NCT01953172

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 11, 2015

Status Verified

February 1, 2015

Enrollment Period

11 months

First QC Date

September 13, 2013

Last Update Submit

March 10, 2015

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (7)

  • Effects on health status and quality of life

    Objective of this exploratory study is to evaluate the effects of AMP886 on health status

    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

    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

    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

    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

    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

    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

    up to 24 weeks

Study Arms (2)

Placebo capsules

PLACEBO COMPARATOR

Placebo capsules

Other: Placebo

AMP-886 (alpha-tocotrienol) in capsules

EXPERIMENTAL

AMP-886 (alpha-tocotrienol) in capsules

Dietary Supplement: AMP-886

Interventions

AMP-886DIETARY_SUPPLEMENT

AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules

Also known as: alpha-tocotrienol
AMP-886 (alpha-tocotrienol) in capsules
PlaceboOTHER

Placebo

Placebo capsules

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Whipps Cross Hospital

London, E11 1NR, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Central Manchester Hospital

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Interventions

tocotrienol, alpha

Study Officials

  • C Verhoeven, PhD

    Unilever Research and Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2013

First Posted

September 30, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 11, 2015

Record last verified: 2015-02

Locations

GB(3)