Health Status and Quality of Life in the Elderly
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 01/31/2015 |
| Pirmasis pateikimas: | 09/12/2013 |
| Numatytas registravimas pateiktas: | 09/24/2013 |
| Pirmas paskelbtas: | 09/29/2013 |
| Paskutinis atnaujinimas pateiktas: | 03/09/2015 |
| Paskutinis atnaujinimas paskelbtas: | 03/10/2015 |
| Faktinė studijų pradžios data: | 09/30/2013 |
| Numatoma pirminio užbaigimo data: | 08/31/2014 |
| Numatoma studijų užbaigimo data: | 08/31/2014 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: AMP-886 (alpha-tocotrienol) in capsules
Other: Placebo capsules
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Placebo Comparator: Placebo capsules Placebo capsules | Other: Placebo capsules Placebo |
| Experimental: AMP-886 (alpha-tocotrienol) in capsules AMP-886 (alpha-tocotrienol) in capsules | Dietary Supplement: AMP-886 (alpha-tocotrienol) in capsules AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 65 Years Į 65 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. Effects on health status and quality of life [up to 24 weeks]
2. Effects on health status and quality of life [up to 24 weeks]
3. Effects on health status and quality of life [up to 24 weeks]
4. Effects on health status and quality of life [up to 24 weeks]
5. Effects on health status and quality of life [up to 24 weeks]
6. Effects on health status and quality of life [up to 24 weeks]
7. Effects on health status and quality of life [up to 24 weeks]
