Effect of Lycopene and Isoflavones on Glucose Metabolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Insulin Resistance
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm1: Metabolic Syndrome Volunteers
Intervention: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks (Drug)
Arm1: Metabolic Syndrome Volunteers
Intervention: Screening (Other)
Arm1: Metabolic Syndrome Volunteers
Intervention: OGTT (Other)
Arm1: Metabolic Syndrome Volunteers
Intervention: Anthropometrics and Blood pressure (Other)
Arm1: Metabolic Syndrome Volunteers
Intervention: Blood Drawing (Other)
Arm 2:Previously Diagnosed diabetic patients
Intervention: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks (Drug)
Arm 2:Previously Diagnosed diabetic patients
Intervention: Screening (Other)
Arm 2:Previously Diagnosed diabetic patients
Intervention: Anthropometrics and Blood pressure (Other)
Arm 2:Previously Diagnosed diabetic patients
Intervention: Blood Drawing (Other)
Outcomes
Primary Outcomes
Insulin Resistance
Time Frame: 12 weeks
For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks.
A1C
Time Frame: 12 weeks
For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks.
Secondary Outcomes
- For Arm 1 :AUCglucose(12 weeks)
- For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations(12 weeks)
- For Arm 1 :AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones concentration,EPCs count and function,Chlamydia Trachomatis titers in serum(12 weeks)
