Health Status and Quality of Life in the Elderly

Unilever

Status

Terminated

Conditions

Quality of Life

Treatments

Dietary Supplement: AMP-886

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01953172

FDS-NBU-1034

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

65 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.