Diabetes Mellitus, Type 2Phase 2NCT02806349
Konjac-Glucomannan Fibre Blend and American Ginseng in Type 2 Diabetes
A Phase 2 study testing American Ginseng and Konjac-glucomannan fiber blend in people with Diabetes Mellitus, Type 2, run by Vladimir Vuksan at 1 site in Canada.
Trial summary
The purpose of this study was to determine whether the co-administration of a konjac-glucomannan fibre blend and American ginseng in a randomized, placebo-controlled, cross-over trial can improve diabetes management. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- American Ginseng and Konjac-glucomannan fiber blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2002to Mar 2005
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes of at least 1 year
- age between 40 and 75 years old
- treated with diet and anti hyperglycemic medications
- HbA1c between 6.5% and 8.4%
- Systolic blood pressure <140mmHg
- Diastolic blood pressure <90mmHg
- Clinically euthyroid
- Normal renal and liver function
Who cannot join
- treated with insulin
- age less than 40 or older than 75 years old at the start of the trial
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Risk Factor and Modification Centre
Toronto, Ontario, M5C 2T2
About this study
Official title: Effect of Co-administration of a Konjac-Glucomannan Fibre Blend and American Ginseng (Panax Quinquefolius L.) on Glycemia and Serum Lipids in Well-controlled Type 2 Diabetes: A Randomized Controlled, Clinical Trial
The purpose of this study was to determine whether the co-administration of a konjac-glucomannan fibre blend and American ginseng in a randomized, placebo-controlled, cross-over trial can improve diabetes management.
Read the detailed description
The study used a partially blinded, randomized, placebo controlled, crossover design. Due to the nature of the fibres it was not possible to blind the participant with respect to type of fibre. The study was divided into two phases with each phase having a four 4-week run-in period, and a 12-week treatment period, separated by a minimum 4-week wash-out period.
The treatments consisted of an ad libitum Canadian Diabetes Association recommended diet supplemented with capsules which contained either cornstarch (control) or AG (test) and a fiber supplement consisting of either wheat bran (control) or a viscous fiber blend of konjac mannan and xanthan (test). Participants were asked to attend the clinic at weeks -4, 0, 3, 6, and 12 during each phase.
Outcome measures There were three levels of outcome measures including efficacy, safety, and compliance. Statistical analysis The results are presented as mean ± SEM and considered statistically significant at p<0.05. Statistical analysis was performed using the SAS version 8.2 (SAS Institute, Cary, NC). Parametric analyses were conducted following a comparison of the sampling distribution to a normal distribution (Shapiro-Wilk and Kolmogorov-Smirnov tests). GLM was used to perform two-way ANOVA to detect differences of outcome variables in treatments and visits, controlling for treatment sequence and sex. If the effect of treatment was significant then percent differences were calculated between weeks 12 of test and control and analyzed using the GLM repeated measures one-way ANOVA controlling for sex. Parametric analyses were conducted following a comparison of the sampling distribution to a normal distribution (Shapiro-Wilk and Kolmogorov-Smirnov tests). The tests did not reject the null hypothesis at α=0.05. All comparisons were paired, thus each participant served as his/her own control. As this was a cross-over study, only participants who completed the study were included in the analysis.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- American Ginseng, Konjac-glucomannan fiber blend, Control
- Keywords
- American ginseng, Konjac glucomannan fiber
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American GinsengDietary supplement
Also called Panax quinquefolius L.
herb
Konjac-glucomannan fiber blendDietary supplement
Blend of 2 viscous fibers: konjac mannan and xanthan
ControlDietary supplement
Fiber matched control for intervention (corn starch and wheat bran)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 3g/d Cornstarch and 14g/d wheat bran control Receives: Dietary Supplement: Control |
| K-GB&AG | Experimental | 3g/d American Ginseng and 7g/d Konjac-glucomannan fiber blend Receives: Dietary Supplement: American Ginseng; Dietary Supplement: Konjac-glucomannan fiber blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Difference at week 12 between control and test intervention
Measured: Week 12
Secondary outcomes (10)
Total Cholesterol
Difference at week 12 between control and test intervention
Measured: Week 12
High sensitivity C reactive protein
Difference at week 12 between control and test intervention
Measured: Week 12
Apolipoprotein A and B
Difference at week 12 between control and test intervention
Measured: Week 12
Oxidized LDL
Difference at week 12 between control and test intervention
Measured: Week 12
Blood pressure
Difference at week 12 between control and test intervention
Measured: Week 12
LDL Cholesterol
Difference at week 12 between control and test intervention
Measured: week 12
Triglycerides
Difference at week 12 between control and test intervention
Measured: week 12
HDL-cholesterol
Difference at week 12 between control and test intervention
Measured: week 12
fasting glucose
Difference at week 12 between control and test intervention
Measured: week 12
fasting insulin
Difference at week 12 between control and test intervention
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startMar 2002
- Primary completionNov 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vladimir Vuksan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Responsible party
- Sponsor-investigator, Vladimir Vuksan, Unity Health Toronto
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806349
- Sponsor's protocol ID
- RB02-014C
- Status last verified
- Jun 2016
- First submitted
- 2 Mar 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jenkins AL, Morgan LM, Bishop J, Jovanovski E, Jenkins DJA, Vuksan V. Co-administration of a konjac-based fibre blend and American ginseng (Panax quinquefolius L.) on glycaemic control and serum lipids in type 2 diabetes: a randomized controlled, cross-over clinical trial. Eur J Nutr. 2018 Sep;57(6):2217-2225. doi: 10.1007/s00394-017-1496-x. Epub 2017 Jul 7.
PubMed 28687934
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Co-administration of a Konjac-Glucomannan Fibre Blend and American Ginseng (Panax Quinquefolius L.) on Glycemia and Serum Lipids in Well-controlled Type 2 Diabetes: A Randomized Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT02806349
- Acronym / sponsor ID
- RB02-014C
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- American ginseng, Konjac glucomannan fiber
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Vladimir VuksanUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- Mar 2002
- Primary completion
- Nov 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 20 Jun 2016 (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 was to determine whether the co-administration of a konjac-glucomannan fibre blend and American ginseng in a randomized, placebo-controlled, cross-over trial can improve diabetes management.
Detailed description
The study used a partially blinded, randomized, placebo controlled, crossover design. Due to the nature of the fibres it was not possible to blind the participant with respect to type of fibre. The study was divided into two phases with each phase having a four 4-week run-in period, and a 12-week treatment period, separated by a minimum 4-week wash-out period.
The treatments consisted of an ad libitum Canadian Diabetes Association recommended diet supplemented with capsules which contained either cornstarch (control) or AG (test) and a fiber supplement consisting of either wheat bran (control) or a viscous fiber blend of konjac mannan and xanthan (test). Participants were asked to attend the clinic at weeks -4, 0, 3, 6, and 12 during each phase.
Outcome measures There were three levels of outcome measures including efficacy, safety, and compliance. Statistical analysis The results are presented as mean ± SEM and considered statistically significant at p<0.05. Statistical analysis was performed using the SAS version 8.2 (SAS Institute, Cary, NC). Parametric analyses were conducted following a comparison of the sampling distribution to a normal distribution (Shapiro-Wilk and Kolmogorov-Smirnov tests). GLM was used to perform two-way ANOVA to detect differences of outcome variables in treatments and visits, controlling for treatment sequence and sex. If the effect of treatment was significant then percent differences were calculated between weeks 12 of test and control and analyzed using the GLM repeated measures one-way ANOVA controlling for sex. Parametric analyses were conducted following a comparison of the sampling distribution to a normal distribution (Shapiro-Wilk and Kolmogorov-Smirnov tests). The tests did not reject the null hypothesis at α=0.05. All comparisons were paired, thus each participant served as his/her own control. As this was a cross-over study, only participants who completed the study were included in the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control3g/d Cornstarch and 14g/d wheat bran control |
| K-GB&AG | Experimental | Dietary Supplement: American Ginseng, Dietary Supplement: Konjac-glucomannan fiber blend3g/d American Ginseng and 7g/d Konjac-glucomannan fiber blend |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of type 2 diabetes of at least 1 year
- age between 40 and 75 years old
- treated with diet and anti hyperglycemic medications
- HbA1c between 6.5% and 8.4%
- Systolic blood pressure <140mmHg
Key exclusion criteria (2 listed)
- treated with insulin
- age less than 40 or older than 75 years old at the start of the trial
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 |
|---|---|---|
| American GinsengAlso: Panax quinquefolius L.herb | Dietary supplement | K-GB&AG |
| Konjac-glucomannan fiber blendBlend of 2 viscous fibers: konjac mannan and xanthan | Dietary supplement | K-GB&AG |
| ControlFiber matched control for intervention (corn starch and wheat bran) | Dietary supplement | Control |
Primary outcome
HbA1c
Time frame: Week 12
Difference at week 12 between control and test intervention
10 secondary outcomes
Total Cholesterol
Time frame: Week 12
High sensitivity C reactive protein
Time frame: Week 12
Apolipoprotein A and B
Time frame: Week 12
Oxidized LDL
Time frame: Week 12
Blood pressure
Time frame: Week 12
LDL Cholesterol
Time frame: week 12
Triglycerides
Time frame: week 12
HDL-cholesterol
Time frame: week 12
fasting glucose
Time frame: week 12
fasting insulin
Time frame: week 12
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 20 Jun 2016.
- Derived from this study: PubMed 28687934Jenkins AL, Morgan LM, Bishop J, Jovanovski E, Jenkins DJA, Vuksan V. Co-administration of a konjac-based fibre blend and American ginseng (Panax quinquefolius L.) on glycaemic control and serum lipids in type 2 diabetes: a randomized controlled, cross-over clinical trial. Eur J Nutr. 2018 Sep;57(6):2217-2225. doi: 10.1007/s00394-017-1496-x. Epub 2017 Jul 7.
- Individual participant dataSharing planned: No
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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
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 2 study testing American Ginseng and Konjac-glucomannan fiber blend in people with Diabetes Mellitus, Type 2, run by Vladimir Vuksan 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 8 inclusion and 2 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 20 Jun 2016. 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 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?
HbA1c (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02806349, which also lists 1 linked publication.
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 20 Jun 2016.