Effect of Lycopene and Isoflavones on Glucose Metabolism

Not Applicable

Withdrawn

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

• Registration Number: NCT01377961
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-22
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-26
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1: Metabolic Syndrome Volunteers	Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks	-
Arm1: Metabolic Syndrome Volunteers	Screening	-
Arm1: Metabolic Syndrome Volunteers	OGTT	-
Arm1: Metabolic Syndrome Volunteers	Anthropometrics and Blood pressure	-
Arm1: Metabolic Syndrome Volunteers	Blood Drawing	-
Arm 2:Previously Diagnosed diabetic patients	Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks	-
Arm 2:Previously Diagnosed diabetic patients	Screening	-
Arm 2:Previously Diagnosed diabetic patients	Anthropometrics and Blood pressure	-
Arm 2:Previously Diagnosed diabetic patients	Blood Drawing	-

Primary Outcome Measures

Name	Time	Method
Insulin Resistance	12 weeks	For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks.
A1C	12 weeks	For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks.

Secondary Outcome Measures

Name	Time	Method
For Arm 1 :AUCglucose	12 weeks	For Arm 1: Changes of AUCglucose from baseline to 12 weeks.
For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations	12 weeks	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	12 weeks	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.

Trial Locations

Locations (2)

Internal Medicine; 🇺🇸 Galveston, Texas, United States

Stark Diabetes Center Clinic; 🇺🇸 Galveston, Texas, United States