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Study to Evaluate the Effects of Psyllium on Blood Glucose

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00888602
Enrollment
49
Registered
2009-04-27
Start date
2009-04-30
Completion date
2009-05-31
Last updated
2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Men

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.

Interventions

DIETARY_SUPPLEMENT3.4 g psyllium

3.4 g psyllium served with meal

DIETARY_SUPPLEMENT6.8 g psyllium

6.8 g psyllium served with a meal

OTHERMeal

meal

Sponsors

Procter and Gamble
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone4 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026