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

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT01549600
First received: March 6, 2012
Last updated: October 27, 2014
Last verified: April 2014

March 6, 2012
October 27, 2014
February 2012
May 2013   (final data collection date for primary outcome measure)
fasting serum glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
mean change from baseline in fasting serum glucose at 8 weeks
Same as current
Complete list of historical versions of study NCT01549600 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Impaired Fasting Glucose
  • 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
  • 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
  • Experimental: psyllium
    5.1 g psyllium husk in at least 8 ounces of water
    Intervention: Dietary Supplement: psyllium
  • Active Comparator: Microcrsytalline Cellulose
    1.18 g Microcrystalline Cellulose in at least 8 ounces of water, taken twice a day
    Intervention: Dietary Supplement: Microcrystalline Cellulose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01549600
2011063
No
Procter and Gamble
Procter and Gamble
Duke University
Study Director: John McRorie, PhD Procter and Gamble
Principal Investigator: Mark Feinglos, MD Duke University
Principal Investigator: Richard Surwit, PhD Duke University
Procter and Gamble
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP