Oxidative DNA DamageNCT00356252
Biological Functions of Carotenoids in Humans
A study testing mixed carotenoids in people with Oxidative DNA Damage, run by Tufts University at 1 site in United States.
Trial summary
This study will examine the the efficiency fo absorption of major plant pigments, carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of carotenoids in healthy women in response to an 8-week period of carotenoid supplementation. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative DNA Damage
- What is being tested?
- mixed carotenoids
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Dec 2003
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting.
Who cannot join
- Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders. Exogenous hormone users, smokers. Subjects weighing greater than 20% above or below the NHANES median standard.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA-Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, 02111
About this study
Official title: Functional Bioavailability of Carotenoids in Humans
This study will examine the the efficiency fo absorption of major plant pigments, carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.
The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the circulation will be measured every other week throughout the study period.
- Conditions
- Oxidative DNA Damage
- Being tested
- mixed carotenoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed carotenoidsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA damage
plasma carotenoid concentrations
Secondary outcomes (2)
lipid peroxidation
Total antioxidant capacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startApr 2002
- Study completionDec 2003
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 Oxidative DNA DamageStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- BASF
- Investigators
- Kyung-Jin Yeum, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356252
- Sponsor's protocol ID
- HNRCA1860
- Other IDs
- PV1087
- Status last verified
- Jul 2008
- First submitted
- 24 Jul 2006
- Last updated
- 24 Jul 2008
- Results posted
- No
Publications
Zhao X, Aldini G, Johnson EJ, Rasmussen H, Kraemer K, Woolf H, Musaeus N, Krinsky NI, Russell RM, Yeum KJ. Modification of lymphocyte DNA damage by carotenoid supplementation in postmenopausal women. Am J Clin Nutr. 2006 Jan;83(1):163-9. doi: 10.1093/ajcn/83.1.163.
PubMed 16400064
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Bioavailability of Carotenoids in Humans
- ClinicalTrials.gov ID
- NCT00356252
- Acronym / sponsor ID
- HNRCA1860
- Conditions
- Oxidative DNA Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- BASF
- Study start
- Apr 2002
- Study completion
- Dec 2003
- First posted
- 25 Jul 2006 (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.
This study will examine the the efficiency fo absorption of major plant pigments, carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.
The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the circulation will be measured every other week throughout the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting.
Key exclusion criteria (1 listed)
- Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders. Exogenous hormone users, smokers. Subjects weighing greater than 20% above or below the NHANES median standard.
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 |
|---|---|---|
| mixed carotenoids | Drug | – |
Primary outcome
DNA damage
plasma carotenoid concentrations
2 secondary outcomes
lipid peroxidation
Total antioxidant capacity
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 24 Jul 2008.
- Results publication: PubMed 16400064Zhao X, Aldini G, Johnson EJ, Rasmussen H, Kraemer K, Woolf H, Musaeus N, Krinsky NI, Russell RM, Yeum KJ. Modification of lymphocyte DNA damage by carotenoid supplementation in postmenopausal women. Am J Clin Nutr. 2006 Jan;83(1):163-9. doi: 10.1093/ajcn/83.1.163.
- ArticleLink provided by the sponsor.
Related trials for Oxidative DNA Damage
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
NEUROmuscular Training for Enhanced AGE Longevity
Aging, Physical Activity
Active, not recruiting
Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters
Aging, Obesity
Recruiting
The Effect of Cardiac Rehabilitation on Oxidative DNA Damage and Inflammation in Patients With Coronary Artery Disease
Coronary Arterial Disease (CAD)
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.
Kyung-Jin Yeum, PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mixed carotenoids in people with Oxidative DNA Damage, run by Tufts University 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 1 inclusion and 1 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 24 Jul 2008. 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?
DNA damage. 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?
On the ClinicalTrials.gov record for NCT00356252, 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 24 Jul 2008.