NCT00888602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

1 month

First QC Date

April 24, 2009

Last Update Submit

December 19, 2012

Conditions

Healthy Men

Outcome Measures

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

    4 hours

Study Arms (4)

MM1 - Meal

EXPERIMENTAL

3.4g psyllium served with a meal

Dietary Supplement: 3.4 g psyllium

MM2 - Meal

EXPERIMENTAL

6.8 g psyllium served with a meal

Dietary Supplement: 6.8 g psyllium

MM2 (no Meal)

EXPERIMENTAL

6.8 g psyllium consumed with no meal

Dietary Supplement: 6.8 g psyllium

Meal Only

SHAM COMPARATOR

meal only

Other: Meal

Interventions

3.4 g psylliumDIETARY_SUPPLEMENT

3.4 g psyllium served with meal

MM1 - Meal
6.8 g psylliumDIETARY_SUPPLEMENT

6.8 g psyllium served with a meal

MM2 - Meal
MealOTHER

meal

Meal Only

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hill Top Research

Miamiville, Ohio, 45147, United States

Location

MeSH Terms

Interventions

PsylliumMeals

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

US(1)