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Study to Evaluate the Effects of Psyllium on Blood Glucose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00888602
First received: April 24, 2009
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888602

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

No publications provided

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00888602     History of Changes
Other Study ID Numbers: 2009001
Study First Received: April 24, 2009
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
 Therapeutic Uses
Pharmacologic Actions
Antidiarrheals

ClinicalTrials.gov processed this record on June 18, 2013