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Trial registered on ANZCTR


Registration number
ACTRN12618000031268
Ethics application status
Approved
Date submitted
30/11/2017
Date registered
12/01/2018
Date last updated
23/06/2022
Date data sharing statement initially provided
23/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Placebo controlled, double-blind study for efficacy of two herbal supplements (Trigonella foenum-graecum Seed Extract and Coccinia Grandis Extract) for Normalizing Elevated (pre-diabetic) blood Glucose and improving Insulin Sensitivity - a 3 arm study.
Scientific title
Placebo controlled, double-blind study for efficacy of two herbal supplements (Trigonella foenum-graecum Seed Extract and Coccinia Grandis Extract) for Normalizing Elevated (pre-diabetic) blood Glucose and improving Insulin Sensitivity - a 3 arm study.
Secondary ID [1] 293480 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
pre-diabetes 305669 0
diabetes 305670 0
Condition category
Condition code
Metabolic and Endocrine 304891 304891 0 0
Diabetes
Alternative and Complementary Medicine 305024 305024 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Trigonella foenum-graecum Seed Extract, 250mg twice per day (500mg/day) for 12 weeks. capsule taken orally.

Arm 2: Coccinia Grandis Extract, 500mg twice per day (1000mg.day) for 12 weeks, capsule taken orally.

Arm 3: Placebo (maltodextrin), 2 capsules per day, for 12 weeks,
Intervention code [1] 299723 0
Treatment: Other
Comparator / control treatment
Placebo controlled
Control group
Placebo

Outcomes
Primary outcome [1] 304082 0
Fasting and 2 hr blood glucose in oral glucose tolerance test, OGTT.
Timepoint [1] 304082 0
Baseline, Week 6 and week 12 (which is the primary outcome)
Primary outcome [2] 304087 0
Fasting and 2hr insulin in oral glucose tolerance test, OGTT.
Timepoint [2] 304087 0
Baseline, Week 6, Week 12 (which is primary outcome)
Secondary outcome [1] 340912 0
Glycosylated haemoglobin (HbA1c)
Timepoint [1] 340912 0
Baseline, week 6 and week 12
Secondary outcome [2] 340913 0
Lipid Studies on blood test
Timepoint [2] 340913 0
Baseline and week 12
Secondary outcome [3] 340914 0
Electrolyte / Liver Function blood test (composite blood test)
Timepoint [3] 340914 0
Baseline, Week 12
Secondary outcome [4] 341159 0
Body weight
Timepoint [4] 341159 0
Baseline, week 12
Secondary outcome [5] 341160 0
Safety outcomes :
Full Blood Count (RBC)
Timepoint [5] 341160 0
Baseline, Week 12
Secondary outcome [6] 341633 0
Reported adverse reactions - e.g irritation to nasal passages on application, or any gastrointestinal reactions.
Timepoint [6] 341633 0
Adverse reactions are monitored throughout the study be regular followup calls and scheduled clinic visits as well as assessment of the pathology results.

Eligibility
Key inclusion criteria
Male and females at least 18 years of age at time of entry on study;
Impaired Fasting blood glucose levels and/or insulin resistance;
BMI is greater than 25;
Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment;
Agree to undergo venipuncture on multiple occasions;
Agree to adhere to the study protocol, including not changing diet or major exercise patterns over the 12 week study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any clinically relevant abnormal findings which, in the opinion of the investigators/clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including:
- Physical examination; Clinical chemistry; Haematology; Urinalysis; Vital signs;
- Diagnosis of Type II Diabetes Mellitus
- Taking Anti-Obesity medications such as Orlistat
- Taking oral blood glucose-lowering medications such as Sulfonylureas, Biguanides, Alpha-glucosidase inhibitors, Thiazolidinediones
- Taking any dietary supplements or herbal medicines specifically for supporting blood sugar including lipoic acid and gymnemia etc.
- Have recent episodes of symptomatic coronary arterial disease, stroke, and any cardiovascular events including infarction (heart attack)
- Having treatment for cancers within last 5 years;
- Taking anti-coagulants such as warfarin;
- Having any allergies or past reactions to ingredients in treatment and placebo supplements, including fenugreek seeds, cucumber or maltodextrin;
- Alcohol abuse;
- The use of any illicit drugs;
- (Women only) Pregnancy or nursing of an infant; or not taking adequate precautions to prevent pregnancy; or not having had a normal menstrual cycle.
- Commencing lifestyle interventions such as major dietary changes and increasing exercise duration/intensity;
.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Efficacy: Sample size of 26 participants per group based on detecting a 0.37mmol/L change in fasting glucose within persons during treatment between active treatments and placebo group over the 12 weeks, assuming a 0.4 mmol/L SD in change score, at 80% power and a type I error of 5%. An additional 4 participants per group will be enrolled, in the event of withdrawals. (Total number of participants 78 + 12 = 90 to be enrolled.)
Data analysis: Efficacy analyses will be carried out on intent-to-treat population, consisting of all participants who are randomised, exposed to at least one dose of the study product, and then attended at least one follow-up (week 2 telephone check-in) after treatment initiation. This will include data from withdrawn participants. Safety analyses were based on data of all patients who received at least one dose of study product. All of the data will be expressed as mean ± standard deviation unless otherwise specified. Characteristic comparability between groups at baseline will be assessed by independent t-test for continuous data, or by Pearson chi-square test for categorical data. Changes from baseline of measured metabolic parameters, vital signs, as well as body weight at each visit will be analyzed individually between groups by independent t-test. In addition, each individual variable will be analyzed within group by repeated-measures analysis of variance, followed by contrast analysis. Laboratory safety variables at baseline and end of study will be statistically analyzed within group by paired t-test, and between groups by independent t-test. Throughout the analysis, the underlying distributional assumptions of the statistical models should have been met; otherwise, the corresponding nonparametric tests will be used. Interim Statistical Analysis: There will be no interim statistical analysis for efficacy or safety. The investigator will review adverse events as they arise.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2018
Actual
3/05/2018
Date of last participant enrolment
Anticipated
22/10/2018
Actual
24/12/2019
Date of last data collection
Anticipated
24/12/2018
Actual
4/04/2021
Sample size
Target
90
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18263 0
4005 - New Farm

Funding & Sponsors
Funding source category [1] 298099 0
Commercial sector/Industry
Name [1] 298099 0
Gencor Pacific Pty Ltd
Country [1] 298099 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
Evidence Sciences Pty. Ltd.
Address
P.O. Box 1193 New Farm Brisbane 4005 QLD
Country
Australia
Secondary sponsor category [1] 297188 0
None
Name [1] 297188 0
Address [1] 297188 0
Country [1] 297188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299119 0
Bellberry Ltd
Ethics committee address [1] 299119 0
Ethics committee country [1] 299119 0
Australia
Date submitted for ethics approval [1] 299119 0
07/08/2017
Approval date [1] 299119 0
06/11/2017
Ethics approval number [1] 299119 0
2017-08-601

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79358 0
Dr Elizabeth Steels
Address 79358 0
Evidence Sciences Pty. Ltd.
P.O.Box 1193 New Farm Brisbane 4005 QLD
Country 79358 0
Australia
Phone 79358 0
+61431003929
Fax 79358 0
Email 79358 0
drbeth@evidencesciences.com.au
Contact person for public queries
Name 79359 0
Elizabeth Steels
Address 79359 0
Evidence Sciences Pty. Ltd.
P.O.Box 1193 New Farm Brisbane 4005 QLD
Country 79359 0
Australia
Phone 79359 0
+61431003929
Fax 79359 0
Email 79359 0
drbeth@evidencesciences.com.au
Contact person for scientific queries
Name 79360 0
Elizabeth Steels
Address 79360 0
Evidence Sciences Pty. Ltd.
P.O.Box 1193 New Farm Brisbane 4005 QLD
Country 79360 0
Australia
Phone 79360 0
+61431003929
Fax 79360 0
Email 79360 0
drbeth@evidencesciences.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn Exploratory Study of the Safety and Efficacy of a Trigonella foenum-graecum Seed Extract in Early Glucose Dysregulation: A Double-Blind Randomized Placebo-Controlled Trial.2022https://dx.doi.org/10.3390/pharmaceutics14112453
EmbaseEffect of Coccinia grandis (Linn.) Voigt extract on glucose metabolism markers in a prediabetic population: A double-blind randomised clinical trial.2023https://dx.doi.org/10.1016/j.phyplu.2023.100487
N.B. These documents automatically identified may not have been verified by the study sponsor.