Effect of Lycopene and Isoflavones on Glucose Metabolism

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 Overview

• Status: Withdrawn
• Conditions: Metabolic Syndrome; Diabetes Mellitus, Non-Insulin-Dependent
• Intervention / Treatment: 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: Blood Drawing

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • Internal medicine
    • Galveston, Texas, United States, 77550
      • Stark Diabetes Center Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Nicola Abate, MD, UTMB

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: June 21, 2011
• First Posted (Estimate): June 22, 2011

Study Record Updates

• Last Update Posted (Estimate): June 26, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus, Type 2; Metabolic Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Radiation-Protective Agents; Lycopene
• Other Study ID Numbers: 10-065