Health Status and Quality of Life in the Elderly

Not Applicable

Terminated

• Conditions: Quality of Life
• Interventions: Dietary Supplement: AMP-886; Other: Placebo

• Registration Number: NCT01953172
• Lead Sponsor: Unilever R&D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Study Start: 2013-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMP-886 (alpha-tocotrienol) in capsules	AMP-886	AMP-886 (alpha-tocotrienol) in capsules
Placebo capsules	Placebo	Placebo capsules

Primary Outcome Measures

Name	Time	Method
Effects on health status and quality of life	up to 24 weeks	Objective of this exploratory study is to evaluate the effects of AMP886 on vision

Trial Locations

Locations (3)

Central Manchester Hospital; 🇬🇧 Manchester, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

Whipps Cross Hospital; 🇬🇧 London, United Kingdom