Healthy VolunteersNCT01752868
Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?
A study testing Supplement in people with Healthy Volunteers, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if a combination of 10 nutritional supplements provide health benefits that are consistent with protection against age-related disease. All supplements have been shown in previous studies to have health benefits when administered alone. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2012
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 40-60 yr
- body mass index of 21 - 30 kg/m2
- sedentary to moderately active
- eating a typical US diet
Who cannot join
- history of any chronic disease other than mild osteoarthritis
- use of medications other than occasional use of non-steroidal anti-inflammatory drugs, antihistamines, antacids or laxatives
- use of nutritional supplements
- smoking
- alcohol intake greater than two drinks per day for women and three drinks per day for men
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Medical Center
St Louis, Missouri, 63110
About this study
The purpose of this study is to determine if a combination of 10 nutritional supplements provide health benefits that are consistent with protection against age-related disease. All supplements have been shown in previous studies to have health benefits when administered alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will provide beneficial changes in healthy related measures.
- Conditions
- Healthy Volunteers
- Being tested
- Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementDietary supplement
Participants in this group will take the following nutritional supplements on a daily basis: curcumin, fish oil, resveratrol, sesamin, Acetyl-L-carnitine, lipoic acid, green and black teas, quercetin, pomegranate, cinnamon bark.
| Study group | Role | What they receive |
|---|---|---|
| supplement | Experimental | Not described Receives: Dietary Supplement: Supplement |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid-femoral pulse wave velocity
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Luigi Fontana, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752868
- Sponsor's protocol ID
- BJH 6936-33
- Status last verified
- Dec 2012
- First submitted
- 14 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?
- ClinicalTrials.gov ID
- NCT01752868
- Acronym / sponsor ID
- BJH 6936-33
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 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.
The purpose of this study is to determine if a combination of 10 nutritional supplements provide health benefits that are consistent with protection against age-related disease. All supplements have been shown in previous studies to have health benefits when administered alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will provide beneficial changes in healthy related measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supplement | Experimental | Dietary Supplement: Supplement |
| control | No intervention | – |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 40-60 yr
- body mass index of 21 - 30 kg/m2
- sedentary to moderately active
- eating a typical US diet
Key exclusion criteria (5 listed)
- history of any chronic disease other than mild osteoarthritis
- use of medications other than occasional use of non-steroidal anti-inflammatory drugs, antihistamines, antacids or laxatives
- use of nutritional supplements
- smoking
- alcohol intake greater than two drinks per day for women and three drinks per day for men
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 |
|---|---|---|
| SupplementParticipants in this group will take the following nutritional supplements on a daily basis: curcumin, fish oil, resveratrol, sesamin, Acetyl-L-carnitine, lipoic acid, green and black teas, quercetin, pomegranate, cinnamon bark. | Dietary supplement | supplement |
Primary outcome
Carotid-femoral pulse wave velocity
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
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Screening Protocol
Pain
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.
Luigi Fontana, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Healthy Volunteers, run by Washington University School of Medicine 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Dec 2012. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Carotid-femoral pulse wave velocity (time frame: Baseline and 6 months). 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 19 Dec 2012.