Effect of Lycopene and Isoflavones on Glucose Metabolism - Full Text View

Purpose

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.

Condition	Intervention
Metabolic Syndrome Diabetes Mellitus, Non-Insulin-Dependent	Dietary Supplement: Randomized pills either containing combination of lycopene and isoflavones or Placebo to be taken for 12 weeks Other: Screening Other: OGTT Other: Measurements of height, weight, hip, waist and Blood Pressure Other: Blood Drawing through Venipuncture

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Lycopene and Isoflavones on Glucose Metabolism

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Metabolic Syndrome

Drug Information available for: Lycopene Dextrose

U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:

Insulin Resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks.
A1C [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks.

Secondary Outcome Measures:

For Arm 1 :AUCglucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
For Arm 1: Changes of AUCglucose from baseline to 12 weeks.
For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
For Arm 1 :AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones concentration,EPCs count and function,Chlamydia Trachomatis titers in serum [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	450
Study Start Date:	September 2010
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm1: Metabolic Syndrome Volunteers	Dietary Supplement: Randomized pills either containing combination of lycopene and isoflavones 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: Measurements of height, weight, hip, waist 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 through Venipuncture 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	Dietary Supplement: Randomized pills either containing combination of lycopene and isoflavones 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: Measurements of height, weight, hip, waist and Blood Pressure Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements. 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: Blood Drawing through Venipuncture The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.

Arms

Assigned Interventions

Active Comparator: Arm1: Metabolic Syndrome Volunteers

Dietary Supplement: Randomized pills either containing combination of lycopene and isoflavones 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: Measurements of height, weight, hip, waist 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 through Venipuncture

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

Dietary Supplement: Randomized pills either containing combination of lycopene and isoflavones 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: Measurements of height, weight, hip, waist and Blood Pressure

Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.

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: Blood Drawing through Venipuncture

The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377961

Locations

United States, Texas
Stark Diabetes Center Clinic
Galveston, Texas, United States, 77550
Internal Medicine
Galveston, Texas, United States, 77550

Sponsors and Collaborators

The University of Texas, Galveston

Investigators

Principal Investigator:

Nicola Abate, MD

UTMB

More Information

No publications provided

Responsible Party:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT01377961 History of Changes
Other Study ID Numbers:	10-065
Study First Received:	March 30, 2011
Last Updated:	December 6, 2011
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Lycopene

Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013