Konjac-Glucomannan Fibre Blend and American Ginseng in Type 2 Diabetes
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
1 other identifier
interventional
39
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus-type-2
Started Mar 2002
Longer than P75 for phase_2 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 2, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedJune 20, 2016
June 1, 2016
2.7 years
March 2, 2016
June 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
Difference at week 12 between control and test intervention
Week 12
Secondary Outcomes (10)
Total Cholesterol
Week 12
High sensitivity C reactive protein
Week 12
Apolipoprotein A and B
Week 12
Oxidized LDL
Week 12
Blood pressure
Week 12
- +5 more secondary outcomes
Other Outcomes (6)
AST
Week 12
creatinine
Week 12
Clotting factors
Week 12
- +3 more other outcomes
Study Arms (2)
Control
PLACEBO COMPARATOR3g/d Cornstarch and 14g/d wheat bran control
K-GB&AG
EXPERIMENTAL3g/d American Ginseng and 7g/d Konjac-glucomannan fiber blend
Interventions
Blend of 2 viscous fibers: konjac mannan and xanthan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- treated with insulin
- age less than 40 or older than 75 years old at the start of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vladimir Vuksanlead
- Canadian Diabetes Associationcollaborator
Study Sites (1)
Clinical Risk Factor and Modification Centre
Toronto, Ontario, M5C 2T2, Canada
Related Publications (1)
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.
PMID: 28687934DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vladimir Vuksan, PhD
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
March 2, 2016
First Posted
June 20, 2016
Study Start
March 1, 2002
Primary Completion
November 1, 2004
Study Completion
March 1, 2005
Last Updated
June 20, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share