Effect of Lycopene and Isoflavones on Glucose Metabolism

The University of Texas System (UT)

Status: Withdrawn

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01377961

10-065

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Arm1: Metabolic Syndrome Volunteers

Active Comparator group

Treatment:

Drug: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks

Other: Blood Drawing

Other: Screening

Other: Anthropometrics and Blood pressure

Other: Screening

Other: OGTT

Arm 2:Previously Diagnosed diabetic patients

Active Comparator group

Treatment:

Drug: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks

Other: Blood Drawing

Other: Screening

Other: Anthropometrics and Blood pressure

Other: Screening