Comparison of Psyllium and Microcrystalline Cellulose on Glycemic Measures in Subjects With Impaired Fasting Glucose
This study is ongoing, but not recruiting participants.
Sponsor:
Procter and Gamble
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
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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
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 June 17, 2013