HealthyPhase 1/2FI-FORMNCT01657058
Effects of Mode of Administration of Soluble Fibre Blend on Glycemia, Appetite & Sensory Parameters
A Phase 1/2 study testing Soluble viscous fibre blend powder in hydrophobic matrix, Soluble viscous fibre blend in pre hydrated form and No soluble viscous fibre blend in people with Healthy, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Soluble, viscous fibre has been established as an effective dietary component for lowering postprandial glycemia and promoting satiety. The effectiveness of viscous fibre has been related to its ability to increase the viscosity of the intra-luminal contents of the small intestine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Soluble viscous fibre blend powder in hydrophobic matrix, Soluble viscous fibre blend in pre hydrated form and No soluble viscous fibre blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Oct 2014
- Phase
- Phase 1/2
- 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
- age 18-65 years
- normal glycemic response
- BMI between 18.5 - 25 kg/m2
- peripheral systolic and diastolic blood pressure <140 mmHg and <90 mmHg, respectively.
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
- allergies to any of the test products
- Presence of an eating disorder
- Following a restrictive dieting regime
- Weight loss of >5kg in last 2 months
- Smoking cigarettes
Show all 9Show fewer
- Alcohol intake >2 drinks/day
- using prescription medications or Natural Health Products;
- 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: The Effects of Different Modes of Administration of Soluble Fibre on Postprandial and Second Meal Blood Glucose Response, Appetite and Sensory Parameters in Healthy Individuals
Soluble, viscous fibre has been established as an effective dietary component for lowering postprandial glycemia and promoting satiety. The effectiveness of viscous fibre has been related to its ability to increase the viscosity of the intra-luminal contents of the small intestine. Hence, the proposed mechanism with which soluble fibre affects the glycemic response, dependent on the viscosity development in the gut, would require that soluble fibre be extractable from the food matrix. This, in part, may be dependent on the food matrix that the soluble fibre is incorporated in. While properties of soluble fibre and their physiological effects have been studied extensively, limited data exists on the most effective mode of administration of fibre to optimize benefits. Furthermore, there are no studies to date that have evaluated how different modes of highly viscous soluble fibre would affect the subsequent meal. Hence, we propose a research study to determine whether the form of administration, taking into consideration the carbohydrate availability of a viscous fibre blend supplement, has a significant impact on postprandial and second meal glycemic response and subjective satiety in healthy individuals.
Read the detailed description
Following a 10-12 hr overnight fast, subjects will visit the Risk Factor Modification Centre between 8:00 am and 1:00 pm. Blood pressure and anthropometric measurements, including body weight, height, and % body fat will be taken. An initial finger prick fasting blood sample will be taken and a subjective appetite questionnaire in the form of a 100 mm visual analog scale will be completed. Subsequently, one of the 5 study meals will be administered to the subject to consume over a 10-15 minute duration accompanied by 300ml of water. Subjects will then be asked to complete a palatability questionnaire. Over the following 3 hours capillary blood samples will be taken by finger pricks at 15, 30, 45, 60, 90, 120 and 180 minutes post treatment. Appetite and symptoms questionnaires will be completed at 15, 30, 45, 60, 75, 90, and 120. At 180 min, a second standardized meal will be administered, consisting of 400kcal of pizza and 200ml of water. Further finger pick blood samples will be taken at 15, 30, 45, 60 and 120 min post pizza consumption. Upon completion of the visit, subjects will be given a 24-hour symptoms questionnaire to complete at home as an additional safety measure for a 24-hour period.
- Conditions
- Healthy
- Being tested
- Soluble viscous fibre blend powder in hydrophobic matrix, Soluble viscous fibre blend in pre hydrated form, No soluble viscous fibre blend, Soluble viscous fibre blend premixed with ½ carbohydrate gel, No soluble viscous fibre blend, ½ carbohydrate jello
- Keywords
- soluble fiber, second meal effect, glycemia, satiety, Individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble viscous fibre blend powder in hydrophobic matrixDietary supplement
5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello
Soluble viscous fibre blend in pre hydrated formDietary supplement
0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello
No soluble viscous fibre blendDietary supplement
0g soluble viscous fibre blend margarine + white bread + jello
Soluble viscous fibre blend premixed with ½ carbohydrate gelDietary supplement
Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
No soluble viscous fibre blend, ½ carbohydrate jelloDietary supplement
Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
| Study group | Role | What they receive |
|---|---|---|
| Treatment # 1 | Experimental | Soluble viscous fibre blend powder in hydrophobic matrix Receives: Dietary Supplement: Soluble viscous fibre blend powder in hydrophobic matrix |
| Treatment # 2 | Experimental | Soluble viscous fibre blend in pre hydrated form Receives: Dietary Supplement: Soluble viscous fibre blend in pre hydrated form |
| Control # 1 | Placebo comparator | No soluble viscous fibre blend Receives: Dietary Supplement: No soluble viscous fibre blend |
| Treatment # 3 | Experimental | Soluble viscous fibre blend premixed with ½ carbohydrate gel Receives: Dietary Supplement: Soluble viscous fibre blend premixed with ½ carbohydrate gel |
| Control # 2 | Placebo comparator | No soluble viscous fibre blend, ½ carbohydrate jello Receives: Dietary Supplement: No soluble viscous fibre blend, ½ carbohydrate jello |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemia
To investigate the effectiveness of soluble dietary fibre blend supplementation depending on 1) mode of administration and 2) carbohydrate incorporation on reducing postprandial glycemia when consumed with a standardized test breakfast.
Measured: 5 hours
Secondary outcomes (3)
Satiety
To investigate the effectiveness of soluble dietary fibre blend supplementation depending on 1) mode of administration and 2) carbohydrate incorporation on subjective satiety when consumed with a standardized test breakfast.
At each visit, participants will record their subjective ratings using a 100mm visual analogue scale and these ratings will be combined into a total subjective appetite score.
Measured: 5 hours
Second Meal Glycemia
To investigate the effectiveness of these different methods of administration of konjac fibre blend on postprandial glycemia of the second standardized meal.
Measured: 2 hours
Palatability
At each visit, participants will record their subjective ratings using a 100mm visual analogue scale and these ratings will be combined into a total subjective palatability score.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Vuksan, Unity Health Toronto
- Investigators
- Vladimir Vuksan, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657058
- Sponsor's protocol ID
- 12-147
- Acronym
- FI-FORM
- Status last verified
- Mar 2014
- First submitted
- 1 Aug 2012
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Modes of Administration of Soluble Fibre on Postprandial and Second Meal Blood Glucose Response, Appetite and Sensory Parameters in Healthy Individuals
- ClinicalTrials.gov ID
- NCT01657058
- Acronym / sponsor ID
- FI-FORM / 12-147
- Conditions
- Healthy
- Keywords
- soluble fiber, second meal effect, glycemia, satiety, Individuals
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2014 (estimated)
- First posted
- 3 Aug 2012 (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.
Soluble, viscous fibre has been established as an effective dietary component for lowering postprandial glycemia and promoting satiety. The effectiveness of viscous fibre has been related to its ability to increase the viscosity of the intra-luminal contents of the small intestine. Hence, the proposed mechanism with which soluble fibre affects the glycemic response, dependent on the viscosity development in the gut, would require that soluble fibre be extractable from the food matrix. This, in part, may be dependent on the food matrix that the soluble fibre is incorporated in. While properties of soluble fibre and their physiological effects have been studied extensively, limited data exists on the most effective mode of administration of fibre to optimize benefits. Furthermore, there are no studies to date that have evaluated how different modes of highly viscous soluble fibre would affect the subsequent meal. Hence, we propose a research study to determine whether the form of administration, taking into consideration the carbohydrate availability of a viscous fibre blend supplement, has a significant impact on postprandial and second meal glycemic response and subjective satiety in healthy individuals.
Detailed description
Following a 10-12 hr overnight fast, subjects will visit the Risk Factor Modification Centre between 8:00 am and 1:00 pm. Blood pressure and anthropometric measurements, including body weight, height, and % body fat will be taken. An initial finger prick fasting blood sample will be taken and a subjective appetite questionnaire in the form of a 100 mm visual analog scale will be completed. Subsequently, one of the 5 study meals will be administered to the subject to consume over a 10-15 minute duration accompanied by 300ml of water. Subjects will then be asked to complete a palatability questionnaire. Over the following 3 hours capillary blood samples will be taken by finger pricks at 15, 30, 45, 60, 90, 120 and 180 minutes post treatment. Appetite and symptoms questionnaires will be completed at 15, 30, 45, 60, 75, 90, and 120. At 180 min, a second standardized meal will be administered, consisting of 400kcal of pizza and 200ml of water. Further finger pick blood samples will be taken at 15, 30, 45, 60 and 120 min post pizza consumption. Upon completion of the visit, subjects will be given a 24-hour symptoms questionnaire to complete at home as an additional safety measure for a 24-hour period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment # 1 | Experimental | Dietary Supplement: Soluble viscous fibre blend powder in hydrophobic matrixSoluble viscous fibre blend powder in hydrophobic matrix |
| Treatment # 2 | Experimental | Dietary Supplement: Soluble viscous fibre blend in pre hydrated formSoluble viscous fibre blend in pre hydrated form |
| Control # 1 | Placebo comparator | Dietary Supplement: No soluble viscous fibre blendNo soluble viscous fibre blend |
| Treatment # 3 | Experimental | Dietary Supplement: Soluble viscous fibre blend premixed with ½ carbohydrate gelSoluble viscous fibre blend premixed with ½ carbohydrate gel |
| Control # 2 | Placebo comparator | Dietary Supplement: No soluble viscous fibre blend, ½ carbohydrate jelloNo soluble viscous fibre blend, ½ carbohydrate jello |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-65 years
- normal glycemic response
- BMI between 18.5 - 25 kg/m2
- peripheral systolic and diastolic blood pressure <140 mmHg and <90 mmHg, respectively.
Key exclusion criteria (9 listed)
- Known reported history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, Celiac disease/gastrointestinal disease, or AIDS
- allergies to any of the test products
- Presence of an eating disorder
- Following a restrictive dieting regime
- Weight loss of >5kg in last 2 months
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 |
|---|---|---|
| Soluble viscous fibre blend powder in hydrophobic matrix5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello | Dietary supplement | Treatment # 1 |
| Soluble viscous fibre blend in pre hydrated form0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello | Dietary supplement | Treatment # 2 |
| No soluble viscous fibre blend0g soluble viscous fibre blend margarine + white bread + jello | Dietary supplement | Control # 1 |
| Soluble viscous fibre blend premixed with ½ carbohydrate gelMargarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose | Dietary supplement | Treatment # 3 |
| No soluble viscous fibre blend, ½ carbohydrate jelloMargarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose | Dietary supplement | Control # 2 |
Primary outcome
Postprandial glycemia
Time frame: 5 hours
To investigate the effectiveness of soluble dietary fibre blend supplementation depending on 1) mode of administration and 2) carbohydrate incorporation on reducing postprandial glycemia when consumed with a standardized test breakfast.
3 secondary outcomes
Satiety
Time frame: 5 hours
Second Meal Glycemia
Time frame: 2 hours
Palatability
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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 principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Soluble viscous fibre blend powder in hydrophobic matrix, Soluble viscous fibre blend in pre hydrated form and No soluble viscous fibre blend in people with Healthy, 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 9 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 7 Mar 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. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Postprandial glycemia (time frame: 5 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 7 Mar 2014.