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
  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:


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
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, see Learn About Clinical Studies.

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 July 23, 2014