Health Status and Quality of Life in the Elderly

Overview

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.

Full Title of Study: “Exploratory, Double-blind, Randomized, Placebo Controlled Study of AMP-886 in the Elderly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2014

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo capsules
    • Placebo capsules
  • Experimental: AMP-886 (alpha-tocotrienol) in capsules
    • AMP-886 (alpha-tocotrienol) in capsules

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Unilever R&D
  • Collaborator
    • Sprim Advanced Life Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • C Verhoeven, PhD, Study Director, Unilever Research and Development

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