Study to Evaluate the Effects of Psyllium on Blood Glucose

Procter and Gamble49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Men

Interventions

3.4 g psylliumDIETARY_SUPPLEMENT

3.4 g psyllium served with meal

6.8 g psylliumDIETARY_SUPPLEMENT

6.8 g psyllium served with a meal

6.8 g psylliumDIETARY_SUPPLEMENT

6.8 g psyllium

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hill Top Research

Miamiville, Ohio, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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