Clinical trial NCT02806349: Konjac-Glucomannan Fibre Blend and American Ginseng in Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: American ginseng
Konjac glucomannan fiber
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2016-06-20
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* treated with insulin
* age less than 40 or older than 75 years old at the start of the trial

Primary outcomes:
measure: HbA1c
timeFrame: Week 12
Secondary outcomes:
measure: Total Cholesterol
timeFrame: Week 12
measure: High sensitivity C reactive protein
timeFrame: Week 12
measure: Apolipoprotein A and B
timeFrame: Week 12
measure: Oxidized LDL
timeFrame: Week 12
measure: Blood pressure
timeFrame: Week 12
measure: LDL Cholesterol
timeFrame: week 12
measure: Triglycerides
timeFrame: week 12
measure: HDL-cholesterol
timeFrame: week 12
measure: fasting glucose
timeFrame: week 12
measure: fasting insulin
timeFrame: week 12
Other outcomes:
measure: AST
timeFrame: Week 12
measure: creatinine
timeFrame: Week 12
measure: Clotting factors
timeFrame: Week 12
measure: Subjective symptoms
timeFrame: week 12
measure: Dietary change
timeFrame: week 12
measure: ALT
timeFrame: week 12
Locations:
city: Toronto
country: Canada
facility: Clinical Risk Factor and Modification Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.