Impaired Fasting GlucoseNCT01549600

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

A study testing psyllium and Microcrystalline Cellulose in people with Impaired Fasting Glucose, run by Procter and Gamble at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Impaired Fasting Glucose
What is being tested?: psyllium and Microcrystalline Cellulose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Feb 2012to May 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

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

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.

Read the 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).

Conditions: Impaired Fasting Glucose
Being tested: psyllium, Microcrystalline Cellulose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

psylliumDietary supplement
1 level tablespoon (~ 5.1 g psyllium husk in the psyllium product) mixed with at least 8 ounces of water, taken twice daily
Microcrystalline CelluloseDietary supplement
1 level tablespoon (~ 1.18 g MCC in the MCC product) mixed with at least 8 ounces of water, taken twice a day

Study groups in NCT01549600
Study group	Role	What they receive
psyllium	Experimental	5.1 g psyllium husk in at least 8 ounces of water Receives: Dietary Supplement: psyllium
Microcrsytalline Cellulose	Active comparator	1.18 g Microcrystalline Cellulose in at least 8 ounces of water, taken twice a day Receives: Dietary Supplement: Microcrystalline Cellulose

What is being measured

The primary outcome is the main question the study is designed to answer.

fasting serum glucose
mean change from baseline in fasting serum glucose at 8 weeks
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012May 2013

First posted9 Mar 2012 (estimated)
Study startFeb 2012
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Impaired Fasting GlucoseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01549600
Sponsor's protocol ID: 2011063
Status last verified: Apr 2014
First submitted: 6 Mar 2012
Last updated: 28 Oct 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Impaired Fasting Glucose trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01549600
Acronym / sponsor ID: 2011063
Conditions: Impaired Fasting Glucose
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Procter and GambleIndustry (pharma, biotech, devices)
Collaborators: Duke University
Study start: Feb 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 9 Mar 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
psyllium	Experimental	Dietary Supplement: psyllium5.1 g psyllium husk in at least 8 ounces of water
Microcrsytalline Cellulose	Active comparator	Dietary Supplement: Microcrystalline Cellulose1.18 g Microcrystalline Cellulose in at least 8 ounces of water, taken twice a day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
psyllium1 level tablespoon (~ 5.1 g psyllium husk in the psyllium product) mixed with at least 8 ounces of water, taken twice daily	Dietary supplement	psyllium
Microcrystalline Cellulose1 level tablespoon (~ 1.18 g MCC in the MCC product) mixed with at least 8 ounces of water, taken twice a day	Dietary supplement	Microcrsytalline Cellulose

Primary outcome

fasting serum glucose
Time frame: 8 weeks
mean change from baseline in fasting serum glucose at 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.

Related trials for Impaired Fasting Glucose

Active, not recruitingPhase 2
Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.
PreDiabetes, Impaired Glucose Tolerance
Not yet recruitingObservational study
Multimodal Risk Factor Graph Mapping, Metabolic Subtyping, and Digital Intelligent Chronic Disease Management for Prediabetes: An Integrated Cohort and Case-Control Clinical Study
Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Recruiting
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
Diabetes Mellitus, Type 2, Impaired Glucose Tolerance (IGT)
Not yet recruitingObservational study
Growth Hormone Resistance of Beta-cells
Healthy, Obesity & Overweight
Not yet recruiting
Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control
Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John McRorie, PhD study director

Procter and Gamble

Mark Feinglos, MD principal investigator

Duke University

Richard Surwit, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing psyllium and Microcrystalline Cellulose in people with Impaired Fasting Glucose, run by Procter and Gamble at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fasting serum glucose (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01549600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.