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

Impaired Fasting Glucose Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549600
• Other study ID #: 2011063
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: October 27, 2014
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: April 2014
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Impaired Fasting Glucose
• Prediabetic State

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Procter and Gamble	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting serum glucose	mean change from baseline in fasting serum glucose at 8 weeks	8 weeks	No