Appetite and Hunger, SuppressionPhase 3NCT01108328
Evaluation of Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX)
A Phase 3 study testing PolyGlycopleX (PGX) in people with Appetite and Hunger, Suppression and Blood Glucose, Postprandial, run by Canadian Center for Functional Medicine at 2 sites in Canada.
Trial summary
The objective of the study is to compare subjective appetite ratings and after-meal and 24 hour blood glucose levels within overweight and obese female subjects consuming either a standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX (treatment) or a rice flour (placebo control). Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite and Hunger, Suppression, Blood Glucose, Postprandial
- What is being tested?
- PolyGlycopleX (PGX)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2010to Nov 2010
- Phase
- Phase 3
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25-35 Kg/m2
Who cannot join
- Known diabetes
- Medications or natural health products that affect appetite
- Contraindications to LCD
- Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Canadian Centre for Functional Medicine
Coquitlam, British Columbia, V3K6Y2
Canadian Center for Functional Medicine
Coquitlam, British Columbia
About this study
Official title: A Prospective, Single Crossover, Randomized, Double Blind Placebo Controlled Trial Evaluating Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX) vs. Rice Flour Control, in Overweight and Moderately Obese Females.
The objective of the study is to compare subjective appetite ratings and after-meal and 24 hour blood glucose levels within overweight and obese female subjects consuming either a standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length and separated by 3 week washout phase, so subjects will also be acting as their own control. Subjects will be randomized to either start with the low calorie diet with PGX or the low calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour placebo control.
- Being tested
- PolyGlycopleX (PGX)
- Keywords
- viscous, fibre, polysaccharide, blood glucose, postprandial, appetite, hunger, satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyGlycopleX (PGX)Dietary supplement
powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days
| Study group | Role | What they receive |
|---|---|---|
| PolyGlycopleX (PGX) | Experimental | 5 grams of PGX 3 times per day with each main meal (breakfast, lunch and dinner) Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| Rice flour | Placebo comparator | 5 grams of rice flour 3 times per day at each main meal (breakfast, lunch and dinner) Receives: Dietary Supplement: PolyGlycopleX (PGX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.
Measured: 3 days
Secondary outcomes (1)
Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetite and Hunger, SuppressionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Center for Functional Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, InovoBiologic Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Lyon, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108328
- Sponsor's protocol ID
- PGX Crossover Study
- Status last verified
- Sep 2015
- First submitted
- 20 Apr 2010
- Last updated
- 2 Oct 2015
- Results posted
- No
Publications
Kacinik V, Lyon M, Purnama M, Reimer RA, Gahler R, Green TJ, Wood S. Effect of PGX, a novel functional fibre supplement, on subjective ratings of appetite in overweight and obese women consuming a 3-day structured, low-calorie diet. Nutr Diabetes. 2011 Dec 12;1(12):e22. doi: 10.1038/nutd.2011.18.
PubMed 23154443
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Crossover, Randomized, Double Blind Placebo Controlled Trial Evaluating Subjective Ratings of Appetite and Glucoregulation of a Low Calorie Diet Supplemented With a High Viscosity Polysaccharide (PolyGlycopleX - PGX) vs. Rice Flour Control, in Overweight and Moderately Obese Females.
- ClinicalTrials.gov ID
- NCT01108328
- Acronym / sponsor ID
- PGX Crossover Study
- Keywords
- viscous, fibre, polysaccharide, blood glucose, postprandial, appetite, hunger, satiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Canadian Center for Functional MedicineUniversity, hospital or other
- Collaborators
- University of British Columbia, InovoBiologic Inc.
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Apr 2010 (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 objective of the study is to compare subjective appetite ratings and after-meal and 24 hour blood glucose levels within overweight and obese female subjects consuming either a standardized 3 day low calorie diet supplemented with a viscous fibre known as PGX (treatment) or a rice flour (placebo control). Each treatment phase will be 3 days in length and separated by 3 week washout phase, so subjects will also be acting as their own control. Subjects will be randomized to either start with the low calorie diet with PGX or the low calorie diet supplemented with rice flour. We hypothesize that the 3 day LCD with PGX will elicit an improved appetite score compared to the 3 day LCD supplemented with the rice flour placebo control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PolyGlycopleX (PGX) | Experimental | Dietary Supplement: PolyGlycopleX (PGX)5 grams of PGX 3 times per day with each main meal (breakfast, lunch and dinner) |
| Rice flour | Placebo comparator | Dietary Supplement: PolyGlycopleX (PGX)5 grams of rice flour 3 times per day at each main meal (breakfast, lunch and dinner) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 25-35 Kg/m2
Key exclusion criteria (4 listed)
- Known diabetes
- Medications or natural health products that affect appetite
- Contraindications to LCD
- Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
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 |
|---|---|---|
| PolyGlycopleX (PGX)powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days | Dietary supplement | PolyGlycopleX (PGX), Rice flour |
Primary outcome
Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score.
Time frame: 3 days
1 secondary outcome
Changes in 2-hour postprandial areas under the curve (AUC) and 24 hour blood glucose (CGMS) profiles.
Time frame: 3 days
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 2 Oct 2015.
- Results publication: PubMed 23154443Kacinik V, Lyon M, Purnama M, Reimer RA, Gahler R, Green TJ, Wood S. Effect of PGX, a novel functional fibre supplement, on subjective ratings of appetite in overweight and obese women consuming a 3-day structured, low-calorie diet. Nutr Diabetes. 2011 Dec 12;1(12):e22. doi: 10.1038/nutd.2011.18.
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.
Michael Lyon, MD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PolyGlycopleX (PGX) in people with Appetite and Hunger, Suppression and Blood Glucose, Postprandial, run by Canadian Center for Functional Medicine at 2 sites in Canada.
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 1 inclusion and 4 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 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in the ratings of the variables in the Appetite Visual Analog Scale and the overall Appetite Score. (time frame: 3 days). 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 NCT01108328, which also lists 1 linked publication.
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 2 Oct 2015.