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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Procter and Gamble.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT01549600
First received: March 6, 2012
Last updated: February 21, 2013
Last verified: October 2012
  Purpose

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 Intervention
Impaired Fasting Glucose
Dietary Supplement: psyllium
Dietary Supplement: Microcrystalline Cellulose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • fasting serum glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    mean change from baseline in fasting serum glucose at 8 weeks


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549600

Locations
United States, North Carolina
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
  More Information

No publications provided

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT01549600     History of Changes
Other Study ID Numbers: 2011063
Study First Received: March 6, 2012
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antidiarrheals

ClinicalTrials.gov processed this record on October 19, 2014