Study Stopped
non-compliance issues
The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
2 other identifiers
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMay 28, 2015
May 1, 2015
1.4 years
December 17, 2012
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
27 weeks
Secondary Outcomes (1)
plasma HDL cholesterol
27 weeks
Other Outcomes (1)
blood pressure
27 weeks
Study Arms (2)
TA-65
EXPERIMENTALTA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each
Placebo
PLACEBO COMPARATORPlacebo will be provided to volunteers for 12 weeks, 2 pills per day of 8 mg each.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Connecticut
Storrs, Connecticut, 06269, United States
Related Publications (1)
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.
PMID: 20383691BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria-Luz Fernandez, Ph.D.
University of Connecticut
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 20, 2012
Study Start
January 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
May 28, 2015
Record last verified: 2015-05