Insulin Resistance SyndromePhase 2NCT03741686
Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome
A Phase 2 study testing konjac glucomannan and wheat bran in people with Insulin Resistance Syndrome, run by Unity Health Toronto.
Trial summary
To study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Insulin Resistance Syndrome
- What is being tested?
- konjac glucomannan and wheat bran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jan 1991to Jun 1999
- Phase
- Phase 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerant
- Clinical absent of CHD
- BMI less than 30 kg/m2
- Presence of full insulin resistance syndrome
- Reduced HDL cholesterol
- Elevated serum triglycerides
- Moderate hypertension
Who cannot join
- Regular smoking
- Regular alcohol consumption
- Family history of premature coronary heart disease
- Hypothyroidism
- Renal, hepatic or gastrointestinal disease
- Taking medications for hyperglycemia
- Taking medications for hyperlipidemia
- Taking medications for hypertension
About this study
Official title: Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome
To study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.
- Conditions
- Insulin Resistance Syndrome
- Being tested
- konjac glucomannan, wheat bran
- Keywords
- insulin resistance syndrome, fiber, konjac
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
konjac glucomannanDietary supplement
Konjac-mannan fiber-enriched biscuits (0.5 g/412KJ [100kcal] of glucommanan)
wheat branDietary supplement
Wheat bran (hard red wheat bran) fiber enriched biscuits
| Study group | Role | What they receive |
|---|---|---|
| Konjac-mannan | Experimental | Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet. Receives: Dietary Supplement: konjac glucomannan |
| Placebo | Placebo comparator | wheat bran fiber biscuits with NCEP Step II metabolically controlled diet. Receives: Dietary Supplement: wheat bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in total:HDL cholesterol
Measured: change from baseline after 3 weeks, relative to control
change in fructosamine
Measured: change from baseline after 3 weeks, relative to control
change in systolic blood pressure
Measured: change from baseline after 3 weeks, relative to control
Secondary outcomes (10)
change in total cholesterol
Measured: change from baseline after 3 weeks, relative to control
change in LDL cholesterol
Measured: change from baseline after 3 weeks, relative to control
change in HDL cholesterol
Measured: change from baseline after 3 weeks, relative to control
change in apolipoprotein A-1
Measured: change from baseline after 3 weeks, relative to control
change in apolipoprotain B
Measured: change from baseline after 3 weeks, relative to control
change in glucose
Measured: change from baseline after 3 weeks, relative to control
change in insulin
Measured: change from baseline after 3 weeks, relative to control
change in diastolic blood pressure
Measured: change from baseline after 3 weeks, relative to control
change in body weight
Measured: change from baseline after 3 weeks, relative to control
change in apoB:ApoA-1
Measured: change from baseline after 3 weeks, relative to control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study startJan 1991
- Primary completionJun 1992
- Study completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Resistance SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dicofarm, University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741686
- Sponsor's protocol ID
- Konjac in Insulin Resistance
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome
- ClinicalTrials.gov ID
- NCT03741686
- Acronym / sponsor ID
- Konjac in Insulin Resistance
- Conditions
- Insulin Resistance Syndrome
- Keywords
- insulin resistance syndrome, fiber, konjac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Dicofarm, University of Toronto
- Study start
- Jan 1991 (actual)
- Primary completion
- Jun 1992 (actual)
- Study completion
- Jun 1999 (actual)
- First posted
- 15 Nov 2018 (actual)
- 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 study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Konjac-mannan | Experimental | Dietary Supplement: konjac glucomannanKonjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet. |
| Placebo | Placebo comparator | Dietary Supplement: wheat branwheat bran fiber biscuits with NCEP Step II metabolically controlled diet. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Impaired glucose tolerant
- Clinical absent of CHD
- BMI less than 30 kg/m2
- Presence of full insulin resistance syndrome
- Reduced HDL cholesterol
Key exclusion criteria (8 listed)
- Regular smoking
- Regular alcohol consumption
- Family history of premature coronary heart disease
- Hypothyroidism
- Renal, hepatic or gastrointestinal disease
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-mannan fiber-enriched biscuits (0.5 g/412KJ [100kcal] of glucommanan) | Dietary supplement | Konjac-mannan |
| wheat branWheat bran (hard red wheat bran) fiber enriched biscuits | Dietary supplement | Placebo |
Primary outcome
change in total:HDL cholesterol
Time frame: change from baseline after 3 weeks, relative to control
change in fructosamine
Time frame: change from baseline after 3 weeks, relative to control
change in systolic blood pressure
Time frame: change from baseline after 3 weeks, relative to control
10 secondary outcomes
change in total cholesterol
Time frame: change from baseline after 3 weeks, relative to control
change in LDL cholesterol
Time frame: change from baseline after 3 weeks, relative to control
change in HDL cholesterol
Time frame: change from baseline after 3 weeks, relative to control
change in apolipoprotein A-1
Time frame: change from baseline after 3 weeks, relative to control
change in apolipoprotain B
Time frame: change from baseline after 3 weeks, relative to control
change in glucose
Time frame: change from baseline after 3 weeks, relative to control
change in insulin
Time frame: change from baseline after 3 weeks, relative to control
change in diastolic blood pressure
Time frame: change from baseline after 3 weeks, relative to control
change in body weight
Time frame: change from baseline after 3 weeks, relative to control
change in apoB:ApoA-1
Time frame: change from baseline after 3 weeks, relative to control
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 15 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing konjac glucomannan and wheat bran in people with Insulin Resistance Syndrome, run by Unity Health Toronto.
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 7 inclusion and 8 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 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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 total:HDL cholesterol (time frame: change from baseline after 3 weeks, relative to control). The study lists 3 primary outcomes in all. 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 15 Nov 2018.