Health Status and Quality of Life in the Elderly

Study Overview
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Brief Summary
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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.

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

Conditions
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Quality of Life

Intervention / Treatment
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* Dietary Supplement: AMP-886
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo capsules<br>Placebo capsules | Other: Placebo<br>* Placebo<br>|
| Experimental: AMP-886 (alpha-tocotrienol) in capsules<br>AMP-886 (alpha-tocotrienol) in capsules | Dietary Supplement: AMP-886<br>* AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules<br>* Other names: alpha-tocotrienol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |