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OpenTrials
Completed

NCT Number: NCT00888602

Study to Evaluate the Effects of Psyllium on Blood Glucose

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.

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Key information

Conditions

Healthy Men

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hill Top Research

Miamiville, Ohio, 45147, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3.4 g psyllium

Dietary Supplement

3.4 g psyllium served with meal

6.8 g psyllium

Dietary Supplement

6.8 g psyllium served with a meal

Meal

Other

meal

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2009
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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