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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- John McRorie, PhD, Study director, Procter and GambleMark Feinglos, MD, Principal investigator, Duke UniversityRichard Surwit, PhD, Principal investigator, Duke University
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
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.
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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?
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.