Clinical trial NCT01549600: Comparison of Psyllium and Microcrystalline Cellulose on Glycemic Measures in Subjects With Impaired Fasting Glucose
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Fasting Glucose
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2012-03-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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 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

Primary outcomes:
measure: fasting serum glucose
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Procter and Gamble
name: John McRorie, PhD
role: STUDY_DIRECTOR
affiliation: Duke University
name: Mark Feinglos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Richard Surwit, PhD
role: PRINCIPAL_INVESTIGATOR
References: