ObesityPhase 1NCT02134938
Effects of Viscous Fibre Containing Foods on Satiety (Gel Form)
A Phase 1 study testing Konjac Glucomannan in people with Obesity, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to assess whether low caloric, low energy density, konjac food products are effective in appetite regulation when administered as caloric replacements. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Konjac Glucomannan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Sep 2014
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking males and females
- Aged 18-70 years
- BMI between 18 - 29.9 kg/m²
- Non-dieters (1-10 score on Stunkard Eating Inventory)
Who cannot join
- Known reported history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, Celiac disease/gastrointestinal disease, or AIDS
- Weight change of +/- 3kg in the last 2 months
- Alcohol intake >2 drinks/day
- Inability to consume KJM-G meals
- Any condition which might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
- Non-compliance with experimental procedures or safety guidelines
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Clinical Risk Factor and Modification Centre
Toronto, Ontario, M5C 2T2
About this study
Official title: Effects of High-Fibre, Low-Energy Density Viscous Gel Meals on Satiety, Appetite Regulation and Subsequent Food Intake in Healthy Individuals
The purpose of this study is to assess whether low caloric, low energy density, konjac food products are effective in appetite regulation when administered as caloric replacements. It is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food products will have comparable satiety scores, decreased postprandial glucose response, and will not significantly affect subsequent food intake.
- Conditions
- Obesity
- Being tested
- Konjac Glucomannan
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Konjac GlucomannanDietary supplement
Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes
| Study group | Role | What they receive |
|---|---|---|
| Konjac Glucomannan | Experimental | 650g KJM-G Receives: Dietary Supplement: Konjac Glucomannan |
| Half Control/Half Konjac Glucomannan | Experimental | 325g KJM-G Receives: Dietary Supplement: Konjac Glucomannan |
| Control | No intervention | 0g KJM-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Satiety
Subjects will record their subjective satiety ratings using a 100 mm visual analogue scale and these ratings will be combined into a total subjective appetite score using the formula (Q1+Q2+(100-Q3)+Q4)/4.
Measured: 12 hours for each of the 3 study visits.
Secondary outcomes (6)
Ambulatory Blood Pressure
Measured: Measured at the beginning of each of the 3 study visits and every 30 minutes thereafter until 10:00pm the same day.
Height and Weight
Measured: Taken once at the beginning of each of the 3 clinical visits.
Blood Samples
Capillary blood samples will be collected in anticoagulant containing tubes stored at -20°C and analyzed by trained personnel for plasma glucose concentration using the glucose oxidase method by YSI 2300 STAT Plus within 48 hours.
Measured: One sample taken immediately prior to (0min) eating each meal (Breakfast, Lunch, Snack and Dinner) and at 30, 60, 90 and 120 min after eating the Breakfast and Lunch meals for each of the 3 study visits (total of 12 blood samples per study visit).
Palatability Scores
Measured: Measured immediately after eating and finishing (<15min after the first bite) each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.
Food Craving Rating
Subjects will record their subjective food craving ratings, if any, prior to each meal, using a 100mm visual analogue scale.
Measured: Rated immediately prior (0min) to eating each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.
Subsequent Food Intake
Subjects will record their subsequent food intake from 12h to 24h post first meal. Food record will be analyzed with The Nutrition Food Processor (ESHA) and data will be tabulated and included as part of the cumulative daily food intake.
Measured: Recorded from the 12th to the 24th hour after beginning the first meal (Breakfast at 0min) for each of the 3 study visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJul 2013
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Risk Factor Modification Centre - St. Michael's HospitalAlexandra Jenkins (Co-Investigator), RD, PhD, Principal investigator, Risk Factor Modification Centre - St. Michael's HospitalWilliam Watson (Qualified Investigator), MD, Principal investigator, Department of Family Medicine - St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134938
- Sponsor's protocol ID
- KJM-G
- Status last verified
- Apr 2014
- First submitted
- 14 Apr 2014
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Fibre, Low-Energy Density Viscous Gel Meals on Satiety, Appetite Regulation and Subsequent Food Intake in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02134938
- Acronym / sponsor ID
- KJM-G
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (estimated)
- First posted
- 9 May 2014 (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 assess whether low caloric, low energy density, konjac food products are effective in appetite regulation when administered as caloric replacements. It is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food products will have comparable satiety scores, decreased postprandial glucose response, and will not significantly affect subsequent food intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Konjac Glucomannan | Experimental | Dietary Supplement: Konjac Glucomannan650g KJM-G |
| Half Control/Half Konjac Glucomannan | Experimental | Dietary Supplement: Konjac Glucomannan325g KJM-G |
| Control | No intervention | –0g KJM-G |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy, non-smoking males and females
- Aged 18-70 years
- BMI between 18 - 29.9 kg/m²
- Non-dieters (1-10 score on Stunkard Eating Inventory)
Key exclusion criteria (6 listed)
- Known reported history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, Celiac disease/gastrointestinal disease, or AIDS
- Weight change of +/- 3kg in the last 2 months
- Alcohol intake >2 drinks/day
- Inability to consume KJM-G meals
- Any condition which might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
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 |
|---|---|---|
| Konjac GlucomannanKonjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes | Dietary supplement | Half Control/Half Konjac Glucomannan, Konjac Glucomannan |
Primary outcome
Subjective Satiety
Time frame: 12 hours for each of the 3 study visits.
Subjects will record their subjective satiety ratings using a 100 mm visual analogue scale and these ratings will be combined into a total subjective appetite score using the formula (Q1+Q2+(100-Q3)+Q4)/4.
6 secondary outcomes
Ambulatory Blood Pressure
Time frame: Measured at the beginning of each of the 3 study visits and every 30 minutes thereafter until 10:00pm the same day.
Height and Weight
Time frame: Taken once at the beginning of each of the 3 clinical visits.
Blood Samples
Time frame: One sample taken immediately prior to (0min) eating each meal (Breakfast, Lunch, Snack and Dinner) and at 30, 60, 90 and 120 min after eating the Breakfast and Lunch meals for each of the 3 study visits (total of 12 blood samples per study visit).
Palatability Scores
Time frame: Measured immediately after eating and finishing (<15min after the first bite) each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.
Food Craving Rating
Time frame: Rated immediately prior (0min) to eating each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.
Subsequent Food Intake
Time frame: Recorded from the 12th to the 24th hour after beginning the first meal (Breakfast at 0min) for each of the 3 study visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
Vladimir Vuksan, PhD principal investigator
Risk Factor Modification Centre - St. Michael's Hospital
Alexandra Jenkins (Co-Investigator), RD, PhD principal investigator
Risk Factor Modification Centre - St. Michael's Hospital
William Watson (Qualified Investigator), MD principal investigator
Department of Family Medicine - St. Michael's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Konjac Glucomannan in people with Obesity, run by Unity Health Toronto at 1 site 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 May 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodney Au-Yeung, BSc ((416) 864-6060 ext. 5526, auyeungf@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Satiety (time frame: 12 hours for each of the 3 study visits.). 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 9 May 2014.