Study to Evaluate the Effects of Psyllium on Blood Glucose
Not Applicable
Completed
- Conditions
- Healthy Men
- Interventions
- Dietary Supplement: 3.4 g psylliumDietary Supplement: 6.8 g psylliumOther: Meal
- Registration Number
- NCT00888602
- Lead Sponsor
- Procter and Gamble
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 49
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MM1 - Meal 3.4 g psyllium 3.4g psyllium served with a meal MM2 - Meal 6.8 g psyllium 6.8 g psyllium served with a meal MM2 (no Meal) 6.8 g psyllium 6.8 g psyllium consumed with no meal Meal Only Meal meal only
- Primary Outcome Measures
Name Time Method to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone 4 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hill Top Research
🇺🇸Miamiville, Ohio, United States