Study: NCT01377961

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks
Description: After the screening and OGTT, the treatment group each subject will be in is decided by randomization. Neither subject nor the researchers will be allowed to choose which group a subject is assigned to. A single patient/subject cannot be assigned more than 1 allocation number. Each subject will be assigned randomly (like drawing straws) to receive either on the pills containing the combination of 6mg lycopene and 50mg isoflavones or placebo. Each subject has a 1 in 2 chance of receiving one of these treatments.~The subject are advised to take one capsule of Laflavon/Placebo by mouth daily for 12 weeks.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks
Description: After the screening and OGTT, the treatment group each subject will be in is decided by randomization. Neither subject nor the researchers will be allowed to choose which group a subject is assigned to. A single patient/subject cannot be assigned more than 1 allocation number. Each subject will be assigned randomly (like drawing straws) to receive either on the pills containing the combination of 6mg lycopene and 50mg isoflavones or placebo. Each subject has a 1 in 2 chance of receiving one of these treatments.~The subject are advised to take one capsule of Laflavon/Placebo by mouth daily for 12 weeks.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Screening
Description: Volunteer will be screened as an out patient with a history, physical examination, baseline fasting plasma glucose or A1C, creatinine, AST/ALT, TSH. We may utilize the lab results of the subject available upto 3months prior to the consent date. Pregnancy tests will be performed for female candidates. Information of the level of physical activity, diet, supplements and medications will be obtained.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Screening
Description: Volunteer will be screened as an out patient with a history, physical examination, baseline fasting plasma glucose or A1C, creatinine, AST/ALT, TSH. We may utilize the lab results of the subject available upto 3months prior to the consent date. Pregnancy tests will be performed for female candidates. Information of the level of physical activity, diet, supplements and medications will be obtained.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: OGTT
Description: OGTT will be done after the screening at Baseline and at the completion of the 12 weeks of taking the supplements by the subject.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Anthropometrics and Blood pressure
Description: Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Anthropometrics and Blood pressure
Description: Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Screening
Description: Volunteer will be screened as an out patient with a history, physical examination, baseline fasting plasma glucose or A1C, creatinine, AST/ALT, TSH. We may utilize the lab results of the subject available upto 3months prior to the consent date. Pregnancy tests will be performed for female candidates. Information of the level of physical activity, diet, supplements and medications will be obtained.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blood Drawing
Description: The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blood Drawing
Description: The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.