NCT00888602
Completed
Not Applicable
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
Procter and Gamble1 site in 1 country49 target enrollmentApril 2009
ConditionsHealthy Men
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Men
- Sponsor
- Procter and Gamble
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Study Sites (1)
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