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

NCT01549600 | Completed

• 1 other identifier: 2011063
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Fasting Glucose

Outcome Measures

Primary Outcomes (1)

• fasting serum glucose

  mean change from baseline in fasting serum glucose at 8 weeks

  8 weeks

Study Arms (2)

psyllium

EXPERIMENTAL

5.1 g psyllium husk in at least 8 ounces of water

Dietary Supplement: psyllium

Microcrsytalline Cellulose

ACTIVE COMPARATOR

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

Dietary Supplement: Microcrystalline Cellulose

Interventions

psyllium DIETARY_SUPPLEMENT

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

psyllium

Microcrystalline Cellulose DIETARY_SUPPLEMENT

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

Microcrsytalline Cellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Procter and Gamble: lead
• Duke University: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Psyllium; microcrystalline cellulose

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• John McRorie, PhD

  Procter and Gamble

  STUDY DIRECTOR

• Mark Feinglos, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Richard Surwit, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 28, 2014

Record last verified: 2014-04

Locations

US (1)