Health Status and Quality of Life in the Elderly

N/ATerminatedNCT01953172

Unilever R&D12 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Quality of Life

Interventions

AMP-886DIETARY_SUPPLEMENT

AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Whipps Cross Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

Central Manchester Hospital

Manchester, United Kingdom