Effect of Lycopene and Isoflavones on Glucose Metabolism

NCT01377961 | Withdrawn DMC

• 1 other identifier: 10-065
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Syndrome; Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Arm1: Metabolic Syndrome Volunteers

ACTIVE COMPARATOR

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

Arm 2:Previously Diagnosed diabetic patients

ACTIVE COMPARATOR

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

Interventions

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

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.

Arm 2:Previously Diagnosed diabetic patients; Arm1: Metabolic Syndrome Volunteers

Screening OTHER

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.

Arm 2:Previously Diagnosed diabetic patients; Arm1: Metabolic Syndrome Volunteers

OGTT OTHER

OGTT will be done after the screening at Baseline and at the completion of the 12 weeks of taking the supplements by the subject.

Arm1: Metabolic Syndrome Volunteers

Anthropometrics and Blood pressure OTHER

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

Arm 2:Previously Diagnosed diabetic patients; Arm1: Metabolic Syndrome Volunteers

Blood Drawing OTHER

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

Arm 2:Previously Diagnosed diabetic patients; Arm1: Metabolic Syndrome Volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Metabolic Syndrome (IDF criteria)
• Stable dose of medications for \> 90 days

You may not qualify if:

• Pharmacological therapy for diabetes
• Flood allergies, especially to Whey protein, soy or tomato.
• Pregnancy
• Study group 2( Arm 2:: Diabetes mellitus patients group).
• 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
• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (2)

Internal Medicine

Galveston, Texas, 77550, United States

Location

Stark Diabetes Center Clinic

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus, Type 2

Interventions

Isoflavones; Dietary Supplements; Mass Screening; Glucose Tolerance Test; Blood Pressure; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques, Endocrine; Vital Signs; Physical Examination; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Nicola Abate, MD

  UTMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: June 22, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (2)