Study to Evaluate the Effects of Psyllium on Blood Glucose

Healthy Men Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888602
• Other study ID #: 2009001
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: December 19, 2012
• Start date: April 2009
• Est. completion date: May 2009

Study information

• Verified date: December 2012
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Men

Intervention

Dietary Supplement:
• 3.4 g psyllium
3.4 g psyllium served with meal
• 6.8 g psyllium
6.8 g psyllium served with a meal
• 6.8 g psyllium
6.8 g psyllium

Other:
• Meal
meal

Locations

Country	Name	City	State
United States	Hill Top Research	Miamiville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No