Effect of Lycopene and Isoflavones on Glucose Metabolism
Primary Purpose
Metabolic Syndrome, Diabetes Mellitus, Non-Insulin-Dependent
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks
Screening
OGTT
Anthropometrics and Blood pressure
Screening
Blood Drawing
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility 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
Sites / Locations
- Internal Medicine
- Stark Diabetes Center Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm1: Metabolic Syndrome Volunteers
Arm 2:Previously Diagnosed diabetic patients
Arm Description
Outcomes
Primary Outcome Measures
Insulin Resistance
For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks.
A1C
For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks.
Secondary Outcome Measures
For Arm 1 :AUCglucose
For Arm 1: Changes of AUCglucose from baseline to 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.
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.
Full Information
NCT ID
NCT01377961
First Posted
March 30, 2011
Last Updated
June 24, 2015
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT01377961
Brief Title
Effect of Lycopene and Isoflavones on Glucose Metabolism
Official Title
Effect of Lycopene and Isoflavones on Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
FDA needs more information from the manufacturing company of the supplements.
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes Mellitus, Non-Insulin-Dependent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm1: Metabolic Syndrome Volunteers
Arm Type
Active Comparator
Arm Title
Arm 2:Previously Diagnosed diabetic patients
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
OGTT
Intervention Description
OGTT will be done after the screening at Baseline and at the completion of the 12 weeks of taking the supplements by the subject.
Intervention Type
Other
Intervention Name(s)
Anthropometrics and Blood pressure
Intervention Description
Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood Drawing
Intervention Description
The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.
Primary Outcome Measure Information:
Title
Insulin Resistance
Description
For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks.
Time Frame
12 weeks
Title
A1C
Description
For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
For Arm 1 :AUCglucose
Description
For Arm 1: Changes of AUCglucose from baseline to 12 weeks.
Time Frame
12 weeks
Title
For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations
Description
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.
Time Frame
12 weeks
Title
For Arm 1 :AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones concentration,EPCs count and function,Chlamydia Trachomatis titers in serum
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Abate, MD
Organizational Affiliation
UTMB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internal Medicine
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Stark Diabetes Center Clinic
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
12. IPD Sharing Statement
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Effect of Lycopene and Isoflavones on Glucose Metabolism
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