Comparison of Psyllium and Microcrystalline Cellulose on Glycemic Measures in Subjects With Impaired Fasting Glucose

Sponsor

Procter and Gamble (Industry)

Overall Status

Completed

CT.gov ID

NCT01549600

Collaborator

Duke University (Other)

Enrollment

Location

Arms

14.9

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Purpose of this study is to compare the effects of 2 types of dietary fiber, psyllium and microcrystalline cellulose (MCC), on glycemic measures in subjects with impaired fasting glucose.

Condition or Disease	Intervention/Treatment	Phase
Impaired Fasting Glucose	Dietary Supplement: psyllium Dietary Supplement: Microcrystalline Cellulose	N/A

Detailed Description

This study will be conducted at a single study center. Approximately 40 subjects with pre-type 2 diabetes will be enrolled and randomized in this study.

This 22-week study consists of 3 periods: an 8-week treatment period (Visits 2-4), a 6-week washout period, and an 8-week treatment period (Visits 5-7).

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Official Title:

A Randomized, Controlled Study To Compare the Effects of 2 Types of Dietary Fiber, Psyllium and Microcrystalline Cellulose, on Glycemic Measures in Subjects With Pre-type 2 Diabetes

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: psyllium 5.1 g psyllium husk in at least 8 ounces of water	Dietary Supplement: psyllium 1 level tablespoon (~ 5.1 g psyllium husk in the psyllium product) mixed with at least 8 ounces of water, taken twice daily
Active Comparator: Microcrsytalline Cellulose 1.18 g Microcrystalline Cellulose in at least 8 ounces of water, taken twice a day	Dietary Supplement: Microcrystalline Cellulose 1 level tablespoon (~ 1.18 g MCC in the MCC product) mixed with at least 8 ounces of water, taken twice a day

Arm

Intervention/Treatment

Experimental: psyllium

5.1 g psyllium husk in at least 8 ounces of water

Dietary Supplement: psyllium

1 level tablespoon (~ 5.1 g psyllium husk in the psyllium product) mixed with at least 8 ounces of water, taken twice daily

Active Comparator: Microcrsytalline Cellulose

1.18 g Microcrystalline Cellulose in at least 8 ounces of water, taken twice a day

Dietary Supplement: Microcrystalline Cellulose

1 level tablespoon (~ 1.18 g MCC in the MCC product) mixed with at least 8 ounces of water, taken twice a day

Outcome Measures

Primary Outcome Measures

fasting serum glucose [8 weeks]
mean change from baseline in fasting serum glucose at 8 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

be male or female,
at least 18 years of age
in generally good health for the pre-type 2 diabetes population;
if female, be postmenopausal or if of child-bearing capacity agree to use an adequate form of contraception
have not used any psyllium containing products within the past 3 months;
be willing to refrain from taking any psyllium containing products during the study;
be willing to maintain a lifestyle habits for the duration of the study;
have a fasting serum glucose of 110 - 125 mg/dL

Exclusion Criteria:

if female, are pregnant or nursing (lactating);
have a history of diabetes (diagnosis) or is currently taking medications for diabetes
participated in a clinical drug study or used investigational drug during the previous 30 days;
have symptoms and signs suggestive of significant underlying disease, or acute onset of new symptoms and signs of major organ disease, that could become unstable during the trial requiring urgent medical intervention
have evidence of or treatment history of malignancy within the previous 5 years;
currently alcohol dependent;
used anti-psychotics in the previous 3 months;
used systemic steroidal agents within the last 30 days;
had used oral or systemic antibiotics or any over-the-counter (OTC) bactericidal medication (eg, bismuth salts) within the last 30 days;
has been taking any medication that may affect blood glucose or GI motility (eg, calcium channel blockers, beta blockers, antimuscarinics, salicylates etc.) for less than 30 days or 5 times the half life of the drug (need to be stable on the medication);
have evidence of immunodeficiency including subjects currently taking systemic corticosteroids or immunosuppressive drugs
have a major psychiatric disorder, including major depression, psychoses, alcohol or substance abuse within the past 2 years;
has a known sensitivity or allergy to any components of study products, including psyllium and aspartame (see Section 3.5.3);
were previously screened (ie, Visit 1 procedures) for participation in this study and failed to meet entry criteria;
have difficulty swallowing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Procter and Gamble
Duke University

Investigators

Study Director: John McRorie, PhD, Procter and Gamble
Principal Investigator: Mark Feinglos, MD, Duke University
Principal Investigator: Richard Surwit, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Procter and Gamble

ClinicalTrials.gov Identifier:

NCT01549600

Other Study ID Numbers:

2011063

First Posted:

Mar 9, 2012

Last Update Posted:

Oct 28, 2014

Last Verified:

Apr 1, 2014

Additional relevant MeSH terms:

Psyllium

Study Results

No Results Posted as of Oct 28, 2014