6.8 g psyllium
6.8 g psyllium
Sham Comparator: Meal Only
meal only
Other: Meal
meal

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888602


Locations
United States, Ohio
Hill Top Research
Miamiville, Ohio, United States, 45147
Sponsors and Collaborators
Procter and Gamble
  More Information

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00888602     History of Changes
Other Study ID Numbers: 2009001
First Submitted: April 24, 2009
First Posted: April 27, 2009
Last Update Posted: December 20, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals