Metabolic SyndromeNCT01377961
Effect of Lycopene and Isoflavones on Glucose Metabolism
A study testing Screening, OGTT and Anthropometrics and Blood pressure in people with Metabolic Syndrome and Diabetes Mellitus, Non-Insulin-Dependent, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- Screening, OGTT and Anthropometrics and Blood pressure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Metabolic Syndrome (IDF criteria)
- Stable dose of medications for > 90 days
- 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
Who cannot join
- Pharmacological therapy for diabetes
- Flood allergies, especially to Whey protein, soy or tomato.
- Pregnancy
- Study group 2( Arm 2:: Diabetes mellitus patients group).
- HbA1c above 9.5% or below 7.5% in last 3 months
- TZD therapy for diabetes
Show all 9Show fewer
- Insulin therapy for diabetes
- Flood allergies, especially to Whey protein, soy or tomato
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Internal Medicine
Galveston, Texas, 77550
Stark Diabetes Center Clinic
Galveston, Texas, 77550
About this study
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.
- Being tested
- 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, Blood Drawing
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeksDrug
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.
ScreeningOther
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.
OGTTOther
OGTT will be done after the screening at Baseline and at the completion of the 12 weeks of taking the supplements by the subject.
Anthropometrics and Blood pressureOther
Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.
ScreeningOther
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.
Blood DrawingOther
The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: Metabolic Syndrome Volunteers | Active comparator | Not described Receives: 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 | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance
For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks.
Measured: 12 weeks
A1C
For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks.
Measured: 12 weeks
Secondary outcomes (3)
For Arm 1 :AUCglucose
For Arm 1: Changes of AUCglucose from baseline to 12 weeks.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: FDA needs more information from the manufacturing company of the supplements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Abate, MD, Principal investigator, UTMB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377961
- Sponsor's protocol ID
- 10-065
- Status last verified
- Jun 2015
- First submitted
- 30 Mar 2011
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lycopene and Isoflavones on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT01377961
- Acronym / sponsor ID
- 10-065
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA needs more information from the manufacturing company of the supplements.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years
- Metabolic Syndrome (IDF criteria)
- Stable dose of medications for > 90 days
- 18-75 years of age
- Type 2 diabetes (diagnosed with ADA criteria: fasting plasma glucose > 125 mg/dL)
Key exclusion criteria (9 listed)
- Pharmacological therapy for diabetes
- Flood allergies, especially to Whey protein, soy or tomato.
- Pregnancy
- Study group 2( Arm 2:: Diabetes mellitus patients group).
- HbA1c above 9.5% or below 7.5% in last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeksAfter 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. | Drug | Arm 2:Previously Diagnosed diabetic patients, Arm1: Metabolic Syndrome Volunteers |
| ScreeningVolunteer 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 | Arm 2:Previously Diagnosed diabetic patients, Arm1: Metabolic Syndrome Volunteers |
| OGTTOGTT will be done after the screening at Baseline and at the completion of the 12 weeks of taking the supplements by the subject. | Other | Arm1: Metabolic Syndrome Volunteers |
| Anthropometrics and Blood pressureMeasurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements. | Other | Arm 2:Previously Diagnosed diabetic patients, Arm1: Metabolic Syndrome Volunteers |
| ScreeningVolunteer 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 | Arm 2:Previously Diagnosed diabetic patients |
| Blood DrawingThe blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo. | Other | Arm 2:Previously Diagnosed diabetic patients, Arm1: Metabolic Syndrome Volunteers |
Primary outcome
Insulin Resistance
Time frame: 12 weeks
For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks.
A1C
Time frame: 12 weeks
For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks.
3 secondary outcomes
For Arm 1 :AUCglucose
Time frame: 12 weeks
For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Abate, MD principal investigator
UTMB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening, OGTT and Anthropometrics and Blood pressure in people with Metabolic Syndrome and Diabetes Mellitus, Non-Insulin-Dependent, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.