Health Status and Quality of Life in the Elderly

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01953172

Enrollment

Registered

2013-09-30

Start date

2013-10-31

Completion date

2014-09-30

Last updated

2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTAMP-886

AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Effects on health status and quality of life	up to 24 weeks	Objective of this exploratory study is to evaluate the effects of AMP886 on health status

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026