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

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

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.

Study Overview

• Status: Completed
• Conditions: Impaired Fasting Glucose
• Intervention / Treatment: Dietary supplement: psyllium; Dietary supplement: Microcrystalline Cellulose

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting serum glucose	mean change from baseline in fasting serum glucose at 8 weeks	8 weeks

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Collaborators: 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 record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Psyllium
• Other Study ID Numbers: 2011063