ObesityPhase 1InGelNCT01875627
Satiety Study of a Carbohydrate Meal to a Highly Viscous Gel Meal
A Phase 1 study testing Konjac noodles, Carbohydrate and Konjac Noodles and Carbohydrate noodles in people with Obesity, run by Unity Health Toronto at 1 site in Canada.
Trial summary
To evaluate the effects of Konjac on satiety and subsequent food intake in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Konjac noodles, Carbohydrate and Konjac Noodles and Carbohydrate noodles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Jan 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Age 18-65 years
- Having a BMI of 18.5 - 25 kg/m2
- No presence of major disease
Who cannot join
- Known history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, gastrointestinal disease, AIDS or AIDS-related complications; subjects using prescription medications or Natural Health Products; Subjects will be excluded if they have any condition which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Satiety Scores of a Carbohydrate Meal to a Meal of Equal Volume in Which Half of the Volume is Replaced With a Highly Viscous Gel.
To evaluate the effects of Konjac on satiety and subsequent food intake in healthy individuals.
- Conditions
- Obesity
- Being tested
- Konjac noodles, Carbohydrate and Konjac Noodles, Carbohydrate noodles
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Konjac noodlesDietary supplement
Also called Konnyaku - Konjac Noodles, Wellbond Import export, Scarborough, Ontario MIW 2P7
Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)
Carbohydrate and Konjac NoodlesDietary supplement
Also called Konnyaku - Konjac Noodles, Wellbond Import export, Scarborough, Ontario MIW 2P7, Capellini n°1
Carbohydrate noodlesDietary supplement
Also called Capellini n°1, Barilla America Inc., Bannockburn, Il 60015
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate Noodles | Placebo comparator | 0g Konjac Noodles Receives: Dietary Supplement: Konjac noodles; Dietary Supplement: Carbohydrate and Konjac Noodles; Dietary Supplement: Carbohydrate noodles |
| Carbohydrate and Konjac Noodles | Experimental | Half Carbohydrate and Half Non-Caloric Konjac Noodles - 122.5g Konjac Receives: Dietary Supplement: Konjac noodles; Dietary Supplement: Carbohydrate and Konjac Noodles; Dietary Supplement: Carbohydrate noodles |
| Konjac Noodles | Experimental | Non-Caloric Konjac Noodles (viscous gel meal) - 240g Konjac Receives: Dietary Supplement: Konjac noodles; Dietary Supplement: Carbohydrate and Konjac Noodles; Dietary Supplement: Carbohydrate noodles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Satiety
Objective satiety will be measured through subsequent food intake.
At each visit, participants will consume a pre-weighed snack (wafer cookies) that will be administered ad libitum at 90mins after consumption of the test meal. Subsequent food intake will be calculated by weighing the amount of the snack food left after consumption.
Measured: 90 minutes
Secondary outcomes (1)
Subjective Satiety
At each visit, participants will record their subjective satiety ratings using a 100 mm visual analogue scale and these rating will be combined into a total subjective appetite score using the formula (Q1+Q2+(100-Q3)+Q4)/4.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionJan 2012
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875627
- Sponsor's protocol ID
- 10-353
- Acronym
- InGel
- Status last verified
- May 2013
- First submitted
- 15 Feb 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Satiety Scores of a Carbohydrate Meal to a Meal of Equal Volume in Which Half of the Volume is Replaced With a Highly Viscous Gel.
- ClinicalTrials.gov ID
- NCT01875627
- Acronym / sponsor ID
- InGel / 10-353
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Jun 2013 (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.
To evaluate the effects of Konjac on satiety and subsequent food intake in healthy individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Noodles | Placebo comparator | Dietary Supplement: Konjac noodles, Dietary Supplement: Carbohydrate and Konjac Noodles, Dietary Supplement: Carbohydrate noodles0g Konjac Noodles |
| Carbohydrate and Konjac Noodles | Experimental | Dietary Supplement: Konjac noodles, Dietary Supplement: Carbohydrate and Konjac Noodles, Dietary Supplement: Carbohydrate noodlesHalf Carbohydrate and Half Non-Caloric Konjac Noodles - 122.5g Konjac |
| Konjac Noodles | Experimental | Dietary Supplement: Konjac noodles, Dietary Supplement: Carbohydrate and Konjac Noodles, Dietary Supplement: Carbohydrate noodlesNon-Caloric Konjac Noodles (viscous gel meal) - 240g Konjac |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women
- Age 18-65 years
- Having a BMI of 18.5 - 25 kg/m2
- No presence of major disease
Key exclusion criteria (1 listed)
- Known history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, gastrointestinal disease, AIDS or AIDS-related complications; subjects using prescription medications or Natural Health Products; Subjects will be excluded if they have any condition which, in the opinion of the investigator, 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 noodlesAlso: Konnyaku - Konjac Noodles, Wellbond Import export, Scarborough, Ontario MIW 2P7Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal) | Dietary supplement | Carbohydrate Noodles, Carbohydrate and Konjac Noodles, Konjac Noodles |
| Carbohydrate and Konjac NoodlesAlso: Konnyaku - Konjac Noodles, Wellbond Import export, Scarborough, Ontario MIW 2P7, Capellini n°1 | Dietary supplement | Carbohydrate Noodles, Carbohydrate and Konjac Noodles, Konjac Noodles |
| Carbohydrate noodlesAlso: Capellini n°1, Barilla America Inc., Bannockburn, Il 60015 | Dietary supplement | Carbohydrate Noodles, Carbohydrate and Konjac Noodles, Konjac Noodles |
Primary outcome
Objective Satiety
Time frame: 90 minutes
Objective satiety will be measured through subsequent food intake. At each visit, participants will consume a pre-weighed snack (wafer cookies) that will be administered ad libitum at 90mins after consumption of the test meal. Subsequent food intake will be calculated by weighing the amount of the snack food left after consumption.
1 secondary outcome
Subjective Satiety
Time frame: 90 minutes
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 12 Jun 2013.
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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
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 noodles, Carbohydrate and Konjac Noodles and Carbohydrate noodles 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 1 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 12 Jun 2013. 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. 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 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?
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?
Objective Satiety (time frame: 90 minutes). 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 12 Jun 2013.