Study to Evaluate the Effects of Psyllium on Blood Glucose
Status
Completed
Conditions
Healthy Men
Treatments
Dietary Supplement: 3.4 g psyllium
Other: Meal
Dietary Supplement: 6.8 g psyllium
Details and patient eligibility
About
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.
Enrollment
49 patients
Sex
Male
Ages
18 to 50 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
49 participants in 4 patient groups
MM1 - Meal
Experimental group
Description:
3.4g psyllium served with a meal
Treatment:
Dietary Supplement: 3.4 g psyllium
MM2 - Meal
Experimental group
Description:
6.8 g psyllium served with a meal
Treatment:
Dietary Supplement: 6.8 g psyllium
Dietary Supplement: 6.8 g psyllium
MM2 (no Meal)
Experimental group
Description:
6.8 g psyllium consumed with no meal
Treatment:
Dietary Supplement: 6.8 g psyllium
Dietary Supplement: 6.8 g psyllium
Meal Only
Sham Comparator group
Description:
meal only
Treatment:
Other: Meal
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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