Back to resultsThe Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Insulin Resistance
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TA-65
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, insulin resistance, HDL cholesterol,
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria are:
men and women (40-70 y) with metabolic syndrome which means having at least 3 of the following characteristics:
- Blood pressure > 130/85 mm Hg
- plasma glucose > 100 mg/dL
- plasma triglycerides > 150 mg/dL
- HDL cholesterol < 40 mg/dL (men) and < 50 mg/dL (women)
- waist circumference >102 cm (men) and ≥ 88 cm (women)
- Women of childbearing age should be using contraception
Exclusion Criteria:
Exclusion criteria will be
- self-reported diabetes mellitus
- coronary heart disease
- triglycerides greater than 400 mg/dL
- Fasting glucose greater than 126 mg/dL
- Blood pressure greater than 140/100 mmg Hg
- history of stroke
- Use of alcohol at an elevated rate (more than two drinks per day)
- Renal problems
- liver disease
- cancer
- pregnancy and lactation
- severe infectious diseases
- autoimmune disease currently under treatment
- current hormone therapy
- previous treatment with TA-65.
- Intake of glucose-lowering prescriptions
- Use of immunosuppressants, lithium or supplements such as Sulphonylureas (Glucotrol, Amaryl), Thiazolidinedione (Avandia, ACTOS,), Meglitinides (Prandin, Starlix), Biguanides (Metformin), Alpha-glucosidase inhibitors (Precose, Glyset), dipeptidyl peptidase (DPP)-4 inhibitors (Januvia, Onglyza)
- high dose chromium or cinnamon supplements
- Consistent intake of vitamin, mineral, or multivitamin supplements prior to recruitment may be admitted into the study if they plan on maintaining their current supplement program.
However, subjects may not participate if they begin taking a new supplement during the 27-wk study period.
-Subjects will also be asked to refrain from taking any additional supplements, including fish oil, herb and concentrated antioxidant sources.
Sites / Locations
- University of Connecticut
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TA-65
Placebo
Arm Description
TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each
Placebo will be provided to volunteers for 12 weeks, 2 pills per day of 8 mg each.
Outcomes
Primary Outcome Measures
Plasma insulin levels
The supplement is anticipated to decrease insulin resistance in individuals with metabolic syndrome. The investigators will measure plasma insulin and plasma glucose as outcomes measures
Secondary Outcome Measures
plasma HDL cholesterol
It is expected that the TA-65 supplement will increase plasma HDL, another characteristic of metabolic syndrome
Full Information
NCT ID
NCT01753674
First Posted
December 17, 2012
Last Updated
May 27, 2015
Sponsor
University of Connecticut
1. Study Identification
Unique Protocol Identification Number
NCT01753674
Brief Title
The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
Official Title
The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
non-compliance issues
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Connecticut
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our hypothesis is that TA-65, a dietary supplement will help to reduce insulin resistance and plasma glucose in individuals classified with metabolic syndrome.
Detailed Description
This is double blind cross over randomized clinical trial. The supplement and placebo will be provided by TA Science, Inc. and prepared as described below. Subjects will be randomly allocated to consume either a daily serving of TA-65 (two capsules per day of 8 mg each) (please see attached label) or a placebo for 12 weeks. Randomization will be done in a sequential manner; the first subject will be allocated to supplement A and the next one to supplement B and so on. After a 3-week washout, they will be allocated to the alternate treatment for additional 12 weeks. Supplements (TA-65 or placebo) will be taken twice daily with a meal.
Participants will be advised not to change their diet or exercise protocols during the 27 week intervention. Volunteers will be required to provide a 5-day dietary record before starting the study, at the end of each supplement period (TA-65 or placebo) and at the end of the washout period. Subjects will have to fill an exercise questionnaire during the same times to ensure that there are no changes in physical activity. Participants will be asked to report to the department every 4 weeks for checking compliance on supplement intake and to assess weight and blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Insulin Resistance
Keywords
metabolic syndrome, insulin resistance, HDL cholesterol,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TA-65
Arm Type
Experimental
Arm Description
TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be provided to volunteers for 12 weeks, 2 pills per day of 8 mg each.
Intervention Type
Dietary Supplement
Intervention Name(s)
TA-65
Intervention Description
TA-65 will be provided to volunteers, 2 pills per day of 8 mg each
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo supplement will be provided to volunteers, 2 pills per day of 8 mg each
Primary Outcome Measure Information:
Title
Plasma insulin levels
Description
The supplement is anticipated to decrease insulin resistance in individuals with metabolic syndrome. The investigators will measure plasma insulin and plasma glucose as outcomes measures
Time Frame
27 weeks
Secondary Outcome Measure Information:
Title
plasma HDL cholesterol
Description
It is expected that the TA-65 supplement will increase plasma HDL, another characteristic of metabolic syndrome
Time Frame
27 weeks
Other Pre-specified Outcome Measures:
Title
blood pressure
Description
It is expected that the supplement will decrease blood pressure, another outcome of metabolic syndrome
Time Frame
27 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria are:
men and women (40-70 y) with metabolic syndrome which means having at least 3 of the following characteristics:
Blood pressure > 130/85 mm Hg
plasma glucose > 100 mg/dL
plasma triglycerides > 150 mg/dL
HDL cholesterol < 40 mg/dL (men) and < 50 mg/dL (women)
waist circumference >102 cm (men) and ≥ 88 cm (women)
Women of childbearing age should be using contraception
Exclusion Criteria:
Exclusion criteria will be
self-reported diabetes mellitus
coronary heart disease
triglycerides greater than 400 mg/dL
Fasting glucose greater than 126 mg/dL
Blood pressure greater than 140/100 mmg Hg
history of stroke
Use of alcohol at an elevated rate (more than two drinks per day)
Renal problems
liver disease
cancer
pregnancy and lactation
severe infectious diseases
autoimmune disease currently under treatment
current hormone therapy
previous treatment with TA-65.
Intake of glucose-lowering prescriptions
Use of immunosuppressants, lithium or supplements such as Sulphonylureas (Glucotrol, Amaryl), Thiazolidinedione (Avandia, ACTOS,), Meglitinides (Prandin, Starlix), Biguanides (Metformin), Alpha-glucosidase inhibitors (Precose, Glyset), dipeptidyl peptidase (DPP)-4 inhibitors (Januvia, Onglyza)
high dose chromium or cinnamon supplements
Consistent intake of vitamin, mineral, or multivitamin supplements prior to recruitment may be admitted into the study if they plan on maintaining their current supplement program.
However, subjects may not participate if they begin taking a new supplement during the 27-wk study period.
-Subjects will also be asked to refrain from taking any additional supplements, including fish oil, herb and concentrated antioxidant sources.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria-Luz Fernandez, Ph.D.
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20383691
Citation
Maubaret CG, Salpea KD, Jain A, Cooper JA, Hamsten A, Sanders J, Montgomery H, Neil A, Nair D, Humphries SE; HIFMECH consortium, Simon Broome Research Group. Telomeres are shorter in myocardial infarction patients compared to healthy subjects: correlation with environmental risk factors. J Mol Med (Berl). 2010 Aug;88(8):785-94. doi: 10.1007/s00109-010-0624-3. Epub 2010 Apr 11.
Results Reference
background
Links:
URL
http://www.tasciences.com/
Description
Sponsor Company
Learn more about this trial
The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
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