Effect of Lycopene and Isoflavones on Glucose Metabolism

Study Overview
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Brief Summary
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Type 2 diabetes mellitus (DM2) is a growing social health problem world-wide, in particular with respect to its contribution to cardiovascular disease. The progressive increase in prevalence of DM2 has reached epidemic proportion and is a major cause of morbidity and mortality in all populations around the world. Conventional stepwise treatment of DM2 generally focuses on controlling blood glucose concentration. However, the risk for side-effects associated with the use of pharmacological intervention often delays initiation of therapy, with the potential implication on worsening morbidity and mortality from complications. On the other hand, non-pharmacological intervention in the form of dietary restrictions, exercise and weight loss, is safe but often difficult to accomplish. The availability of nutrients that affect glucose and lipid metabolism would provide an important practical tool to establish early intervention in newly diagnosed DM2 and perhaps even in patients who are only at risk for DM2. The investigators have recently obtained preliminary data on beneficial effects of combined supplementation of lycopene and isoflavones on glucose metabolism of normoglycemic volunteers with insulin resistance. This clinical trial will explore the role of isoflavones and lycopene dietary supplementation in the improvement of glucose metabolism of patients at increased risk or with established but mild DM2. The overall hypothesis is that supplementation of laflavon, provided as a new formulation that increases bioavailability of the individual components (Laflavon CamMedica contains 7 mg of Lycopene and 50 mg of Soy Isoflavones), determines improvement in glucose tolerance and insulin resistance of patients with the metabolic syndrome and also reduces HbA1c in patients with mild DM2.

Official Title
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Effect of Lycopene and Isoflavones on Glucose Metabolism

Conditions
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Metabolic Syndrome, Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Drug: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks
* Other: Screening
* Other: OGTT
* Other: Anthropometrics and Blood pressure
* Other: Screening
* Other: Blood Drawing


Participation Criteria
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Eligibility Criteria
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Study group 1( arm 1 ::metabolic syndrome group). Inclusion criteria: Age 18-75 years Metabolic Syndrome (IDF criteria) Stable dose of medications for > 90 days Exclusion criteria: Pharmacological therapy for diabetes Flood allergies, especially to Whey protein, soy or tomato. Pregnancy Study group 2( Arm 2:: Diabetes mellitus patients group). Inclusion criteria: 18-75 years of age Type 2 diabetes (diagnosed with ADA criteria: fasting plasma glucose > 125 mg/dL) Stable dose of medications for > 90 days Patients on diet/exercise, metformin, DD4 inhibitors (sitagliptin and saxagliptin) and /or sulphonylurea for > 90 days Exclusion criteria: HbA1c above 9.5% or below 7.5% in last 3 months TZD therapy for diabetes Insulin therapy for diabetes Flood allergies, especially to Whey protein, soy or tomato Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm1: Metabolic Syndrome Volunteers<br> | Drug: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks<br>* 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.<br>Other: Screening<br>* 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.<br>Other: OGTT<br>* OGTT will be done after the screening at Baseline and at the completion of the 12 weeks of taking the supplements by the subject.<br>Other: Anthropometrics and Blood pressure<br>* Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.<br>Other: Blood Drawing<br>* The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.<br>|
| Active Comparator: Arm 2:Previously Diagnosed diabetic patients<br> | Drug: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks<br>* 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.<br>Other: Screening<br>* 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.<br>Other: Anthropometrics and Blood pressure<br>* Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.<br>Other: Screening<br>* 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.<br>Other: Blood Drawing<br>* The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance | For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks. | 12 weeks | 
| A1C | For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For Arm 1 :AUCglucose | For Arm 1: Changes of AUCglucose from baseline to 12 weeks. | 12 weeks | 
| For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations | For Arm 2: Changes in the Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones, EPCs count and function, Chlamydia Trachomatis titers in serum from baseline to 12 weeks. | 12 weeks | 
| For Arm 1 :AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones concentration,EPCs count and function,Chlamydia Trachomatis titers in serum | For Arm 1: Changes of AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones,EPCs count and function,Chlamydia Trachomatis titers in serum from baseline to 12 weeks. | 12 weeks |