Effect of Combinatory Treatment with Lycopene/Soy Isoflavone on Glycemic Control and Plasma Lipid Profile in Individuals with Metabolic Syndrome

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000629033

Acronym

None

Enrollment

Registered

2010-08-02

Start date

2010-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

Exclusion criteria

Any clinical evidence of type 2 diabetes or any pharmocological treatment for diabetes (any oral anti-hyperglycemic agent).

Outcome results