Health Status and Quality of Life in the Elderly

Quality of Life Clinical Trial

Official title:

Exploratory, Double-blind, Randomized, Placebo Controlled Study of AMP-886 in the Elderly

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01953172
• Other study ID #: FDS-NBU-1034
• Status: Terminated
• Phase: N/A
• First received: September 13, 2013
• Last updated: March 10, 2015
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Quality of Life

Intervention

Dietary Supplement:
• AMP-886
AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London
United Kingdom	Whipps Cross Hospital	London
United Kingdom	Central Manchester Hospital	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Sprim Advanced Life Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No