Appetite SuppressionPhase 3NCT01109199
Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight
A Phase 3 study testing PolyGlycopleX (PGX) and Rice flour in people with Appetite Suppression and Weight Loss, run by Canadian Center for Functional Medicine at 2 sites in Canada.
Trial summary
This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite Suppression, Weight Loss
- What is being tested?
- PolyGlycopleX (PGX) and Rice flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2010to Apr 2011
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25 - 35 Kg/m2
Who cannot join
- Medications and supplements that affect appetite
- Known diabetes
- 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 Center for Functional Medicine
Coquitlam, British Columbia, V3K 6Y7
Canadian Center for Functional Medicine
Coquitlam, British Columbia
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre (PGX) Supplementation of a Low Calorie Diet on Appetite and Body Weight, in Overweight and Moderately Obese Females
This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female.
The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a 14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the rice flour supplementation of the LCD.
- Conditions
- Appetite Suppression, Weight Loss
- Being tested
- PolyGlycopleX (PGX), Rice flour
- Keywords
- viscous, fibre, polysaccharide, appetite, hunger, satiety, weight management
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyGlycopleX (PGX)Dietary supplement
The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
Rice flourDietary supplement
The full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
| Study group | Role | What they receive |
|---|---|---|
| PolyGlycopleX (PGX) | Experimental | Not described Receives: Dietary Supplement: PolyGlycopleX (PGX) |
| Rice Flour | Placebo comparator | Not described Receives: Dietary Supplement: Rice flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in appetite score assessed from appetite Visual Analog Scale
Measured: 18 weeks
Secondary outcomes (2)
Change in weight (kilograms)
Measured: 18 weeks
Change in percentage of body fat
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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 R Lyon, M.D., Principal investigator, Canadian Center for Functional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109199
- Sponsor's protocol ID
- PGX RCT Study
- Status last verified
- Sep 2015
- First submitted
- 20 Apr 2010
- Last updated
- 2 Oct 2015
- Results posted
- No
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 Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre (PGX) Supplementation of a Low Calorie Diet on Appetite and Body Weight, in Overweight and Moderately Obese Females
- ClinicalTrials.gov ID
- NCT01109199
- Acronym / sponsor ID
- PGX RCT Study
- Conditions
- Appetite Suppression, Weight Loss
- Keywords
- viscous, fibre, polysaccharide, appetite, hunger, satiety, weight management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Canadian Center for Functional MedicineUniversity, hospital or other
- Collaborators
- University of British Columbia, InovoBiologic Inc.
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 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.
This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female.
The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a 14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the rice flour supplementation of the LCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PolyGlycopleX (PGX) | Experimental | Dietary Supplement: PolyGlycopleX (PGX) |
| Rice Flour | Placebo comparator | Dietary Supplement: Rice flour |
Who may qualify
- Ages
- 20 to 55 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)
- Medications and supplements that affect appetite
- Known diabetes
- 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)The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day. | Dietary supplement | PolyGlycopleX (PGX) |
| Rice flourThe full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day. | Dietary supplement | Rice Flour |
Primary outcome
The difference in appetite score assessed from appetite Visual Analog Scale
Time frame: 18 weeks
2 secondary outcomes
Change in weight (kilograms)
Time frame: 18 weeks
Change in percentage of body fat
Time frame: 18 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 2 Oct 2015.
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 R Lyon, M.D. principal investigator
Canadian Center for Functional Medicine
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) and Rice flour in people with Appetite Suppression and Weight Loss, 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?
The difference in appetite score assessed from appetite Visual Analog Scale (time frame: 18 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 2 Oct 2015.