Metabolic SyndromePhase 1NCT01753674
The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
A Phase 1 study testing TA-65 in people with Metabolic Syndrome and Insulin Resistance, run by University of Connecticut at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance
- What is being tested?
- TA-65
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 1
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Our hypothesis is that TA-65, a dietary supplement will help to reduce insulin resistance and plasma glucose in individuals classified with metabolic syndrome.
Read the 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.
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Being tested
- TA-65, Placebo
- Keywords
- metabolic syndrome, insulin resistance, HDL cholesterol,
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-65Dietary supplement
TA-65 will be provided to volunteers, 2 pills per day of 8 mg each
PlaceboDietary supplement
Placebo supplement will be provided to volunteers, 2 pills per day of 8 mg each
| Study group | Role | What they receive |
|---|---|---|
| TA-65 | Experimental | TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each Receives: Dietary Supplement: TA-65 |
| Placebo | Placebo comparator | Placebo will be provided to volunteers for 12 weeks, 2 pills per day of 8 mg each. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 27 weeks
Secondary outcomes (1)
plasma HDL cholesterol
It is expected that the TA-65 supplement will increase plasma HDL, another characteristic of metabolic syndrome
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: non-compliance issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria-Luz Fernandez, Ph.D., Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753674
- Sponsor's protocol ID
- H12-256
- Other IDs
- TAS-12-035
- Status last verified
- May 2015
- First submitted
- 17 Dec 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20383691
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01753674
- Acronym / sponsor ID
- H12-256
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Keywords
- metabolic syndrome, insulin resistance, HDL cholesterol,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: non-compliance issues
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Dec 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TA-65 | Experimental | Dietary Supplement: TA-65TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo will be provided to volunteers for 12 weeks, 2 pills per day of 8 mg each. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| TA-65TA-65 will be provided to volunteers, 2 pills per day of 8 mg each | Dietary supplement | TA-65 |
| PlaceboPlacebo supplement will be provided to volunteers, 2 pills per day of 8 mg each | Dietary supplement | Placebo |
Primary outcome
Plasma insulin levels
Time frame: 27 weeks
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
1 secondary outcome
plasma HDL cholesterol
Time frame: 27 weeks
Results and safety
The study was stopped early (reason given: non-compliance issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 20383691Maubaret 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.
- Sponsor CompanyLink provided by the sponsor.
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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.
Maria-Luz Fernandez, Ph.D. principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TA-65 in people with Metabolic Syndrome and Insulin Resistance, run by University of Connecticut at 1 site 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 8 inclusion and 21 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: stopped early, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: non-compliance issues). Results are not available in the source record.
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?
Plasma insulin levels (time frame: 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753674, which also lists 1 linked publication.
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 28 May 2015.