Healthy MenNCT00888602
Study to Evaluate the Effects of Psyllium on Blood Glucose
A study testing 3.4 g psyllium, 6.8 g psyllium and Meal in people with Healthy Men, run by Procter and Gamble at 1 site in United States.
Trial summary
This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- 3.4 g psyllium, 6.8 g psyllium and Meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2009
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- 18 to 50 years of age
- general good health
- Body Mass Index (BMI) in the range of 18.5-29.9 kg/m2
- fasting plasma blood glucose <126mg/dL
- not actively treated for high blood glucose
- willing and able to have blood drawn at multiple times during each 4 visits
Who cannot join
- history of allergy or hypersensitivity to inhaled or ingested psyllium or meal ingredients
- Phenylketonuria (PKU)
- an eating disorder
- following special medical or weight-loss dietary restrictions
- taking dietary supplements or prescription medication for the purpose of weight loss/management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, 4-Period Cross-over Study to Evaluate the Effects of Psyllium Taken Before a Meal on Postprandial Blood Glucose in Healthy Males
This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures.
- Conditions
- Healthy Men
- Being tested
- 3.4 g psyllium, 6.8 g psyllium, Meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.4 g psylliumDietary supplement
3.4 g psyllium served with meal
6.8 g psylliumDietary supplement
6.8 g psyllium served with a meal
6.8 g psylliumDietary supplement
6.8 g psyllium
MealOther
meal
| Study group | Role | What they receive |
|---|---|---|
| MM1 - Meal | Experimental | 3.4g psyllium served with a meal Receives: Dietary Supplement: 3.4 g psyllium |
| MM2 - Meal | Experimental | 6.8 g psyllium served with a meal Receives: Dietary Supplement: 6.8 g psyllium |
| MM2 (no Meal) | Experimental | 6.8 g psyllium consumed with no meal Receives: Dietary Supplement: 6.8 g psyllium |
| Meal Only | Sham comparator | meal only Receives: Other: Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies 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
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888602
- Sponsor's protocol ID
- 2009001
- Status last verified
- Dec 2012
- First submitted
- 24 Apr 2009
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, 4-Period Cross-over Study to Evaluate the Effects of Psyllium Taken Before a Meal on Postprandial Blood Glucose in Healthy Males
- ClinicalTrials.gov ID
- NCT00888602
- Acronym / sponsor ID
- 2009001
- Conditions
- Healthy Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Apr 2009 (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.
This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MM1 - Meal | Experimental | Dietary Supplement: 3.4 g psyllium3.4g psyllium served with a meal |
| MM2 - Meal | Experimental | Dietary Supplement: 6.8 g psyllium6.8 g psyllium served with a meal |
| MM2 (no Meal) | Experimental | Dietary Supplement: 6.8 g psyllium6.8 g psyllium consumed with no meal |
| Meal Only | Sham comparator | Other: Mealmeal only |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- male
- 18 to 50 years of age
- general good health
- Body Mass Index (BMI) in the range of 18.5-29.9 kg/m2
- fasting plasma blood glucose <126mg/dL
Key exclusion criteria (5 listed)
- history of allergy or hypersensitivity to inhaled or ingested psyllium or meal ingredients
- Phenylketonuria (PKU)
- an eating disorder
- following special medical or weight-loss dietary restrictions
- taking dietary supplements or prescription medication for the purpose of weight loss/management
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 |
|---|---|---|
| 3.4 g psyllium3.4 g psyllium served with meal | Dietary supplement | MM1 - Meal |
| 6.8 g psyllium6.8 g psyllium served with a meal | Dietary supplement | MM2 - Meal |
| 6.8 g psyllium6.8 g psyllium | Dietary supplement | MM2 (no Meal) |
| Mealmeal | Other | Meal Only |
Primary outcome
to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone
Time frame: 4 hours
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 20 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3.4 g psyllium, 6.8 g psyllium and Meal in people with Healthy Men, 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 7 inclusion and 5 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 20 Dec 2012. 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. Some participants in this study may receive a placebo. 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?
to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone (time frame: 4 hours). 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 20 Dec 2012.