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Trial registered on ANZCTR


Registration number
ACTRN12610000629033
Ethics application status
Approved
Date submitted
30/07/2010
Date registered
2/08/2010
Date last updated
15/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Combinatory Treatment with Lycopene/Soy Isoflavone on Glycemic Control and Plasma Lipid Profile in Individuals with Metabolic Syndrome
Scientific title
Trial in Subjects with Mediterranean and Middle Eastern Ethnicity who have metabolic syndrome to evaluate the efficacy of a Lycopene/Soy Isoflavone nutritional supplement(LaFlavon) 7/50 mg pill taken daily for 3 months compared to placebo on glucose and insulin concentrations in this patient population.
Secondary ID [1] 252325 0
None
Universal Trial Number (UTN)
U1111-1115-9761
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 257832 0
Condition category
Condition code
Metabolic and Endocrine 258000 258000 0 0
Diabetes
Metabolic and Endocrine 258024 258024 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
to study the effect of dietary supplementation with Lycopene (7mg) and Soy Isoflavones (50 mg), LaFlavon, taken by mouth once a day with food for ninety days on glucose and insulin plasma levels as well as plasma and tissue lipid concentrations in patients with metabolic syndrome.
Intervention code [1] 256890 0
Treatment: Other
Intervention code [2] 256891 0
Prevention
Comparator / control treatment
placebo (inactive ingredients), taken orally once a day for 90 days
Control group
Placebo

Outcomes
Primary outcome [1] 258872 0
a improvement in glucose and insulin levels in this patient population (metabolic syndrome) after 90 days of oral intake of LaFlavon (lycopene 7mg/soy isoflavones 50mg) measured by using a standard oral glucose tolerance test.
Timepoint [1] 258872 0
timeframe- baseline and 90 days after beginning treatment
Secondary outcome [1] 265002 0
increased plasma concentration of the phytochemicals lycopene and soy isoflavones after 90 days oral intake of LaFlavon (lycopene 7 mg/ soy isoflavones 50 mg) measured by assessing serum concentration of these phytochemicals.
Timepoint [1] 265002 0
timeframe - baseline and 90 days after beginning treatment
Secondary outcome [2] 265003 0
improvement in Endothelial Progenitor Cell (EPC) and Circulating Endothelial Cell (CEC) count after 90 days oral intake of LaFlavon measured using plasma cell suspension ( buffy coat preparation) and analyzed by flow cytometry.
Timepoint [2] 265003 0
timeframe- baseline and 90 days after beginning treatment
Secondary outcome [3] 265005 0
improvement in adipose tissue function in the regulation of lipid and glucose metabolism after 90 days oral intake of LaFlavon measured using both serum and subcutaneous fat bioptate sampling.
Timepoint [3] 265005 0
timeframe- baseline and 90 days after beginning treatment
Secondary outcome [4] 265006 0
an improvement in the relationship between low-grade systemic inflammation(C-Reactive Protein, hsCRP) and chlamydial titres after 90 days oral intake of LaFlavon measured by both serum and fat bioptate sampling.
Timepoint [4] 265006 0
timeframe- baseline and 90 days after beginning treatment

Eligibility
Key inclusion criteria
Meditteranean and Middle Eastern(Arab) men and women between the ages of 18 and 75 (inclusive) who meet the International Diabetic Foundation(IDF) criteria for Metabolic Syndrome

Subjects must have a waist circumference adjusted for ethnicity (men >37in (94cm), women >31.5 in(80cm))


AND must meet two of the four following study criteria:

- Elevated plasma triglyceride level at or > 150mg/dl
- Reduced plasma HDL level (HDL cholesterol at or < 40
mg/dl in males, <50 in females
- Raised fasting plasma glucose level >100mg/dl
- Raised blood pressure(bp) systolic bp>130 mm/Hg
diastolic bp > 85 mm/Hg
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any clinical evidence of type 2 diabetes or any pharmocological treatment for diabetes (any oral anti-hyperglycemic agent).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2790 0
Tunisia
State/province [1] 2790 0

Funding & Sponsors
Funding source category [1] 257361 0
Commercial sector/Industry
Name [1] 257361 0
CamMedica, Ltd.
Address [1] 257361 0
Babraham Research Campus
Babraham, Cambridge
CB22 3AT, UK
Country [1] 257361 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
CamMedica, Ltd.
Address
Babraham Research Campus
Babraham, Cambridge
CB22 3AT, UK
Country
United Kingdom
Secondary sponsor category [1] 256603 0
None
Name [1] 256603 0
Address [1] 256603 0
Country [1] 256603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259380 0
Hospital Sahloul De Sousse
Ethics committee address [1] 259380 0
Republique Tunisienne
Ministere de la Sante Publique
Hospital Sahloul De Sousse
Route Ceinture-Cite Sahloul
4054 Sousse
Ethics committee country [1] 259380 0
Tunisia
Date submitted for ethics approval [1] 259380 0
04/03/2010
Approval date [1] 259380 0
05/03/2010
Ethics approval number [1] 259380 0
Ethics committee name [2] 259381 0
Hospital Sahloul De Sousse
Ethics committee address [2] 259381 0
Hospital Sahloul De Sousse
Republique Tunisienne
Ministere de la Sante Publique
Route Ceinture
Cite Sahloul 4054 Sousse
Ethics committee country [2] 259381 0
Tunisia
Date submitted for ethics approval [2] 259381 0
Approval date [2] 259381 0
05/03/2010
Ethics approval number [2] 259381 0

Summary
Brief summary
This clinical trial is designed to explore the role of dietary supplementation with lycopene and soy isoflavones in the improvement of glucose metabolism in patients with metabolic syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31444 0
Address 31444 0
Country 31444 0
Phone 31444 0
Fax 31444 0
Email 31444 0
Contact person for public queries
Name 14691 0
Regina Silver, RN, BA
Address 14691 0
95 Rockland Street
Swampscott, Ma.
USA 01907
Country 14691 0
United States of America
Phone 14691 0
00 +1 781-462-8539
Fax 14691 0
Email 14691 0
rsilver@cambridgetheranostics.co.uk
Contact person for scientific queries
Name 5619 0
Yuriy Bashmakov, M.D.
Address 5619 0
Cambridge Theranostics, Ltd.
Babraham Research Campus
Babraham, Cambridge
CB22 3AT, UK
Country 5619 0
United Kingdom
Phone 5619 0
+44 797-159-8348
Fax 5619 0
Email 5619 0
Yuriy@cammedica.com

No data has been provided for results reporting
Summary results
Not applicable