Health Status and Quality of Life in the Elderly

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

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life
• Intervention / Treatment: Other: Placebo; Dietary supplement: AMP-886

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • London, United Kingdom, E11 1NR
    • Whipps Cross Hospital
  • Manchester, United Kingdom, M13 9WL
    • Central Manchester Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo capsules	Other: Placebo; Placebo
EXPERIMENTAL: AMP-886 (alpha-tocotrienol) in capsules	Dietary supplement: AMP-886; AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules; Other Names: alpha-tocotrienol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Study Director: C Verhoeven, PhD, Unilever Research and Development

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: September 13, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (ESTIMATE): September 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Tocotrienols; Tocotrienol, alpha
• Other Study ID Numbers: FDS-NBU-1034