Quality of LifeNCT01953172
Health Status and Quality of Life in the Elderly
A study testing AMP-886 in people with Quality of Life, run by Unilever R&D at 3 sites in United Kingdom.
Trial summary
The study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health status and quality of life measures, cognitive functioning, oxidative stress, inflammation markers and other symptoms effects on skin, sleep and vision in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- AMP-886
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2013to Sep 2014
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males and females 65-85 years old
- ECOG Performance score 0 to 1
- Body mass index 22-30 kg/m2
- Body weight >60 kg
- Habit to consume standard breakfast like toast, bread, butter/margarine, eggs, bacon, cereals with milk
- Comply with protocol and likely to be compliant with prescribed product
Who cannot join
- Renal insufficiency or failure at screening
- Current or previous positive documented history of any chronic inflammatory state including chronic infection, arthritis, or collagen vascular disorder.
- Comorbid medical conditions
- Use of prescription medication for chronic conditions
- Use of hormone replacement therapy (with the exception of levothyroxine)
- Uncontrolled hypertension
Show all 12Show fewer
- Use of hemostatic agents
- Hemorrhagic disorder and/or coagulation disorder
- Clinically important bleeding within 90 days prior to screening visit
- Fat malabsorption syndromes
- Constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy
- History of smoking within 1 year prior to visit 1.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Whipps Cross Hospital
London, E11 1NR
King's College Hospital
London, SE5 9RS
Central Manchester Hospital
Manchester, M13 9WL
About this study
Official title: Exploratory, Double-blind, Randomized, Placebo Controlled Study of AMP-886 in the Elderly
The study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health status and quality of life measures, cognitive functioning, oxidative stress, inflammation markers and other symptoms effects on skin, sleep and vision in the elderly.
- Conditions
- Quality of Life
- Being tested
- AMP-886, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMP-886Dietary supplement
Also called alpha-tocotrienol
AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsules | Placebo comparator | Placebo capsules Receives: Other: Placebo |
| AMP-886 (alpha-tocotrienol) in capsules | Experimental | AMP-886 (alpha-tocotrienol) in capsules Receives: Dietary Supplement: AMP-886 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on health status and quality of life
Objective of this exploratory study is to evaluate the effects of AMP886 on health status
Measured: up to 24 weeks
Effects on health status and quality of life
Objective of this exploratory study is to evaluate the effects of AMP886 on quality of life measures
Measured: up to 24 weeks
Effects on health status and quality of life
Objective of this exploratory study is to evaluate the effects of AMP886 on cognitive functioning
Measured: up to 24 weeks
Effects on health status and quality of life
Objective of this exploratory study is to evaluate the effects of AMP886 on oxidative stress
Measured: up to 24 weeks
Effects on health status and quality of life
Objective of this exploratory study is to evaluate the effects of AMP886 on inflammation markers
Measured: up to 24 weeks
Effects on health status and quality of life
Objective of this exploratory study is to evaluate the effects of AMP886 on skin
Measured: up to 24 weeks
Effects on health status and quality of life
Objective of this exploratory study is to evaluate the effects of AMP886 on vision
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- C Verhoeven, PhD, Study director, Unilever Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953172
- Sponsor's protocol ID
- FDS-NBU-1034
- Status last verified
- Feb 2015
- First submitted
- 13 Sep 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Double-blind, Randomized, Placebo Controlled Study of AMP-886 in the Elderly
- ClinicalTrials.gov ID
- NCT01953172
- Acronym / sponsor ID
- FDS-NBU-1034
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Sep 2013 (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 study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health status and quality of life measures, cognitive functioning, oxidative stress, inflammation markers and other symptoms effects on skin, sleep and vision in the elderly.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo capsules | Placebo comparator | Other: PlaceboPlacebo capsules |
| AMP-886 (alpha-tocotrienol) in capsules | Experimental | Dietary Supplement: AMP-886AMP-886 (alpha-tocotrienol) in capsules |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Males and females 65-85 years old
- ECOG Performance score 0 to 1
- Body mass index 22-30 kg/m2
- Body weight >60 kg
- Habit to consume standard breakfast like toast, bread, butter/margarine, eggs, bacon, cereals with milk
Key exclusion criteria (12 listed)
- Renal insufficiency or failure at screening
- Current or previous positive documented history of any chronic inflammatory state including chronic infection, arthritis, or collagen vascular disorder.
- Comorbid medical conditions
- Use of prescription medication for chronic conditions
- Use of hormone replacement therapy (with the exception of levothyroxine)
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 |
|---|---|---|
| AMP-886Also: alpha-tocotrienolAMP886 (alpha-tocotrienol) encapsulated in gelatin capsules | Dietary supplement | AMP-886 (alpha-tocotrienol) in capsules |
| PlaceboPlacebo | Other | Placebo capsules |
Primary outcome
Effects on health status and quality of life
Time frame: up to 24 weeks
Objective of this exploratory study is to evaluate the effects of AMP886 on health status
Effects on health status and quality of life
Time frame: up to 24 weeks
Objective of this exploratory study is to evaluate the effects of AMP886 on quality of life measures
Effects on health status and quality of life
Time frame: up to 24 weeks
Objective of this exploratory study is to evaluate the effects of AMP886 on cognitive functioning
Effects on health status and quality of life
Time frame: up to 24 weeks
Objective of this exploratory study is to evaluate the effects of AMP886 on oxidative stress
Effects on health status and quality of life
Time frame: up to 24 weeks
Objective of this exploratory study is to evaluate the effects of AMP886 on inflammation markers
Effects on health status and quality of life
Time frame: up to 24 weeks
Objective of this exploratory study is to evaluate the effects of AMP886 on skin
Effects on health status and quality of life
Time frame: up to 24 weeks
Objective of this exploratory study is to evaluate the effects of AMP886 on vision
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
C Verhoeven, PhD study director
Unilever Research and Development
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMP-886 in people with Quality of Life, run by Unilever R&D at 3 sites in United Kingdom.
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 6 inclusion and 12 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment problems). 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?
Effects on health status and quality of life (time frame: up to 24 weeks). The study lists 7 primary outcomes in all. 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 11 Mar 2015.